FDA – MEDWATCH

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March 2011 Safety Labeling Changes: 55 Medical Product Labels with changes to Warnings, Contraindications, Precautions, Adverse Reactions

The MedWatch March 2011 Safety Labeling Changes posting includes 55 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.
The “Summary Page” provides a listing of drug names and safety labeling sections revised: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm249643.htm

The following drugs had modifications to the BOXED WARNINGS, CONTRAINDICATIONS and WARNINGS sections:

Accuretic (quinapril HCL/hydrochlorothiazide)
Advil Cold & Sinus Liqui-Gels (ibuprofen 200 mg and pseudoephedrine HCl 30 mg)
Atacand HCT (candesartan cilexitil/hydrochlorothiazide)
Azasite (azithromycin)
Dutoprol (metoprolol succinate extended release/hydrochlorothiazide)
Dyazide (hydrochlorothiazide/triamterene)
Etopophos (etoposide phosphate)
Fareston (toremifene citrate)
Inderal (propranolol HCL)
Inderal LA (propranolol hydrochloride)
Inderide (propranolol hydrochloride/hydrochlorothiazide)
Integrilin (eptifibatide)
Letairis (ambrisentan)
Lioresal (baclofen)
Lopressor (metoprolol tartrate)
Lopressor HCT (metoprolol tartrate/hydrochlorothiazide)
Lotensin HCT (benazapril hydrochloride/hydorchlorothiazide)
Maxzide and Maxzide-25 (triamterene/hydrochlorothiazide) and
Microzide (hydrochlorothiazide)
Ortho Evra (norelgestromin/ethinyl estradiol)
PhosLo (calcium acetate)
Rotarix (Rotavirus Vaccine, Live, Oral)
Sectral (acebutolol hydrochloride)
Strattera (atomoxetine hydrochloride)
Talacen (pentazocine hydrochloride and acetaminophen)
Tekamlo (aliskiren/amlodipine)
Topamax (topiramate)
Tribenzor (olmesartan medoxomil / amlodipine / hydrochlorothiazide)
Vaseretic (enalapril maleate/hydrochlorothiazide)
Yaz (drospirenone/ethinyl estradiol)
Zestoretic (lisinopril/hydrochlorothiazide)

Posted 04/12/2011

FDA MedWatch – Soladek Vitamin Solution: Unapproved Product May Contain Dangerously High Levels of Vitamins A, D

AUDIENCE: Consumer
ISSUE: Tested samples of Soladek contained levels of vitamin A and vitamin D that were many times the recommended daily allowances for these vitamins. Intake of excessively high levels of these vitamins poses a risk to human health. Symptoms of vitamin A toxicity include anemia, anorexia, alopecia, joint pain, bone weakness, bulging eyes, liver abnormalities, and birth defects. Symptoms of vitamin D toxicity include weakness, fatigue, headache, nausea, vomiting, diarrhea, changes in mental status, increased blood pressure, abnormal heart rate or rhythm, kidney damage, and coma.
BACKGROUND: Soladek is marketed with claims that the product treats “hypo and avitaminosis, rickets, growth, dentition, lactation, fractures, infection, convalescence, protection and regeneration of certain epithelium (bronchial, glandular, ocular, cutaneous), corticotherapy, aging and pregnancy.” The product is sold in a box labeled in Spanish and containing a vial of the solution.
The FDA received seven reports of serious health problems occurring in consumers using the product. The problems include decreased renal function, elevated levels of calcium in the blood, fatigue, heart arrhythmia, vomiting, and diarrhea.
RECOMMENDATION: Consumers who are in possession of Soladek should stop using the product immediately. Any consumers who have been using Soladek and are experiencing any of the above symptoms should see a doctor immediately.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the Press Release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm248738.htm

Posted 04/04/2011

Roche ACCU-CHEK FlexLink Plus Infusion Set: Class I Recall – Potential for Under-Delivery of Insulin

AUDIENCE: Endocrinology, Patients
ISSUE: There is a potential for under-delivery of insulin due to a tube (cannula) which may become kinked or bent when inserting the ACCU-CHEK FlexLink Plus infusion set. If this remains unnoticed, this can result in under-delivery or no delivery of insulin. This can lead to elevated blood glucose levels (hyperglycemia). Hyperglycemia can lead to many serious health complications including death.
BACKGROUND: This recall only applies to the ACCU-CHEK FlexLink Plus infusion sets that were launched in November 2010. ACCU-CHEK Ultraflex, other Accu-Chek infusion sets or insulin pumps are not affected by this recall and can be continued as directed by a physician or other qualified health care provider.
RECOMMENDATION: The company requested its customers to stop using the ACCU-CHEK FlexLink Plus infusion sets and return the unused products. Patients are to contact their health care providers or caregivers to determine if changes to their therapy are needed and how to temporarily continue insulin pump therapy without the ACCU-CHEK FlexLink Plus infusion set.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the FDA Class I recall notice, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm248784.htm

Posted 03/30/2011

&P Industries Povidine Iodine Prep Pads

Including products under brand names Cardinal Health, Medical Specialties, VHA, Triad, Triad Plus, North Safety, Total Resources

AUDIENCE: Pharmacy, Consumer, Risk Manager
ISSUE: H&P industries, Inc., a manufacturer of over-the-counter products, initiated a voluntary product recall of ALL LOTS of Povidine Prep Pads manufactured by H&P Industries, Inc. but which are private labeled for many accounts. Analytical testing showed the presence of Elizabethkingia meningoseptica. Use of contaminated Povidine Prep Pads could lead to life-threatening infections, especially in at risk populations, including neonates, immune suppressed patients, and surgical patients. Treatment options are limited for Elizabethkingia meningoseptica infections.
BACKGROUND: Povidine Iodine Prep Pads are used to prevent infection in minor cuts, scrapes and burns and are labeled as an antiseptic for preparation of the skin prior to surgery. They were distributed nationwide to healthcare customers and are packaged in individual packets and sold in a box of 100 packets.
RECOMMENDATION: Healthcare organizations should contact H&P Industries Customer Service to arrange a return. If a consumer has any of these types of products in their possession, they should not use the product.
Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the Press Release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm247743.htm

Posted 03/21/2011

merican Regent Injectable Products: Recall – Visible Particulates in Products (UPDATE)
· Bacteriostatic Sodium Chloride Injection, USP, 0.9%, 30 mL Multiple Dose Vials
· Concentrated Sodium Chloride Injection, USP 23.4%, 30 mL Single Dose Vials and 100mL Pharmacy Bulk Packages
· Sodium Thiosulfate Injection USP 10%
· Potassium Phosphates Injection, USP
AUDIENCE: Pharmacy
ISSUE: Recall initiated because some vials exhibit translucent visible particles consistent with glass delamination. Potential adverse events after intravenous administration include damage to blood vessels in the lung, localized swelling, and granuloma formation.
BACKGROUND: Glass delamination can occur with high pH solutions when the surface glass from the vial separates into thin layers, resulting in glass particles with a flaky appearance.
RECOMMENDATION: Hospitals, Home Health Care Agencies, Emergency Rooms, Infusion Centers, Clinics and other healthcare facilities should not use the recalled American Regent products. Recalled products should be immediately quarantined for return. Refer to Press Releases for specific lot numbers recalled.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Posted 03/17/2011

The MedWatch February 2011 Safety Labeling Changes posting includes 53 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.

The “Summary Page” provides a listing of drug names and safety labeling sections revised:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm242998.htm

The following drugs had modifications to the BOXED WARNINGS, CONTRAINDICATIONS and WARNINGS sections:

Avandia (rosiglitazone maleate) Avandamet (rosiglitazone maleate/metformin hydrochloride) and Avandaryl (rosiglitazone maleate/glimepiride) Tablets
Avelox (moxifloxacin hydrochloride) tablets and Avelox (moxifloxacin hydrochloride in NaCl injection) I.V.
Cipro (ciprofloxacin hydrochloride) Tablets, Oral Suspension, IV and Cipro XR (ciprofloxacin extended-release tablets)
Factive (gemifloxacin mesylate) Tablets
Floxin (ofloxacin) Tablets
Heparin Sodium Injection, USP
Humatrope (somatropin [rDNA origin]) for injection
Increlex (mecasermin [rDNA origin] injection
Kaletra (lopinavir/ritonavir) Tablets and Oral Solution
Levaquin (levofloxacin) Tablets, Oral Solution and Injection
Multaq (dronedarone hydrochloride) Tablets
Noroxin (norfloxacin) Tablets
Prilosec OTC (omeprazole magnesium) delayed-release tablets
Promacta (eltrombopag) Tablets
Proquin XR (ciprofloxacin) Extended-Release Tablets
Remicade (Infliximab)
Tekturna (aliskiren) and Tekturna HCT (aliskiren/hydrochlorothiazide) Tablets
Toviaz (fesoterodine fumarate) Extended Release Tablets
Valturna (aliskiren/valsartan) Tablets
Zebeta (bisoprolol fumarate) Tablets

Tell us how we are doing:
http://survey.foreseeresults.com/survey/display?cid=d509U9xg0gZVxkMRcoMsQg==&sid=link&cpp[date]=03_15_2011_1830&cpp[type]=I

Posted 03/16/2011

Proton Pump Inhibitor drugs (PPIs): Drug Safety Communication – Low Magnesium Levels Can Be Associated With Long-Term Use

Prescription PPIs include Nexium (esomeprazole magnesium), Dexilant (dexlansoprazole), Prilosec (omeprazole), Zegerid (omeprazole and sodium bicarbonate), Prevacid (lansoprazole), Protonix (pantoprazole sodium), AcipHex (rabeprazole sodium), and Vimovo (a prescription combination drug product that contains a PPI (esomeprazole magnesium and naproxen).
Over-the-counter (OTC) PPIs include Prilosec OTC (omeprazole), Zegerid OTC (omeprazole and sodium bicarbonate), and Prevacid 24HR (lansoprazole).

AUDIENCE: Consumer, Gastroenterology, Family Practice
ISSUE: FDA notified healthcare professionals and the public that prescription proton pump inhibitor (PPI) drugs may cause low serum magnesium levels (hypomagnesemia) if taken for prolonged periods of time (in most cases, longer than one year). Low serum magnesium levels can result in serious adverse events including muscle spasm (tetany), irregular heartbeat (arrhythmias), and convulsions (seizures); however, patients do not always have these symptoms. Treatment of hypomagnesemia generally requires magnesium supplements. In approximately one-quarter of the cases reviewed, magnesium supplementation alone did not improve low serum magnesium levels and the PPI had to be discontinued.
BACKGROUND: PPIs work by reducing the amount of acid in the stomach and are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus.
RECOMMENDATION: Healthcare professionals should consider obtaining serum magnesium levels prior to initiation of prescription PPI treatment in patients expected to be on these drugs for long periods of time, as well as patients who take PPIs with medications such as digoxin, diuretics or drugs that may cause hypomagnesemia. For patients taking digoxin, a heart medicine, this is especially important because low magnesium can increase the likelihood of serious side effects. Healthcare professionals should consider obtaining magnesium levels periodically in these patients. For additional information, refer to the Data Summary section of the FDA Drug Safety Communication.
Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the Drug Safety Communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm245275.htm

Posted 03/02/2011

Abacavir – Ongoing Safety Review: Possible Increased Risk of Heart Attack

including Ziagen, Trizivir, and Epzicom

AUDIENCE: Infectious Disease

ISSUE: FDA updated the public about an ongoing safety review of abacavir and a possible increased risk of heart attack. There has been conflicting information on the potential increased risk of heart attack with abacavir treatment. An increased risk of heart attack (myocardial infarction or MI) has been seen in several observational studies and one randomized controlled trial (RCT) with abacavir. However, an increased risk of heart attack has not been seen in other RCTs and the safety database maintained by the drug manufacturer.

FDA conducted a meta-analysis of 26 randomized clinical trials that evaluated abacavir. This meta-analysis did not show an increased risk of MI associated with the use of abacavir. FDA will continue to communicate any new safety information to the public as it becomes available.

BACKGROUND: Abacavir is an antiviral medication used in combination with other antiretroviral drugs for the treatment of HIV-1 infection.

RECOMMENDATION: Healthcare professionals should continue to prescribe abacavir according to the professional label. Patients should not stop taking their abacavir without first talking to their healthcare professional.

Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

* Complete and submit the report Online: www.fda.gov/MedWatch/report.htm<http://www.fda.gov/MedWatch/report.htm>
* Download form<http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm> or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the Drug Safety Communication, at:

http://www.fdaov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm245190.htm

Posted 03/02/2011

FDA MedWatch – January 2011 Safety Labeling Changes; 43 products with revisions to Prescribing Information

The MedWatch January 2011 Safety Labeling Changes posting includes 43 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.
The “Summary Page” provides a listing of drug names and safety labeling sections revised:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm240075.htm

Clicking on a drug product name in the Summary View will take you to the “detailed view” page, which identifies safety labeling sections and subsections revised, along with a brief summary of new or modified safety information.
The following drugs had modifications to the BOXED WARNINGS, CONTRAINDICATIONS and WARNINGS sections:

Carbatrol (carbamazepine)
EES (erythromycin ethylsuccinate)
Ery-Ped (erythromycin ethylsuccinate)
PCE (erythromycin particles in tablets) Dispertab
Gelnique (oxybutynin chloride) 10% gel
Uloric (febuxostat tablets)
Zithromax (azithromycin)
Actonel (risedronate sodium)
Actonel with Calcium (risedronate sodium with calcium carbonate tablets, USP)
Atelvia (risedronate sodium)
Boniva (ibandronate sodium)
Coreg (carvedilol)
Coreg CR (carvedilol phosphate)
Cyklokapron (tranexamic acid)
Folotyn (pralatrexate)
Fosamax (alendronate sodium)
Fosamax Plus D (alendronate sodium/cholecalciferol)
Kayexalate (sodium polystyrene sulfonate)
Oxytrol (oxybutynin transdermal system)
Prilosec (omeprazole)
Prilosec (omeprazole magnesium)
Reclast (zoledronic acid)
Rituxan (rituximab)
Sanctura (trospium chloride)
Sanctura XR (trospium chloride extended release capsules)
Tasigna (nilotinib)
Tessalon (benzonatate)
Trelstar (triptorelin palmoate)
Viagra (sildenafil citrate)
Zoladex (goserelin acetate)

Posted 02/24/2011

Warfarin Sodium Tablets (Jantoven), 3mg: Recall – Mislabeled Bottles Containing Higher Dosage

AUDIENCE: Pharmacy, Family Practice, Consumer
ISSUE: Upsher-Smith Laboratories and FDA notified healthcare professionals of the recall of one lot of Jantoven Warfarin Sodium, USP, 3mg Tablets, an anticoagulant, after a single bottle labeled as Jantoven Warfarin Sodium, USP, 3mg Tablets was found to contain tablets at a higher 10mg strength. To date, the company has identified no additional mislabeled bottles.
BACKGROUND: The recalled lot is numbered as #284081, with an expiration date of September 2012. The product lot was distributed to wholesalers, retail chains and independent pharmacies throughout the United States. The primary risk of substituting 10mg warfarin for 3mg warfarin is overdosing more than 3 times the labeled amount which leads to excessive anticoagulation that could be expected to result in life-threatening hemorrhage in patients.
RECOMMENDATION: The two Jantoven tablets (see photo at link below) can be readily identified by color: the 3mg tablet is tan and the 10mg tablet is white. In addition, the 3mg tablet is imprinted with the letters WRF, a line, and the number 3 below the line. The reverse side of the 3mg tablet carries the number 832. The 10mg tablet is imprinted with the letters WRF, a line, and the number 10 below the line. The reverse side of the 10mg tablet carries the number 832. Consumers and pharmacists can call the Upsher-Smith medical information line at 1-888-650-3789 for more information and to access product details, Monday-Friday between 8:00 a.m. and 5:00 p.m. (CST).

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including links to the company press release and product photos, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm243850.htm

Posted 02/17/2011

Merit Prelude Short Sheath Catheter Introducer: Class I Recall – Tip May Detach During Use

AUDIENCE: Cardiology, Nephrology, Risk Manager
ISSUE: Introducer tip may detach during use, causing arterial injury, hemorrhaging, or other serious events, while introducer tip material may enter into the bloodstream, causing blood clots (thrombosis).
BACKGROUND: The Merit Prelude Short Sheath Catheter Introducer is used to provide access and facilitate the introduction of other medical devices into veins or arteries while maintaining hemostasis for a variety of procedures.
RECOMMENDATION: Merit Medical Systems, Inc. is advising customers to immediately discontinue use of any affected product, examine their inventory, and quarantine all affected product.

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, includinbg a link to the Class I recall notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm242343.htm

Posted 02/07/2011

American Regent Injectable Products: Recall – Visible Particulates in Products

Sodium Thiosulfate Injection USP 10%
Potassium Phosphates Injection, USP

AUDIENCE: Pharmacy
ISSUE: Recall initiated because some vials exhibit translucent visible particles consistent with glass delamination. Potential adverse events after intravenous administration include damage to blood vessels in the lung, localized swelling, and granuloma formation.
BACKGROUND: Glass delamination can occur with high pH solutions when the surface glass from the vial separates into thin layers, resulting in glass particles with a flaky appearance.
RECOMMENDATION: Hospitals, Home Health Care Agencies, Emergency Rooms, Infusion Centers, Clinics and other healthcare facilities should not use the recalled American Regent products. Recalled products should be immediately quarantined for return. Refer to Press Releases for specific lot numbers recalled.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, incljuding links to the company press releases, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm242365.htm

Posted 02/05/2011

Avandia (rosiglitazone): REMS – Risk of Cardiovascular Events

[UPDATED 02/04/2011] FDA notified healthcare professionals and patients that information on the cardiovascular risks (including heart attack) of rosiglitazone has been added to the physician labeling and patient Medication Guide. This information was first announced by FDA on September 23, 2010 as part of new restrictions for prescribing and use of this drug.
Rosiglitazone is sold as a single-ingredient product under the brand name Avandia. Rosiglitazone is also sold as a combination product under the brand name Avandamet (contains rosiglitazone and metformin) and under the brand name Avandaryl (contains rosiglitazone and glimepiride).
In addition to describing the cardiovascular risks, the drug labels have been revised to state that rosiglitazone and rosiglitazone-containing medicines should only be used:

In patients already being treated with these medicines
In patients whose blood sugar cannot be controlled with other anti-diabetic medicines and who, after consulting with their healthcare professional, do not wish to use pioglitazone-containing medicines (Actos, Actoplus Met, Actoplus Met XR, or Duetact).

Read the MedWatch safety alert, including links to the FDA Drug Safety Communication, labeling, and medication guide, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm226994.htm

Posted 02/04/2011

FDA MedWatch – B. Braun Outlook 400ES Safety Infusion System, Model Number 621-400ES: Class I Recall – Hardware May Become Unresponsive

[http://www.fda.gov/ucm/groups/fdagov-public/documents/image/ucm052224.gif] [http://www.fda.gov/ucm/groups/fdagov-public/documents/image/ucm162880.gif]

B. Braun Outlook 400ES Safety Infusion System, Model Number 621-400ES: Class I Recall – Hardware May Become Unresponsive

AUDIENCE: Risk Manager, Patient

ISSUE: Infusion systems upgraded with the Motorola compact flash hardware and supporting software, when used in a network environment that utilizes Temporal Key Integrity Protocol (TKIP) authentication, can potentially induce a memory leak that can cause the Management Processor to become non-responsive. This causes normal operation to stop, which is signaled by an audible backup alarm indicating that the pump is not delivering the medicine. There is no visual error warning to alert the user that the pump is not working.

BACKGROUND: The B. Braun Outlook 400ES Safety Infusion System is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid when the IV fluid container is lower than the pump and provides the accurate volume of all standard IV fluid, including blood, lipids, and Total Parenteral Nutrition (TPN).

RECOMMENDATION: Customers should deactivate the wireless communication on their pumps and return them to the manufacturer.

Read the MedWatch safety alert, including a link to the Recall Notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm241637.htm

Posted 02/04/2011

Fresenius Medical Care North America, CombiSet True Flow Series Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors for Use with the Blood Volume Monitor: Class I Recall – Potential for Kinking of Arterial Line

AUDIENCE: Nephrology/dialysis, Risk Manager
ISSUE: The hemodialysis blood tubing sets may develop kinking of the arterial line. Kinking can cause the destruction of red blood cells which may result in serious injury and/or death.
This recall affects ONLY Part Number 03-2695-9 and Part Number 03-2795-7.
These products were manufactured between June 11, 2010 and October 17, 2010. Part Number 03-2695-9 was distributed between August 2010 and November 2010. Part Number 03-2795-7 was distributed between August 2009 and November 2010.
BACKGROUND: The CombiSet Hemodialysis Blood Tubing Set is blood tubing used during hemodialysis. It is intended for single use only. The CombiSet Hemodialysis Blood Tubing Set may be used with conventional and high flux negative pressure hemodialyzer equipment.
RECOMMENDATION: Customers should immediately discontinue using the affected lots and place the products in a secure and separate area for return to the company.

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the FDA Class I Recall Notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm240588.htm

Posted 01/21/2011

December 2010 Safety Labeling Changes: 58 Medical Product Labels with changes to Boxed Warnings, Contraindications, Precautions, Adverse Reactions

The MedWatch December 2010 Safety Labeling Changes posting includes 58 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.

The “Summary Page” provides a listing of drug names and safety labeling sections revised:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm235838.htm

The following drugs had modifications to the BOXED WARNINGS, CONTRAINDICATIONS and WARNINGS sections:

Ablavar (gadofosveset trisodium)
Aceon (perindopril erbumine)
Baraclude (entecavir)
Copegus (ribavirin)
Eovist (Gadoxetate disodium) injection
Innopran XL (propranolol hydrochloride)
Magnevist (gadopentetate dimeglumine)
MultiHance (gadobenate dimeglumine)
Omniscan (gadodiamide)
Optimark (gadoversetamide)
Prilosec OTC (omeprazole magnesium)
Pristiq (desvenlafaxine)
Prohance (gadoteridol)
Relenza (zanamivir)
Remicade (inflximab)
Terconazole Vaginal Cream
Zegerid OTC capsules
Zerit (stavudine)

Tell us what you think: http://survey.foreseeresults.com/survey/display?cid=d509U9xg0gZVxkMRcoMsQg==&sid=link&cpp[date]=1-1-2011

Posted 01/17/2011

Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL): Medication Use Error – Reports of Accidental Overdose

AUDIENCE: Pharmacy, Oncology, Pain Management
ISSUE: Roxane Laboratories and FDA notified healthcare professionals of serious adverse events and deaths resulting from accidental overdose of morphine sulfate oral solutions, especially when using the high potency 100 mg/5mL product. In most of these cases, morphine sulfate oral solutions ordered in milligrams (mg) were mistakenly interchanged for milliliters (mL) of the product. The approval of this product is part of FDA’s unapproved drugs initiative. Prior to the recent approval, Roxane marketed a morphine sulfate oral solution with the strength expressed as 20 mg/mL, using a container label and carton labeling that had brown lettering on a white background. The newly approved product labeling and packaging feature revisions intended to reduce the risk of medication errors.
BACKGROUND: Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) is indicated for relief of moderate to severe acute and chronic pain in opioid-tolerant patients.
RECOMMENDATION: See Roxane’s “Dear Healthcare Professional Letter” for a complete description and photos of labeling and product packaging changes. Changes include:

A warning stating “ONLY FOR USE IN PATIENTS WHO ARE OPIOID TOLERANT” is displayed in a box to highlight that the morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL) is indicated for use in opioid-tolerant patients only. The 100 mg per 5 mL concentration of morphine sulfate may cause fatal respiratory depression when administered to patients not previously exposed to opioids.
The strength is presented as 100 mg per 5 mL followed by a less prominently displayed concentration of (20 mg/mL). The intent of this designation is to help differentiate this product from the 20 mg/5 mL morphine sulfate product.
A bright yellow background is used on multiple sides of this product to differentiate the morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL) from other morphine sulfate oral solutions marketed by Roxane with a white background.
The drug name, strength and concentration are displayed in white lettering on a red background as an additional means of differentiating this product from other concentrations of morphine sulfate oral solutions.
A reminder is presented to the pharmacist to dispense the product to each patient with the enclosed Medication Guide.
Both the 30 mL and 120 mL bottles of morphine sulfate 100 mg per 5 mL (20 mg/mL) oral solution are packaged with a calibrated oral syringe to provide accurate dose measurements. Healthcare providers should read the instructions in the Medication Guide that describe the correct use of the oral syringe in order to help prevent medication errors from occurring.
Healthcare providers should discuss the correct use of the oral syringe with their patients.

Read the MedWatch safety alert, including links to the Dear Healthcare Professional Letter and product Prescribing Information, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm239559.htm
Tell us how we are doing:

http://survey.foreseeresults.com/survey/display?cid=d509U9xg0gZVxkMRcoMsQg==&sid=link&cpp[date]=01_10_2011_1600&cpp[type]=S

Posted 01/11/2011

Triad Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks: Recall Due to Potential Microbial Contamination

Sold by Cardinal Health, PSS Select, VersaPro, Boca/Ultilet, Moore Medical, Walgreens, CVS, Conzellin
AUDIENCE: Pharmacy, Consumer
ISSUE: Triad Group, a manufacturer of over-the-counter products and FDA notified healthcare professionals and patients of the recall involving all lots of alcohol prep pads, alcohol swabs, and alcohol swabsticks manufactured by Triad but sold as private labels at the consumer level. This recall has been initiated due to concerns about potential contamination of the products with Bacillus cereus. This recall involves those products marked as STERILE as well as non-sterile products. Use of contaminated alcohol prep pads, alcohol swabs, and alcohol swabsticks could lead to life-threatening infections, especially in at-risk populations, including immune suppressed and surgical patients.
BACKGROUND: Alcohol prep pads, alcohol swabs, and alcohol swabsticks are used to disinfect prior to an injection. They were distributed nationwide to retail pharmacies and are packaged in individual packets and sold in retail pharmacies in a box of 100 packets. The affected Alcohol Prep Pads, Alcohol Swabs and Alcohol Swabsticks can be identified by either “Triad Group,” listed as the manufacturer, or the products are manufactured for a third party and use the names listed below in their packaging: Cardinal Health, PSS Select, VersaPro, Boca/ Ultilet, Moore Medical, Walgreens, CVS, Conzellin.
RECOMMENDATION: If a consumer has any of these types of products in their possession listing “Triad Group” as the manufacturer, they should not use the product and should return it to the place it was purchased for a full refund.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a linl to the Press Release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm239319.htm

Posted 01/06/2011

AngioScore Inc., AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon Catheter OTW 0.018″ Platform – Class I Recall

AUDIENCE: Risk Manager, Cardiology
ISSUE: The device was recalled because of a design defect causing unintended fracture and peeling, and has resulted in peeling of the bond and/or detachment of the distal end of the scoring element. Use of affected devices may lead to retained device fragments or significant arterial injury which may lead to death, or need for additional surgical intervention.
This recall affects 17,682 units distributed from 09/2007 to 11/2010, including the following model part (REF) numbers and includes all sizes and lot codes for each model listed: 2076-4020, 2076-5020, 2076-6020, 2092-6020, 2105-6020.
BACKGROUND: The AngioSculpt PTA Scoring Balloon Catheter OTW 0.018″ Platform is used for dilatation of lesions in the iliac, femoral, ilia-femoral, popliteal, infra popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
RECOMMENDATION: AngioScore Inc. is advising customers to immediately discontinue use of any affected product, examine their inventory, and quarantine all affected product.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the Class I recall notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm239029.htm

Posted 01/05/2011

FDA Medwatch: ev3 NanoCross .014″ OTW PTA Dilatation Catheter: Class I Recall – Potential for cracking or breaking

AUDIENCE: Risk Manager, Surgery
ISSUE: There is potential for cracking or breaking during use. Cracking or breaking of the catheter shaft can result in the inability to inflate or deflate the balloon, and can result in separation of catheter components and potential embolization catheter fragments. Catheter failure may lead to unplanned intravascular or open surgery, significant vasospasm, prolonged tissue ischemia, injury, infarct, bleeding and/or death.
BACKGROUND: The NanoCross 0.014” OTW PTA Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infra-popliteal, and renal arteries. It is also used for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The NanoCross Dilatation Catheter is not an implant. It is removed and discarded after the procedure is completed.
RECOMMENDATION: In a letter dated November 10, 2010, ev3 notified healthcare facilities of the NanoCross .014” OTW PTA Dilatation Catheters voluntary recall. In this letter, it was requested that all affected products are located and removed from use. Detailed steps were also provided about the return and disposition of these affected products to ev3. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable robability that use of these products will cause serious adverse health consequences or death.

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the Recall notice at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm238291.htm

Posted 12/29/2010

FDA – Abbott Glucose Test Strips: Recall – False Low Blood Glucose Results

including Precision Xceed Pro, Precision Xtra, Medisense Optium, Optium, OptiumEZ, ReliOn Ultima

AUDIENCE: Endocrine, Patients, Pharmacy
ISSUE: FDA and Abbott Diabetes Care notified healthcare professionals and patients of a recall of 359 different lots of glucose test strips marketed under the following brand names: Precision Xceed Pro, Precision Xtra, Medisense Optium, Optium, OptiumEZ and ReliOn Ultima. The problem relates to a defect that inhibits sufficient absorption of blood into the test strip. Strips exposed to warm weather or prolonged storage may be more likely to provide a false result. Test strips with lot numbers that have been recalled may give falsely low blood glucose results, which can lead patients to try to raise their blood glucose when it is unnecessary, or to fail to treat elevated blood glucose due to a falsely low reading. Both scenarios pose risks to health.
BACKGROUND: These strips are used with Abbott’s Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, Optium EZ and ReliOn Ultima blood glucose monitoring systems. As many as 359 million strips may be affected by the recall. The test strips, which were manufactured between January and May 2010, are sold both in retail and online settings directly to consumers, but are also used in health care facilities.
RECOMMENDATION: FDA is releasing recommendations for consumers and healthcare professionals. These recommendations explain how to determine whether a particular lot is affected, how to order a free replacement set of strips, and what steps to take in the meantime.
Patients with diabetes should be aware of this problem and take steps to prevent it from affecting their health. Customers can check if they have tests trips from the recalled lots by visiting Abbott’s website to look up their product lot number: http://www.precisionoptiuminfo.com

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including links to the News Release and FDA Questions and Answers, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm237910.htm
Posted 12/22/2010

FDA MedWatch – Fresenius Kabi LLC, Red Blood Cell (RBC) Exchange Sets used on AS104 Blood Cell Separation Devices: Class I Recall

AUDIENCE: Risk Manager, Hematology
ISSUE: Use of the recalled product has led to removal of greater amounts of red blood cells than intended, resulting in hemodilution. 255 units are subject to this recall, including Red Blood Cell (RBC) Set (catalog number 9007601), lot numbers WKT252, YLT061, ZCT011, and ZGT052, manufactured from October 1, 2007 to July 30, 2010.
BACKGROUND: Red Blood Cell (RBC) Set (catalog number 9007601) is used for depletion or exchange of red blood cells during therapeutic apheresis procedures, when blood is removed from the patient and separated into its component parts, on the Fresenius AS 104 Blood Cell Separator Device.
RECOMMENDATION: Customers are instructed to discontinue using, dispensing and distributing the affected product and return product to Fresenius Kabi.

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the Recall Notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm237707.htm

Posted 12/21/2010

November 2010 Safety Labeling Changes: 37 Medical Product Labels with changes to Warnings, Contraindications, Precautions, Adverse Reactions

The MedWatch November 2010 Safety Labeling Changes posting includes 37 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.
The “Summary Page” provides a listing of drug names and safety labeling sections revised: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm233345.htm

Adderall XR (dextroamphetamine mixed salts of a single-entity amphetamine product) Capsules
Anectine (succinylcholine chloride injection, USP)
Arduan (pipecuronium bromide) Injection
Cardizem CD (diltiazem hydrochloride) Capsules and Tablets, Cardizem LA (diltiazem hydrochloride) Extended-Release Tablets
Feraheme (ferumoxytol) Injection
Metopirone (metyrapone USP) 250 mg, Capsules
Metosolv ODT (metoclopramide hydrochloride)
Mivacron (mivacurium chloride) Injection
Nimbex (cisatracurium besylate) Injection
Norcuron (vecuronium bromide) Injection
Nuromax (doxacurium chloride) Injection
Pavulon (pancuronium bromide) Injection
Quelicin (succinylcholine chloride injection, USP)
Rapamune (sirolimus) oral solution and tablets
Raplon (rapacuronium bromide) Injection
Reglan (metoclopramide) tablets, ODT (Orally Disintegrating Tablets), and injection
Revatio (sildenafil) Tablets and Injection
Rifadin (rifampin capsules USP), and Rifadin (rifampin for injection USP) IV
Rifater (rifampin, isoniazid and pyrazinamide) Tablets
Rozerem (ramelteon) Tablets
Tiazac (diltiazem hydrochloride) Extended Release Capsules
Trandate (labetalol hydrochloride) Tablets and Injection
Vfend (voriconazole) Tablets, Injection, and Oral Suspension
Vyvanse (lisdexamfetamine dimesylate) Capsules
Zemuron (rocuronium bromide) Injection

Posted 12/08/2010

Propoxyphene: Withdrawal – Risk of Cardiac Toxicity Sold as Darvon, Darvocet, and generics

AUDIENCE: Pain management, Pharmacy

ISSUE: FDA notified healthcare professionals that Xanodyne Pharmaceuticals has agreed to withdraw propoxyphene, an opioid pain reliever used to treat mild to moderate pain, from the U.S. market at the request of the FDA, due to new data showing that the drug can cause serious toxicity to the heart, even when used at therapeutic doses. FDA concluded that the safety risks of propoxyphene outweigh its benefits for pain relief at recommended doses. FDA requested that the generic manufacturers of propoxyphene-containing products remove their products as well.

BACKGROUND: FDA’s recommendation is based on all available data including data from a new study that evaluated the effects that increasing doses of propoxyphene have on the heart (see Data Summary in Drug Safety Communication). The results of the new study showed that when propoxyphene was taken at therapeutic doses, there were significant changes to the electrical activity of the heart: prolonged PR interval, widened QRS complex and prolonged QT interval. These changes can increase the risk for serious abnormal heart rhythms.

RECOMMENDATION: FDA recommends that healthcare professionals stop prescribing and dispensing propoxyphene-containing products to patients, contact patients currently taking propoxyphene-containing products and ask them to discontinue the drug, inform patients of the risks associated with propoxyphene, and discuss alternative pain management strategies. Patients were advised to dispose of unused propoxyphene in household trash by following the recommendations outlined in the Federal Drug Disposal Guidelines.<http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm226353.htm>

Read the MedWatch safety alert, including links to the Drug Safety Communication, News Release, and supporting documents, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm234389.htm
Posted 11/19/2010

FDA MedWatch – Sigma Spectrum Infusion Pump Model 35700: Class 1 Recall: Risk of Over-Infusion

Audience: Risk Manager, Nursing

Issue: FDA notified healthcare professionals of the class 1 recall of the SIGMA Spectrum Infusion Pump Model 35700. These units may fail suddenly, causing inaccurate flow conditions during use, ranging from back flow to over-infusion, including free flow. The pump does not issue an alarm when this occurs. These conditions could result in serious injury or death.

Background: The recalled pump is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration. The recall was initiated September 15, 2010 and includes serial numbers from 706497 to 724065.

Recommendations: Sigma has instructed healthcare facilities to verify whether the serial numbers for their infusion pumps fall within the range of pumps being recalled and is requiring the return of the recalled devices. Sigma has instructed users to not use the infusion pumps on patient populations, including neonatal patients, where inaccurate flow, ranging from back flow to over-infusion, including free flow, could result in serious adverse health consequences or death.

Read the MedWatch safety alert, including a link to the FDA Recall Notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm233747.htm

Posted 11/15/2010

October 2010 Safety Labeling Changes: 34 Medical Product Labels with changes to Boxed Warnings, Contraindications, Precautions, Adverse Reactions
The MedWatch October 2010 Safety Labeling Changes posting includes 34 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE

The “Summary Page” provides a listing of drug names and safety labeling sections revised:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm230721.htm
Clicking on a drug product name in the Summary View will take you to the “detailed view” page, which identifies safety labeling sections and subsections revised, along with a brief summary of new or modified safety information.
The following drugs had modifications to the BOXED WARNINGS, CONTRAINDICATIONS and WARNINGS sections:

Aldara (imiquimod)
Altace (ramipril)
Depo-Provera Contraceptive injection (medroxyprogesterone acetate)
Enablex (darifenacin)
Fragmin (dalteparin sodium)
Gris-PEG (griseofulvin ultramicrosized)
Invirase (saquinavir mesylate)
Lamictal (lamotrigine)
Lasix (furosemide)
Letairis (ambrisentan)
Myfortic(mycophenolic acid)
Nexavar (sorafenib tosylate)
Nuvigil (armodafinil)
Precedex (dexmedetomidine hydrochloride)
Procardia XL (nifedipine)
Provigil (modafinil)
Rebetol (ribavirin)
Rythmol SR (propafenone hydrochloride) extended-release capsules
Sprycel (dasatinib)

Posted 11/15/2010

FDA MedWatch – Heparin Sodium (B. Braun): Recall – Trace Contaminant

AUDIENCE: Pharmacy, Risk Managers
ISSUE: B. Braun Medical Inc. and FDA notified healthcare professionals of a nationwide recall of certain lots of Heparin Sodium USP Active Pharmaceutical Ingredient (API) sold to B. Braun because testing indicated a trace amount of oversulfated chondroitin sulfate (OSCS) contaminant. These lots were manufactured in 2008 and will be expiring on October 31, 2010 and November 30, 2010.
BACKGROUND: Heparin is a blood thinner used to treat and prevent blood clots.
RECOMMENDATION: Customers who have product from the recalled product lots in their possession should discontinue use immediately. Product lot numbers, expiration dates, and recall instructions are listed in the Press Release.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Read the MedWatch safety alert, including a link to the Press Release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm231739.htm

Posted 11/1/2010

FDA MedWatch – Invirase (saquinavir): Label Change – Risk of Abnormal Heart Rhythm

AUDIENCE: Cardiology, Infectious Disease
ISSUE: FDA notified healthcare professionals of new risk information added to the Warnings and Precautions, Contraindications, and Clinical Pharmacology sections of the antiviral drug Invirase (saquinavir), describing a potential change in the electrical activity of the heart when Invirase is used with another antiviral medication, Norvir (ritonavir). Changes in the electrical activity of the heart may lead to abnormal heart rhythms, known as prolonged QT or PR intervals. A prolonged QT interval can lead to a serious abnormal rhythm called torsades de pointes, which can be fatal. A prolonged PR interval can lead to a serious abnormal rhythm called complete heart block. Torsades de pointes and complete heart block have been reported in patients taking Invirase with Norvir.
BACKGROUND: The medications Invirase and Norvir are given together to treat HIV infection. Norvir must be given at a low dose with Invirase in order to increase the level of Invirase in the body. In February 2010, FDA announced it was reviewing clinical trial data about a potentially serious effect on the heart from the use of Invirase in combination with Norvir.This new information was derived from a clinical study designed to study a drug’s impact on the electrical activity of the heart.
RECOMMENDATION: Patients at particular risk are those with underlying heart conditions or those who have existing heart rate or rhythm problems. An electrocardiogram should be performed prior to initiation of treatment. Physicians consider whether ongoing EKG monitoring is appropriate for patients and when it should be done. The Data Summary in the Drug Safety Communication provides more details.
FDA will require that a Medication Guide be given to patients when picking up a prescription for Invirase. The Medication Guide will include information on the risk of abnormal heart rhythms.
Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm230449.htm

Posted 10/22/2010

FDA MedWatch- Tylenol 8 Hour Caplets 50 Count: Recall Lot number: BCM155

AUDIENCE: Consumer, Pharmacy
ISSUE: McNeil is recalling TYLENOL 8 Hour caplets 50 count bottles to the retail level following a small number of complaints of a musty or moldy odor. The uncharacteristic odor is thought to be caused by the presence of trace amounts of a chemical called 2,4,6-tribromoanisole.
BACKGROUND: This voluntary action is being taken as a precaution and the risk of adverse medical events is remote. To date, observed events reported to McNeil were temporary and non-serious. The product lot number for the recalled product can be found on the side of the bottle label.
RECOMMENDATION: Consumers should stop using the affected product and contact McNeil Consumer Healthcare, either at www.tylenol.com or by calling 1-888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time) for instructions about receiving a refund or product coupon. Consumers who have medical concerns or questions should contact their healthcare provider.
Read the MedWatch safety alert, including a link to the company Press Release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm230218.htm

Posted 10/20/2010

FDA MedWatch – Excelsior Medical 5 ml Fill in 6 cc Prefilled Saline Flush Syringes: Recall – Potential Loss of Sterility

AUDIENCE: Risk Manager
ISSUE: Routine internal testing conducted on this product found that some of these syringes may leak and lose sterility. This recall pertains only to syringes with the following product code numbers: E0100-50, 10056-1000, 10056-240, 14056-240, 910056-1000, and S5. Exposure to syringes with a sterility issue could result in systemic infection, which may lead to serious injury and/or death.
BACKGROUND: The Excelsior Disposable 5ml fill in 6 cc prefilled saline flush syringes are intended for the flushing of venous access devices and IV tubing.
RECOMMENDATION: Consumers who have 5ml fill in 6 cc saline pre-filled syringes manufactured by Excelsior Medical should immediately discontinue using these syringes and return them to the point of purchase.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the company press release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm229781.htm

Posted 10/18/2010

FDA MedWatch- CareFusion Corporation Alaris PC Units (Model 8015): Recall – Potential for Delay or Interruption of Therapy

AUDIENCE: Risk Manager
ISSUE: Under certain wireless network conditions, a communication error can occur, which freezes the PC Unit screen. This error may result in a delay of therapy and inability to make programming changes to current infusions.
If the communication error occurs during infusion, infusion continues on all channels, as originally programmed, but cannot be modified. When this error occurs, stopping the infusion to make any modification or programming changes causes the PC unit to shut down resulting in a delay or interruption in therapy. This could lead to serious injury and/or death. These devices were manufactured from December 20, 2008 through September 8, 2009 and distributed from December 20, 2008 through June 28, 2010.
BACKGROUND: Electronic infusion pumps deliver controlled amounts of medications or other fluids to patients through an intravenous (IV), intra-arterial (IA), epidural, and other acceptable routes of administration.
RECOMMENDATION: If users experience the problem, they are to remove the device from service and contact the CareFusion Recall Center immediately. The corrective action will require a hardware update to all affected units. CareFusion does not require that the devices be returned.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of this product to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the FDA recall notice, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm229767.htm

Posted 10/18/2010

FDA Medwatch – Chelation Products: Unapproved Over-the-Counter Drugs – Consumer Warning

AUDIENCE: Consumer
ISSUE: FDA advised consumers to avoid “chelation” products that are marketed over-the-counter (OTC) to prevent or treat diseases. There are serious safety issues associated with chelation products. Depending on the condition, when relying on unproven OTC chelation products to treat serious conditions, patients may delay seeking effective medical care. Even when used under medical supervision, these products can cause serious harm, including dehydration, kidney failure, and death.
BACKGROUND: Chelation involves the use of certain chemicals to remove heavy metals from the body. Although some of the products are marketed as dietary supplements, they are unapproved drugs because they claim to treat, mitigate, prevent, or diagnose disease. FDA has never approved any chelation product for OTC use for any health condition. All FDA-approved chelation products require a prescription because they can only be used safely under the supervision of healthcare practitioner.
RECOMMENDATION: The agency advises consumers to avoid non-prescription products offered for chelation or detoxification.
Read the MedWatch safety alert, including links to the FDA Press Release, Questions and Answers, and Consumer Update, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm229454.htm

Posted 10/18/2010

FDA MedWatch – Bisphosphonates (Osteoporosis Drugs): Label Change – Atypical Fractures Update

including Fosamax, Fosamax Plus D, Actonel, Actonel with Calcium, Boniva, Atelvia, and Reclast
AUDIENCE: Patient, Family Practice, Geriatric
ISSUE: FDA is updating the public regarding information previously communicated describing the risk of atypical fractures of the thigh, known as subtrochanteric and diaphyseal femur fractures, in patients who take bisphosphonates for osteoporosis. This information will be added to the Warnings and Precautions section of the labels approved to treat osteoporosis, including Fosamax, Fosamax Plus D, Actonel, Actonel with Calcium, Boniva, Atelvia, and Reclast (and their generic products). A Medication Guide will also be required to be given to patients when they pick up their bisphosphonate prescription.
BACKGROUND: Atypical subtrochanteric femur fractures are fractures in the bone just below the hip joint. Diaphyseal femur fractures occur in the long part of the thigh bone. These fractures are very uncommon and appear to account for less than 1% of all hip and femur fractures overall. Although it is not clear if bisphosphonates are the cause, these unusual femur fractures have been predominantly reported in patients taking bisphosphonates.
RECOMMENDATIONS: Patients should continue to take their medication unless told to stop by their healthcare professional. FDA recommends that healthcare professionals should discontinue potent antiresorptive medications (including bisphosphonates) in patients who have evidence of a femoral shaft fracture. See the FDA Drug Safety Communication below for additional information.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm229244.htm
Tell us how we are doing:
http://survey.foreseeresults.com/survey/display?cid=d509U9xg0gZVxkMRcoMsQg==&sid=link&cpp[date]=10_13_2010_1445&cpp[type]=S

Posted 10/15/2010

FDA MedWatch – Meridia (sibutramine): Market Withdrawal Due to Risk of Serious Cardiovascular Events

AUDIENCE: Primary Care, Consumers
ISSUE: Abbott Laboratories and FDA notified healthcare professionals and patients about the voluntary withdraw of Meridia (sibutramine), an obesity drug, from the U.S. market because of clinical trial data indicating an increased risk of heart attack and stroke.
BACKGROUND: Meridia was approved November 1997 for weight loss and maintenance of weight loss in obese people, as well as in certain overweight people with other risks for heart disease. The approval was based on clinical data showing that more people receiving sibutramine lost at least 5 percent of their body weight than people on placebo who relied on diet and exercise alone. FDA has now requested market withdrawal after reviewing data from the Sibutramine Cardiovascular Outcomes Trial (SCOUT). SCOUT is part of a postmarket requirement to look at cardiovascular safety of sibutramine after the European approval of the drug. The trial demonstrated a 16 percent increase in the risk of serious heart events, including non-fatal heart attack, non-fatal stroke, the need to be resuscitated once the heart stopped, and death, in a group of patients given sibutramine compared with another given placebo. There was a small difference in weight loss between the placebo group and the group that received sibutramine.
RECOMMENDATION: Physicians are advised to stop prescribing Meridia to their patients, and patients should stop taking this medication. Patients should talk to their health care provider about alternative weight loss and weight loss maintenance programs.
Read the MedWatch safety alert, including links to the FDA Drug Safety Communication, Q&As, and News Release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm228830.htm

Posted 10/08/2010

______________________________________________________________

FDA MedWatch – Epogen and Procrit (epoetin alfa): Recall – Particulate Matter in Vials
Epogen and Procrit (epoetin alfa): Recall – Particulate Matter in Vials
*AUDIENCE*: Risk Manager, Oncology, Nephrology
*ISSUE*: Amgen and FDA notified healthcare professionals that certain lots of Epogen and Procrit (Epoetin alfa) vials are being recalled as a precaution, because the vials may contain extremely thin glass flakes (lamellae) that are barely visible. The potential serious adverse events resulting from the use of a sterile injectable product with particulates by the intravenous route include embolic, thrombotic and other vascular events (e.g., phlebitis), and by the subcutaneous route include foreign body granuloma, local injection site reactions, and increased immunogenicity.
*BACKGROUND*: The products are indicated for the treatment of anemia related to HIV therapy, chronic renal failure, and chemotherapy. The lamellae result from the interaction of the formulation with glass vials over the shelf life of the product. The affected product lot numbers and expiration dates are included in the table in the firm press release, linked below.
*RECOMMENDATIONS*: Amgen has initiated recall letters which include instructions to return the referenced product to the returned goods service provider.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to 1-800-77-AMGEN or to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

* Complete and submit the report Online: www.fda.gov/MedWatch/report.htm [ http://www.fda.gov/MedWatch/report.htm ]
* Download form [ http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm ] or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the firm Press Release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm227225.htm
Posted 09/27/2010

FDA MedWatch – Avandia (rosiglitazone): REMS – Risk of Cardiovascular Events

AUDIENCE: Endocrinology, Cardiology
ISSUE: FDA notified healthcare professionals and patients that it will significantly restrict the use of the diabetes drug Avandia (rosiglitazone) to patients with Type 2 diabetes who cannot control their diabetes on other medications. These new restrictions are in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia.
BACKGROUND: Avandia is in a class of drugs known as thiazolidinediones, or TZDs. It is intended to be used in conjunction with diet and exercise to improve glucose (blood sugar) control in patients with Type 2 diabetes mellitus. Rosiglitazone also is available in combination with other diabetes medications, metformin under the brand name Avandamet or glimepiride under the brand name Avandaryl.
RECOMMENDATION: FDA will require that GSK develop a restricted access program for Avandia under a risk evaluation and mitigation strategy, or REMS. Under the REMS, Avandia will be available to new patients only if they are unable to achieve glucose control on other medications and are unable to take Actos (pioglitazone), the only other drug in this class. Current users of Avandia who are benefiting from the drug will be able to continue using the medication if they choose to do so.
Doctors will have to attest to and document their patients’ eligibility; patients will have to review statements describing the cardiovascular safety concerns associated with this drug and acknowledge they understand the risks. The agency anticipates that the REMS will limit use of Avandia significantly.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including links to the FDA News Release, Q&As, and related information, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm226994.htm

Posted 09/23/2010

FDA MedWatch – Actos (pioglitazone): Ongoing Safety Review – Potential Increased Risk of Bladder Cancer

AUDIENCE: Endocrinology, Family Practice, Urology
ISSUE: FDA notified healthcare professionals and patients that the Agency is reviewing data from an ongoing, ten-year epidemiological study designed to evaluate whether Actos (pioglitazone) is associated with an increased risk of bladder cancer. Findings from studies in animals and humans suggest this is a potential safety risk that needs further study. At this time, FDA has not concluded that Actos increases the risk of bladder cancer. Its review is ongoing, and the Agency will update the public when it has additional information.
BACKGROUND: The drug manufacturer, Takeda, conducted a planned analysis of the study data at the five-year mark, and submitted their results to FDA. Overall, there was no statistically significant association between Actos exposure and bladder cancer risk. However, further analyses were also performed looking at how long patients were on Actos and the total amount of the drug they received during that time. An increased risk of bladder cancer was observed among patients with the longest exposure to Actos, as well as in those exposed to the highest cumulative dose of Actos.
RECOMMENDATIONS: Healthcare professionals should continue to follow the recommendations in the drug label when prescribing Actos. Patients should continue taking Actos unless told otherwise by their healthcare professional. Patients who are concerned about the possible risks associated with using Actos should talk to their healthcare professional.
Additional Information for Patients, Information for Healthcare Professionals, and a Data Summary are provided in the Drug Safety Communication.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including links to the Drug Safety Communication and FDA News Release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm226257.htm

Posted 09/17/2010

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FDA MedWatch – BagEasy Manual Resuscitation Devices by Westmed, Inc.: Class 1 Recall

AUDIENCE: Risk Manager, Emergency Medicine
ISSUE: Westmed, Inc. is initiating a nationwide recall of 24,384 units of BagEasy Manual Resuscitation Devices. The BagEasy device have been found to have a potential for disconnection at the retention ring of the patient port manifold. Disconnection causes the unit to be inoperable, which potentially could result in treatment delays while another unit is obtained or technician switches to a different method of resuscitation.
BACKGROUND: Westmed has become aware of a potential for disconnection at the patient port retention ring assembly of the BagEasy manual resuscitation device after receiving reports from three separate facilities regarding units disconnecting during setup or use. The BagEasy manual resuscitation device was distributed to other medical device distribution companies as well as directly to hospitals and other treatment facilities.
RECOMMENDATIONS: Consumers with questions may contact the company at 1-800-975-7987 and arrange for return of all recalled products. For the affected part numbers and lot numbers please see the firm press release. Healthcare professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the complete MedWatch Safety Alert at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm226014.htm

Posted 09/16/2010

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FDA MedWatch – August 2010 Drug Safety Labeling Changes: 24 Medical Product Labels with changes to Warnings, Contraindications, Precautions, Adverse Reactions

The MedWatch August 2010 Drug Safety Labeling Changes posting includes 24 products with safety labeling changes to the following sections: CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.
The “Summary Page” provides a listing of drug names and safety labeling sections revised:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm225299.htm
Clicking on a drug product name in the Summary View will take you to the “detailed view” page, which identifies safety labeling sections and subsections revised, along with a brief summary of new or modified safety information.
The following drugs had modifications to the CONTRAINDICATIONS and WARNINGS sections:

Advil Allergy Sinus (ibuprofen, chlorpheniramine maleate, and pseudoephedrine) Aleve (naproxen sodium) Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate)
Biltricide (praziquantel)
Childrens Advil Cold (ibuprofen and pseudoephedrine)
Cubicin (daptomycin)
Exelon Patch (rivastigmine)
Flagyl (metronidazole)
Heparin Sodium in the 5% Dextrose injection and in the 0.9% Sodium Chloride injection
Meridia (sibutramine hydrochloride)
Plavix (clopidogrel bisulfate)
Risperdal (risperidone)

Posted 09/16/2010

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FDA MedWatch – Valcyte (valganciclovir hydrochloride) Label Change: Possible overdose in pediatric patients

AUDIENCE: Transplantation, Infectious Disease, Pediatrics, Pharmacy
ISSUE: FDA is notifying healthcare professionals of new pediatric dosing recommendations for Valcyte (valganciclovir hydrochloride) oral tablets and oral solution. FDA has determined that adding an upper limit of 150 mL/min/1.73 m2 to the creatinine clearance calculated using the Schwartz formula for the determination of pediatric doses can help prevent the potential for Valcyte overdosing in children with low body weight, low body surface area, and below normal serum creatinine.
BACKGROUND: Valganciclovir is an antiviral medication that can be effective for the prevention of cytomegalovirus (CMV) disease in children 4 months to 16 years of age who have undergone a kidney or heart transplant. Cytomegalovirus is a member of a group of herpes-type viruses that can cause disease in different parts of the body.
RECOMMENDATION: If the calculated pediatric dose of Valcyte exceeds 900 mg, a dose of 900 mg should be administered to the child. The dosing calculation can be found in the Drug Safety Communication. Be aware of possible valganciclovir overdose in pediatric patients with low body weight, low body surface area, or below normal serum creatinine. Report adverse events involving Valcyte to MedWatch:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Read the complete MedWatch 2010 Safety summary, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm225888.htm

Posted 09/15/2010

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FDA MedWatch – Fresenius Urgent Recall for AC Power Cords

Fresenius Medical Care is initiating this recall for certain Fresenius devices that may have a defective plug, which is part of an AC power cord manufactured by Electri‐Cord Manufacturing Company. This alert is being issued in response to a FDA alert regarding customer reports of sparking, charring and fires of similarly designed AC power cores in non‐dialysis products manufactured by other companies. Fresenius is advising all customers to assess whether their devices have the affected Electri‐Cord AC power cords and inspect the cord plugs for evidence of damage (charring, discoloration of the plastic, broken or loose prongs).
Full Document/Alert

Posted 09/14/2010

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FDA MedWatch – Gadolinium-based Contrast Agents: Class Labeling Change – Risk of Nephrogenic Systemic Fibrosis

Ablavar (gadofosveset trisodium), Eovist (gadoxetate disodium), Magnevist (gadopentetate dimeglumine), Multihance (gadobenate dimeglumine), Omniscan (gadodiamide), Optimark (gadoversetamide injection), Prohance (gadoteridol)
AUDIENCE: Radiology, Nephrology, Dermatology
ISSUE: FDA is requiring changes in the professional labeling for gadolinium-based contrast agents (GBCAs) to minimize the risk of nephrogenic systemic fibrosis (NSF), a rare, but serious, condition associated with the use of GBCAs in certain patients with kidney dysfunction. NSF has not been reported in patients with normal kidney function. Patients at greatest risk for developing NSF after receiving GBCAs are those with impaired elimination of the drug, including patients with acute kidney injury or chronic, severe kidney disease.
BACKGROUND: GBCAs are intravenous drugs used in diagnostic imaging procedures to enhance the quality of magnetic resonance imaging or magnetic resonance angiography.
RECOMMENDATION: Healthcare professionals should screen patients prior to administration of a GBCA to identify those with acute kidney injury or chronic, severe, kidney disease. See the Drug Safety Communication for the complete list of recommendations to healthcare professionals and patients.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm225375.htm

Posted 09/09/2010

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FDA MedWatch – Tygacil (tigecycline): Label Change – Increased Mortality Risk

AUDIENCE: Infectious Disease, Critical Care Medicine, Internal Medicine
ISSUE: FDA reminded healthcare professionals of an increased mortality risk associated with the use of the intravenous antibacterial Tygacil (tigecycline) compared to that of other drugs used to treat a variety of serious infections. The increased risk was seen most clearly in patients treated for hospital-acquired pneumonia, especially ventilator-associated pneumonia, but was also seen in patients with complicated skin and skin structure infections, complicated intra-abdominal infections and diabetic foot infections. FDA has updated sections of the Tygacil drug label to include information regarding increased mortality risk of Tygacil.
BACKGROUND: Tygacil is approved by FDA for the treatment of complicated skin and skin structure infections, complicated intra-abdominal infections, and community acquired pneumonia. Tygacil is not approved for the treatment of hospital-acquired pneumonia (including ventilator-associated pneumonia) or diabetic foot infection. The increased risk was determined using a pooled analysis of clinical trials. See the Data Summary section of the FDA Drug Safety Communication for additional details.
RECOMMENDATION: Alternatives to Tygacil should be considered in patients with severe infections. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of this product to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the Medwatch safety alert, including a link to the FDA Drug Safety Communication, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm224626.htm

Posted 09/1/2010

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FDA MedWatch – Fingerstick Devices to Obtain Blood Specimens: Initial Communication – Risk of Transmitting Bloodborne Pathogens

Reusable fingerstick (blood lancing) devices and point of care (POC) blood testing devices (e.g., blood glucose meters, PT/INR anticoagulation meters, cholesterol testing devices)
AUDIENCE: Primary Care, Nursing, Laboratory
ISSUE: FDA and CDC have noted a progressive increase in the reports of bloodborne infection transmission over the past 10 to 15 years (primarily hepatitis B virus), resulting from the shared use of fingerstick and point-of-care [POC] blood testing devices.
Fingerstick and POC blood testing devices used on more than one patient may not be safe for several reasons. Improper use or device malfunction can lead to the use of the contaminated lancet blade on more than one patient. It is difficult for healthcare staff to ensure that all blood has been removed from POC blood testing devices and the reusable portions of the fingerstick device. If POC blood testing devices are used on multiple patients and are not cleaned and disinfected correctly and thoroughly between each patient, contaminated blood left on them could result in bloodborne pathogen transmission among patients.
BACKGROUND: Fingerstick devices are instruments equipped with a lancet. These devices are used for making skin punctures to obtain small blood specimens which are tested for blood glucose, hemoglobin, and other blood components. Some fingerstick devices are packaged with POC blood testing devices, such as blood glucose meters and PT/INR anticoagulation meters, while other fingerstick devices and lancet blades are sold separately.
RECOMMENDATION: Fingerstick devices should never be used for more than one person. Whenever possible, POC blood testing devices, such as blood glucose meters and PT/INR anticoagulation meters, should be used only on one patient and not shared. If dedicating POC blood testing devices to a single patient is not possible, the devices should be properly cleaned and disinfected after every use as described in the device labeling.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Read the MedWatch safety alert, including links to the FDA Initial Communication and CDC web pages regarding use of fingerstick devices, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm224135.htm

Posted 08/26/2010

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FDA MedWatch – Midodrine hydrochloride: FDA Proposes Withdrawal of Low Blood Pressure Drug

AUDIENCE: Cardiology and Nephrology
ISSUE: FDA proposed to withdraw approval of the drug midodrine hydrochloride, used to treat the low blood pressure condition, orthostatic hypotension, because required post-approval studies that verify the clinical benefit of the drug have not been done. To date, neither the original manufacturer nor any generic manufacturer has demonstrated the drug’s clinical benefit, for example, by showing that use of the drug improved a patient’s ability to perform life activities.
BACKGROUND: The drug, marketed as ProAmatine by Shire Development Inc. and as a generic by others, was approved in 1996 under the FDA’s accelerated approval regulations for drugs that treat serious or life-threatening diseases. That approval required that the manufacturer verify clinical benefit to patients through post-approval studies.
RECOMMENDATION: Patients who currently take this medication should not stop taking it and should consult their health care professional about other treatment options.
Read the MedWatch safety alert, including a link to the FDA Press Release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm222640.htm

Posted 08/17/2010

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FDA MedWatch – August 2010 FDA Patient Safety News now available
FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals. It covers significant safety alerts, recalls, new product approvals, and offers important tips on protecting patients. Read the complete stories and watch or download the video program at www.fda.gov/psn. You may have already received notification of some of these safety issues through the MedWatch E-list. However, many of these PSN stories contain video footage and demonstrations that may be especially useful to clinicians and educators in healthcare facilities and academic institutions.

Stories in the August 2010 edition include:

Warning on Proton Pump Inhibitors and Fracture Risk
Prescribers should consider whether a lower dose or shorter duration of PPI therapy might be possible…

Lifeline and ReviveR AED Battery Packs Recalled
Affected battery packs may cause the AED to inappropriately cancel the charge and be unable to deliver therapy…

Update on Counterfeit Polypropylene Mesh
FDA testing has now found that the counterfeit samples are not sterile, although they are labeled as sterile…

Thrombosis with Off-Label Promacta Use
Promacta is not indicated for treating thrombocytopenia in patients with chronic liver disease…

Severe Liver Injury with Orlistat (Xenical, Alli)
Rare cases of severe liver injury in patients taking this weight loss drug…

Dosing Errors with Certain Oral Syringes
Confusion over what part of the syringe plunger to use when measuring the dose…

Reporting Adverse Events to MedWatch
FDA’s MedWatch program relies on healthcare professionals and consumers to report serious problems with medical products…

Help FDA Stop “Bad Ads”
FDA encourages healthcare professionals to recognize misleading or inaccurate promotion by drug companies and report it to the agency…

Posted 08/09/2010

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Letter to Infection Control Practitioners Regarding Positive Displacement Needleless Connectors

Dear Infection Control Professional,
The Food and Drug Administration is requiring nine companies to conduct a postmarket surveillance study on positive displacement needleless connectors to assess whether they may be associated with a higher rate of device-associated bloodstream infections (BSI) than other types of needleless connectors, and to assess the factors that may contribute to a possible increased risk.
Read more…

Posted 07/30/2010

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FDA MedWatch – June 2010 Drug Safety Labeling Changes: 28 Medical Product Labels with changes to Boxed Warning, Warnings, Contraindications, Precautions, Adverse Reactions

The MedWatch June 2010 Drug Safety Labeling Changes posting includes 28 products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.
The “Summary Page” provides a listing of drug names and safety labeling sections revised:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm218813.htm
Clicking on a drug product name in the Summary View will take you to the “detailed view” page, which identifies safety labeling sections and subsections revised, along with a brief summary of new or modified safety information.
The following drugs had modifications to the BOXED WARNINGS, CONTRAINDICATIONS and WARNINGS sections

Advair Diskus (fluticasone propionate and salmeterol xinafoate) inhalation powder
Advair HFA Inhalation Aerosol (fluticasone propionate and salmeterol xinafoate)
Avodart (dutasteride) soft gelatin capsules
Brovana Inhalation Solution (arformoterol tartrate)
Ceftriaxone for Injection and Dextrose Injection in the Duplex Container
Copegus (ribavirin) tablets
Foradil Aerolizer (formoterol fumarate inhalation powder)
Heparin Sodium injection
Hycamtin (topotecan hydrochloride) capsules
Kaletra (lopinavir/ritonavir) tablets and oral solution
Novantrone (mitoxantrone HCl) injection
Ovidrel (choriogonadotropin alfa injection) prefilled syringe
Rybix ODT (tramadol hydrochloride) orally disintegrating tablet
Serevent Diskus (salmeterol xinafoate) inhalation powder
Solu-Medrol (methylprednisolone sodium succinate) for injection
Symbicort Inhalation Aerosol (budesonide and formoterol)

Posted 07/15/2010

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FDA MedWatch – Angiotensin Receptor Blockers (ARBs): Ongoing Safety Review for Cancer Risk

AUDIENCE: Cardiology, Oncology, Family Practice
ISSUE: A recently published study – a meta-analysis combining cancer-related findings from several clinical trials – suggested use of ARBs may be associated with a small increased risk of cancer.
BACKGROUND: ARBs are used in patients with high blood pressure and other conditions. Brand names include Atacand, Avapro, Benicar, Cozaar, Diovan, Micardis, and Teveten.
The meta-analysis included data from over 1,000 patients in several long-term, randomized, controlled clinical trials evaluating ARBs for which adverse events related to cancer were captured during the study. The mean duration of follow-up ranged from 1.7 to 4.8 years.
The study reported the frequencies of new cancer occurrence to be 7.2% for patients receiving ARBs compared to 6.0% for those not receiving ARBs (risk ratio = 1.08, 95% Confidence Interval: 1.01-1.15). No statistically significant difference in cancer deaths was noted.
RECOMMENDATION: FDA has not concluded that ARBs increase the risk of cancer. The Agency is reviewing information related to this safety concern and will update the public when additional information is available. FDA believes the benefits of ARBs continue to outweigh their potential risks.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Online: www.fda.gov/MedWatch/report.htm
Phone: 1-800-332-1088
Mail: return the postage-paid FDA form 3500, which may be downloaded from the MedWatch “Download Forms” page, to address on the pre-addressed form
Fax: 1-800-FDA-0178

Read the MedWatch safety alert page, including a link to the Drug Safety Communication, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm219185.htm

Posted 07/15/2010

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FDA MedWatch – Arava (leflunomide): Boxed Warning- Risk of Severe Liver Injury

AUDIENCE: Rheumatology, Family Practice
ISSUE: FDA is adding information on severe liver injury to the Boxed Warning of Arava (leflunomide) a drug used to treat rheumatoid arthritis – to highlight the risk of severe liver injury in patients using this drug and how this risk may be reduced. FDA previously required a Boxed Warning stating that leflunomide was contraindicated in pregnant women, or women of childbearing potential who were not using reliable contraception.
BACKGROUND: The decision to add information on severe liver injury to the Boxed Warning was based on FDA’s review of adverse event reports which identified 49 cases of severe liver injury, including 14 cases of fatal liver failure, between August 2002 and May 2009. In this review, the greatest risk for liver injury was seen in patients taking other drugs known to cause liver injury, and patients with pre-existing liver disease.
RECOMMENDATIONS: The information on severe liver injury being added to the Boxed Warning states:

Patients with pre-existing liver disease should not receive leflunomide.
Patients with elevated liver enzymes (ALT greater than two times the upper limit of normal) should not receive leflunomide.
Caution should be used in patients who are taking other drugs that can cause liver injury.
Liver enzymes should be monitored at least monthly for three months after starting leflunomide and at least quarterly thereafter.
If the ALT rises to greater than two times the upper limit of normal while the patient is on leflunomide – leflunomide should be stopped, cholestryamine washout begun to speed the removal of leflunomide from the body and follow-up liver function tests conducted at least weekly until the ALT value is within normal range.

Read the MedWatch safety alert, including a link to the Drug Safety Communication, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm218912.htm

Posted 07/13/2010

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FDA MedWatch – Qualaquin (quinine sulfate): New Risk Evaluation and Mitigation Strategy – Risk of serious hematological reactions

Audience: Primary Care, Infectious Disease
ISSUE: Due to continued reports of serious side effects in patients using Qualaquin “off-label” for night time leg cramps, FDA has approved a risk management plan to warn against the use of this drug for such unapproved uses. Qualaquin should not be used for night time leg cramps. Qualaquin use may result in serious and life-threatening hematological reactions, including serious bleeding due to thrombocytopenia, and hemolytic-uremic syndrome/ thrombotic thrombocytopenic purpura, which in some cases may result in permanent kidney damage. In some patients, adverse reactions result in hospitalization and death.
BACKGROUND: Qualaquin is only FDA-approved for the treatment of uncomplicated malaria caused by the parasite Plasmodium falciparum, primarily in travelers returning from malaria-endemic areas. However, the majority of Qualaquin’s use in the United States is for the treatment or prevention of night time leg cramps.The product labeling states that the risks associated with the use of Qualaquin in the absence of evidence of its effectiveness for treatment or prevention of nocturnal leg cramps outweigh any potential benefits.
The risk management plan (REMS) requires that patients be given a Medication Guide explaining what this medication is and is not approved for, as well as the potential side effects of this drug. In addition, the REMS requires that the manufacturer issue a Dear Health Care Provider Letter warning of the risk of serious and life-threatening hematologic reactions.
A data summary of adverse event reports received by FDA from April 2005 to October 2008 is provided in the Drug Safety Communication below.
RECOMMENDATION: Healthcare professionals should discuss with patients the warning signs of thrombocytopenia, such as easy bruising, severe nose bleeds, blood in the urine or stool, bleeding gums, and the appearance of unusual purple, brown, or red spots on the skin. Patients are encouraged to read the Medication Guide given to them at the pharmacy before starting Qualaquin and each time they get a refill.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

- Online: www.fda.gov/MedWatch/report.htm
- Phone: 1-800-332-1088
- Mail: return the postage-paid FDA form 3500, which may be downloaded from the MedWatch “Download Forms” page, to address on the pre-addressed form
- Fax: 1-800-FDA-0178

Read the complete MedWatch 2010 Safety Summary, including links to the Drug Safety Communication with additional instructions for clinicians and for patients, a data summary, a Consumer update article and FDA news release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm218424.htm

Posted 07/08/2010

FDA MedWatch – July 2010 FDA Patient Safety News now available

New Cellular Immunotherapy for Advanced Prostate Cancer
Provenge is designed to stimulate the patient’s immune system to respond against the cancer…

Warning on Liver Injury with Propylthiouracil
New boxed warning highlights that propylthiouracil should be reserved for patients who cannot tolerate methimazole, radioactive iodine or surgery…

Medication Guide Required for Vivitrol
New medication guide, which highlights potential side effects and what to avoid during treatment, should be given to patients before each Vivitrol injection…

Certain AQUA+FLEX Humidifiers Recalled
The humidifier’s flex tube connector could become disconnected from the endotracheal tube…

Recall of Shiley Cuffed Tracheostomy Tubes
A leak in the pilot balloon assembly may cause the cuff to lose air, which may compromise the patient’s ventilation…

Using External Infusion Pumps Safely
Recommendations for clinicians to reduce infusion pump-related risks…

Parent Errors in Measuring Children’s Doses
The Institute for Safe Medication Practices reported on a study that showed parents made more errors with dosing cups than with other measuring devices…

Warning on Swallowing Benadryl Topical Gel
To help prevent mix-ups, the front of the bottle and bottle cap now says “For Skin Use Only”…

Warning about Lipodissolve Products
FDA has not approved any injectable drug to eliminate fat, and the safety of these products, used alone or in combination is unknown…

Posted 07/06/2010

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LIFEPAK 20 and LIFEPAK 20e External Defibrillator/Monitors by Physio-Control Inc.:

Class I Recall Due To Power Supply Failure

Audience: Emergency Medicine, Cardiology, Risk Manager
ISSUE: A failure on the power supply assembly can result in either “No DC power” or “No DC or AC power”. A failure of DC (battery) power can result in the inability to deliver defibrillation therapy if the device will not turn on using DC (battery) power and no AC (line) power is available.
BACKGROUND: The LIFEPAK 20 and LIFEPAK 20e defibrillator/monitor is designed for use by trained medical personnel in hospitals and clinic settings to monitor patient heart rhythms and to treat patients experiencing cardiac arrest. Approximately 42,943 devices were distributed worldwide between September 16, 2002 and September 27, 2007. These devices were manufactured from July 31, 2002 to September 19, 2007.
RECOMMENDATION: All affected power supplies will be updated. Customers are advised to keep the defibrillators in service and follow recommended daily Operator Checklist steps while service updates are scheduled. See Recall Notice for contact information.
Read the MedWatch safety alert, including a link to the FDA Class I Recall Notice, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm217980.htm

Posted 07/02/2010

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Tamiflu: Counterfeit Product Sold on Internet

Fraudulent product is dangerous to patients allergic to penicillin

Audience: Consumers, Pharmacists
Issue: FDA notified consumers and healthcare professionals about a potentially harmful product represented as “Generic Tamiflu” sold over the Internet. FDA tests revealed that the fraudulent product does not contain Tamiflu’s active ingredient, oseltamivir, but cloxacillin, an ingredient in the same class of antibiotics as penicillin. Patients who are allergic to penicillin products are at risk of experiencing similar reactions from cloxacillin. This includes a sudden, potentially life-threatening reaction called anaphylaxis, with symptoms that include difficulty breathing, chest tightness, swelling of the throat or tongue, hives, dizziness, loss of consciousness, or a rapid or weak pulse.
Background: The FDA bought the fraudulent “Generic Tamiflu” without a prescription from a website claiming to be an online drugstore that is no longer operational. The fraudulent version is likely to be found for sale on other websites, however. Legitimate internet pharmacies are licensed by the appropriate U.S. Board of Pharmacy and follow the applicable laws and regulations. Consumers can also be confident that the National Association of Boards of Pharmacy Verified Internet Pharmacy Sites Seal, also known as VIPPS Seal, gives a seal of approval to pharmacy sites that apply and meet state licensure requirements. Legitimate pharmacies that carry the VIPPS seal are listed at www.vipps.info
Recommendation: The FDA advises anyone possessing or encountering any of these fraudulent Tamiflu drugs not to use them and to contact the FDA’s Office of Criminal Investigations by visiting the OCI website (http://www.fda.gov/OCI).
Consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Online: www.fda.gov/MedWatch/report.htm
Phone: 1-800-332-1088
Mail: return the postage-paid FDA form 3500, which may be downloaded from the MedWatch “Download Forms” page, to address on the pre-addressed form
Fax: 1-800-FDA-0178

Read the complete MedWatch 2010 Safety summary, including a link to the FDA news release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm216183.htm

Posted 06/18/2010

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FDA MedWatch – The MedWatch May 2010 Drug Safety Labeling Changes posting includes 23 products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.
The “Summary Page” provides a listing of drug names and safety labeling sections revised:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm214902.htm
Clicking on a drug product name in the Summary View will take you to the “detailed view” page, which identifies safety labeling sections and subsections revised, along with a brief summary of new or modified safety information.
The following drugs had modifications to the CONTRAINDICATIONS and WARNINGS sections:

Camptosar (irinotecan HCl)
Cervidil (dinoprostone)
Droxia and Hydrea (hydroxyurea)
NovoLog Mix 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart [rDNA origin])
Parnate (tranylcypromine sulfate)
PrandiMet (repaglinide/metformin HCl fixed-dose combination)
Remeron (mirtazapine) tablets and RemeronSolTab (mirtazapine)
Selzentry (maraviroc)
Tekturna HCT (aliskiren/hydrochlorothiazide)
Vaprisol (conivaptan)
Zyprexa (olanzapine)

Posted 06/15/2010

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FDA MedWatch – Benicar (olmesartan): Ongoing Safety Review

*Audience*: Cardiology, Internal Medicine
*ISSUE*: FDA is evaluating data from two clinical trials in which patients with type 2 diabetes taking the blood pressure medication, Benicar (olmesartan), an angiotensin II receptor blocker, had a higher rate of death from a cardiovascular cause compared to patients taking a placebo. FDA’s review is ongoing and the Agency has not concluded that Benicar increases the risk of death. FDA currently believes that the benefits of Benicar in patients with high blood pressure continue to outweigh its potential risks.
*BACKGROUND*: The Agency plans to review the primary data from the two studies of concern, ROADMAP and ORIENT, and is considering additional ways to assess the cardiovascular effects of Benicar. ROADMAP and ORIENT are both long-term clinical trials. In both trials, patients with type 2 diabetes were given either Benicar or placebo to determine if treatment with Benicar would slow the progression of kidney disease. An unexpected finding observed in both trials was a greater number of deaths from a cardiovascular cause (heart attack, sudden death, or stroke) in the Benicar-treated patients compared to placebo.
*RECOMMENDATION*: Follow the recommendations in the drug label when prescribing Benicar. Additional Information for Patients, for Healthcare Professionals and a Data Summary are provided in the Drug Safety Communication below. Additional information about ROADMAP and ORIENT can be found at clinicaltrials.gov [http://www.clinicaltrials.gov].
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
* Online: www.fda.gov/MedWatch/report.htm [https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm]
* Phone: 1-800-332-1088
*Mail: return the postage-paid FDA form 3500, which may be downloaded from the MedWatch “Download Forms
[http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm ]” page, to address on the pre-addressed form
* Fax: 1-800-FDA-0178
Read the complete MedWatch safety summary, including a link to the FDA Drug Safety Communication, at:
[http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm215249.htm]

Posted 06/09/2010

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Defibtech DBP-2800 Battery Packs used in Lifeline AED and ReviveR AED: Recall

Audience: Emergency Medicine
[Posted 06/09/2010]
ISSUE: Defibtech, LLC, notified customers of a recall of 5,418 DBP-2800 Battery Packs used in the Lifeline AED and ReviveR AED (semi-automatic external defibrillators). When the AED is used with an affected battery pack, the AED may falsely detect an error condition during charging for a shock, then cancel charge and not provide therapy.
BACKGROUND: This recall affects all DBP-2800 Battery Packs shipped prior to June 4, 2007. The DBP-2800 battery packs affected by this recall have been distributed globally to fire departments, EMS, health clubs, schools, and other organizations.
RECOMMENDATION: The company has identified recommendations for the end customer to follow until the battery pack has been corrected, which allows the battery pack to remain in service. A copy of these recommendations is being mailed to all affected customers, and is available on the web at http://www.defibtech.com/batteryFA.
Read the complete MedWatch Safety Summary including a link to the firm press release at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm214916.htm

Posted 06/09/2010
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FDA MedWatch – June 2010 FDA Patient Safety News now available

FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals. It covers significant safety alerts, recalls, new product approvals, and offers important tips on protecting patients. Read the complete stories and watch or download the video program at www.fda.gov/psn. You may have already received notification of some of these safety issues through the MedWatch E-list. However, many of these PSN stories contain video footage and demonstrations that may be especially useful to clinicians and educators in healthcare facilities and academic institutions.
Stories in the June 2010 edition include:
New Formulation for OxyContin
Reformulation makes it more difficult to misuse or abuse the drug…
First Absorbable Sealant Patch for Cardiovascular Surgery
TachoSil provides surgeons with an additional tool to help control bleeding…
Reduced Effect from Plavix in Some Patients
Tests are available to identify “poor metabolizers” of the drug based on genetic makeup…
Muscle Injury from High Doses of Zocor
Ongoing safety review indicates increased risk of muscle injury with 80 mg. dose of simvastatin…
Companies to Stop Marketing Unapproved Nitroglycerin Tablets
Hospitals and pharmacies that buy unapproved nitroglycerin tablets from Glenmark Generics and Konec Inc. will need to switch to approved ones…
Boxed Warning for Exjade
Warning highlights the need for close monitoring of a patient’s renal and hepatic function…
Hemolysis Risk with WinRho SDF
Closely monitor patients for signs and symptoms of hemolysis…
Avoiding Problems with Temporary Cardiac Pacing
An FDA article from Nursing2010 on ways to avoid misconnections, disconnections, and lead fractures…
Caution about Sexual Enhancement Supplements
“All natural” supplements may contain ingredients that could pose a serious health risk…
Phase-Out of CFC Inhalers
Patients using Aerobid, Combivent or Maxair should talk to their doctors about switching to another product…

You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact support@govdelivery.com.
This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
Posted 06/07/2010

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FDA MedWatch – Intravenous Medications Manufactured by Claris: Recall due to contamination of products

*Metronidazole, Ciprofloxacin and Ondansetron sold under the Claris, Sagent Pharmaceuticals, Pfizer, and West-Ward Pharmaceuticals labels.*
*Audience: Pharmacists, Hospital Risk Managers*
FDA notified healthcare professionals not to use the intravenous medications, metronidazole, ciprofloxacin and ondansetron manufactured by Claris Lifesciences due to contamination. These products were all manufactured on the same manufacturing line and sold under the Claris, Sagent Pharmaceuticals, Pfizer, and West-Ward Pharmaceuticals labels. The FDA received reports of floating matter in intravenous bags of metronidazole and ondansetron. Foreign matter should not be present in a sterile injectable product. Healthcare professionals should not use these products and should immediately remove them from their pharmacy inventories. Claris is initiating a recall of all lots of these products. FDA is further investigating the situation and will notify the public when new information becomes available. Please review the linked Public Health Alert for a list of the affected and recalled products.
Read the complete MedWatch 2010 Safety summary, including a link to the Public Health alert, at
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm214034.htm

Posted 06/01/2010

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FDA MedWatch – Orlistat (marketed as Alli and Xenical): Labeling Change

Orlistat (marketed as Alli and Xenical): Labeling Change
Audience: Family Practice healthcare professionals, patients/consumers
FDA notified healthcare professionals and patients that it has approved a revised label for Xenical to include new safety information about cases of severe liver injury that have been reported rarely with the use of this medication. The agency is also adding a new warning about rare reports of severe liver injury to the OTC Drug Facts label for Alli.
Xenical and Alli are medications used for weight-loss that contain different strengths of the same active ingredient, orlistat. Xenical (orlistat 120 mg) is available by prescription and Alli (orlistat 60 mg) is sold over-the-counter without a prescription. This new safety information, originally announced in August 2009, is based on FDA’s completed review of orlistat.
Healthcare professionals should weigh the benefits of weight-loss with the potential risks associated with Xenical and Alli before prescribing or recommending these medications to their patients; patients should stop use of orlistat and contact their healthcare professional if they develop the signs and symptoms of liver injury, including itching, yellow eyes or skin, dark urine, light-colored stools, or loss of appetite.
Read the complete MedWatch safety summary, including links to the FDA Drug Safety Communication and Questions and Answers pages, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm213448.htm

Posted 05/26/2010

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FDA MedWatch – Proton Pump Inhibitors (PPI): Class Labeling Change

Proton Pump Inhibitors (PPI): Class Labeling Change
including Nexium, Dexilant, Prilosec, Zegerid, Prevacid, Protonix, Aciphex, Vimovo, Prilosec OTC, Zegerid OTC, and Prevacid 24HR
Audience: Family Practice, consumers
[Posted 05/25/2010] FDA notified healthcare professionals and patients of revisions to the prescription and over-the-counter [OTC] labels for proton pump inhibitors, which work by reducing the amount of acid in the stomach, to include new safety information about a possible increased risk of fractures of the hip, wrist, and spine with the use of these medications.
The new safety information is based on FDA’s review of several epidemiological studies that found those at greatest risk for these fractures received high doses of proton pump inhibitors or used them for one year or more. The majority of the studies evaluated individuals 50 years of age or older and the increased risk of fracture primarily was observed in this age group. While the greatest increased risk for fractures in these studies involved people who had been taking prescription proton pump inhibitors for at least one year or who had been taking high doses of the prescription medications (not available over-the-counter), as a precaution, the “Drug Facts” label on the OTC proton pump inhibitors (indicated for 14 days of continuous use) also is being revised to include information about this risk. FDA recommends healthcare professionals, when prescribing proton pump inhibitors, should consider whether a lower dose or shorter duration of therapy would adequately treat the patient’s condition.
The safety communication includes a data summary with a table and references which support the epidemiological studies reviewed for this communication.
Read the complete MedWatch safety summary, including links to the FDA Drug Safety Communication and Consumer Health Update pages, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm213321.htm

Posted 05/26/2010

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Metronidazole injection 500 mg / 100 ml: Voluntary recall due to non-sterility

Audience: Infectious Disease, Pharmacy
Sagent Pharmaceuticals, Inc. announced the voluntary nationwide recall of all lots of metronidazole injection, USP 500mg / 100mL manufactured by Claris Lifesciences and distributed by Sagent due to the discovery of non-sterility in two lots of metronidazole injection. Non-sterility of an antimicrobial administered via the intravenous route has the potential to result in infections, which could be fatal, especially in patients who are immunocompromised. Sagent is not aware of any adverse patient events resulting from this product and is continuing its diligent investigation of the situation.
The lot numbers being recalled are: A090742, A090743, A090744, A090745, A090746, A090769, A090770, A090771, A090772, A090773, A090774, A090775, A090776, A090968, A091014, A000013, A000016 and A000019, which were distributed to hospitals, wholesalers and distributors nationwide from February through May 2010. Metronidazole injection, USP is an intravenous antimicrobial product used to treat infections and is supplied in a single dose plastic container.
Read the complete MedWatch 2010 Safety alert including a link to the firm press release at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm212311.htm
Posted 05/17/2010

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FDA MedWatch – Rotarix Vaccine: Update to Clinicians and Public Health Professionals

Audience: Pediatric and family practice healthcare professionals, public health professionals
[UPDATED 05/16/2010] FDA has determined it is appropriate for clinicians and health care professionals to resume the use of Rotarix and to continue the use of RotaTeq. Based on a careful evaluation of laboratory results from the manufacturers and its own laboratories, a thorough review of the scientific literature, and input from scientific and public health experts, the agency is revising its recommendation to temporarily suspend use of the Rotarix vaccine. FDA has also determined that RotaTeq vaccine should remain in use.
In its decision, FDA considered that both vaccines have strong safety records, including clinical trials involving tens of thousands of patients as well as clinical experience with millions of recipients. FDA has no evidence that either porcine circovirus (PCV1 or PCV2) poses a safety risk in humans, and notes that neither is known to cause infection or illness in humans. The benefits of the vaccines are substantial, and include prevention of hospitalization for severe rotavirus disease in the United States and of death in other parts of the world. he benefits outweigh the risk, which is theoretical. FDA and the manufacturers will continue to investigate the findings of PCV in rotavirus vaccines and will evaluate information from ongoing testing by FDA and the manufacturers.
Read the complete MedWatch 2010 Safety summary, including the original March 22 notice and links to the updates for Healthcare Professionals and for Parents/Caregivers, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm205640.htm

Posted 05/17/2010

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FDA MedWatch – The MedWatch March 2010 Drug Safety Labeling Changes posting includes 44 products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.

The “Summary Page” provides a listing of drug names and safety labeling sections revised:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm209165.htm

Clicking on a drug product name in the Summary View will take you to the “detailed view” page, which identifies safety labeling sections and subsections revised, along with a brief summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections.
The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and WARNINGS sections:

Propylthiouracil tablets
Aptivus (tipranavir)
Crixivan (indinavir sulfate)
Invirase (saquinavir mesylate)
Kaletra (lopinavir/ritonavir)
Lexiva (fosamprenavir calcium)
Prezista (darunavir)
Reyataz (atazanavir)
Viracept (nelfinavir mesylate)
Acephen (acetaminophen)
FeverAll (acetaminophen)
Ortho Evra (norelgestromin/ethinyl estradiol)
Rapamune (sirolimus)
Sandimmune (cyclosporine)
Tarceva (erlotinib)
Tisseel (Fibrin Sealant)
Uroxatral (alfuzosin HCl)
Valtrex (valacyclovir hydrochloride)
Ventavis (iloprost)
Vytorin (ezetimibe/simvastatin)
Yasmin (drospirenone 3 mg/ethinyl estradiol 0.03 mg)
Yaz (drospirenone 3 mg/ethinyl estradiol 0.02 mg)
Zocor (simvastatin)
Zonegran (zonisamide)
Zyprexa Relprevv (olanzapine)

Posted 05/17/2010

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FDA MedWatch – May 2010 FDA Patient Safety News now available

Counterfeit Surgical Mesh
Examine polypropylene mesh products from all manufacturers for anything unusual that might indicate the product could be counterfeit…

Recall of Arrow IV Tubing Sets, Accessories
Recall of approximately 2,000 types of Arrow products, including IV tubing sets and accessories, because they may not be sterile…

SureStep Test Strips Recalled
Certain lots of SureStep glucose test strips may provide falsely low results when glucose levels are above 400 mg/dL…

Recall of UniCel DxC Clinical Analyzers
The importance of following twice-a-week maintenance procedures…

Review of Invirase and Cardiac Arrhythmias
FDA is reviewing clinical trial data suggesting an increased risk of cardiac arrhythmias…

Reducing the Risk of Overfill with HomeChoice Peritoneal Dialysis
Children and critically ill patients may be at higher risk…

Risk Management Program for Procrit, Epogen and Aranesp
Studies have shown that ESAs can increase the risk of tumor growth and shorten survival in cancer patients…

Avoiding Maalox Mix-ups
Using the wrong liquid Maalox product could be harmful…

Posted 05/06/2010

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FDA MedWatch – Baxter Colleague Infusion Pumps: FDA Ordering Recall

Audience: Hospital Risk Managers
FDA notified healthcare professionals and consumers that it has ordered Baxter to recall and destroy all of its Colleague Volumetric Infusion Pumps (Colleague pumps) currently in use. This action is based on a longstanding failure to correct many serious problems with the pumps. The FDA believes there may be as many as 200,000 of those pumps currently in use. FDA is ordering Baxter to recall and destroy all Colleague infusion pumps, reimburse customers for the value of the recalled device, and assist in finding a replacement for these customers. Hospitals and other users of Baxter’s Colleague pumps will be receiving further instruction and information from Baxter and the FDA regarding their transition.
Read the complete MedWatch 2010 Safety alert including links to the FDA News release and previous MedWatch alert, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm210695.htm
Posted 05/04/2010

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FDA MedWatch – Cardiac Science Automated External Defibrillators – Powerheart, Cardiovive, NK, Responder models: Class I Recall

Audience: Emergency Medical Personnel, Risk Managers
[UPDATED 04/27/2010] This update alerts users that Nihon Kohden (NK) and GE Responder models are also affected although they were not identified in earlier communications about this recall. In addition, Cardiac Science issued a software upgrade for the devices’ self tests on 02/24/10 for the Powerheart automatic external defibrillators (Models 9390A and 9390E) and is planning on issuing a similar software upgrade for other affected devices. However, FDA’s review of the updated software indicates that it detects some but not all electrical component defects. Updated recommendations and complete list of affected models can be found in the 04/27/2010 Medical Device Update.
Read the complete MedWatch 2010 Safety alert including links to the original Class 1 recall notice and updated recommendations and other information, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm205165.htm
Posted 04/28/2010

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FDA MedWatch – LIFEPAK 15 Monitor/Defibrillator by Physio-Control Inc.

Audience: Emergency medical personnel, consumers
FDA notified healthcare professionals of a Class I recall of LIFEPAK 15 Monitor/Defibrillator manufactured and distributed between Marcy 26, 2009 and December 15, 2009. There is a potential for the device to unexpectedly:

Power Off then On by itself.
Power Off then NOT turn On.
Power Off by itself requiring the operator to turn it back On.
Stay powered On and not allow itself to be turned Off.

Healthcare professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Online: www.fda.gov/MedWatch/report.htm1
Phone: 1-800-332-1088
Mail: return the postage-paid FDA form 3500, which may be downloaded from the MedWatch “Download Forms2” page, to address on the pre-addressed form
Fax: 1-800-FDA-0178

Read the complete MedWatch 2010 Safety summary, including a link to the Recall Notice, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm209467.htm
Posted 04/26/2010

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FDA MedWatch – March 2010 Drug Safety Labeling Changes: 40 drugs with changes to Boxed Warning, Warnings, Contraindications, Precautions, Adverse Reactions

The MedWatch March 2010 Drug Safety Labeling Changes posting includes 40 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.
The “Summary Page” provides a listing of drug names and safety labeling sections revised:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm207384.htm

Clicking on a drug product name in the Summary View will take you to the “detailed view” page, which identifies safety labeling sections and subsections revised, along with a brief summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections.
The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and WARNINGS sections:

Plavix (clopidogrel bisulfate)
Caduet (amlodipine besylate/atorvastatin calcium)
Lotrel (amlodipine besylate/benazapril hydrochloride)
Meridia (sibutramine hydrochloride)
Skelid (tiludronate disodium)
Avelox (moxifloxacin)
ChloraPrep [chlorhexidine gluconate (2% w/v) and isopropyl alcohol (70% v/v)]
DuraPrep Surgical (iodine povacrylex (0.7% available iodine) and isopropyl alcohol (74% w/w)
Emend (fosaprepitant dimeglumine)
Femara (letrozole)
Fosamax Plus D (alendronate sodium/cholecalciferol)
Hycamtin (topotecan hydrochloride)
Rapaflo (silodosin)
Sustiva (efavirenz)
Toprol XL (metoprolol succinate)
Vivitrol (naltrexone for extended-release)
Vytorin (ezetimibe/simvastatin)
Zocor (simvastatin)

Posted 04/16/2010

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FDA MedWatch – April 2010 FDA Patient Safety News now available

FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals. It covers significant safety alerts, recalls, new product approvals, and offers important tips on protecting patients. Read the complete stories and watch or download the video program at www.fda.gov/psn. You may have already received notification of some of these safety issues through the MedWatch E-list. However, many of these PSN stories contain video footage and demonstrations that may be especially useful to clinicians and educators in healthcare facilities and academic institutions.
Stories in the April 2010 edition include:
Caution on Zyprexa for Adolescents
Adolescents may be at greater risk for weight gain and hyperlipidemia than adults when treated with Zyprexa…
Certain Powerheart/CardioVive/CardioLife AED Recalled
Recalled devices may fail to deliver therapy during a resuscitation attempt…
Recall of Q-Syte Luer Access Devices
Affected devices may cause an air embolism or blood or therapy fluids to leak…
Cardiovascular Risk with Meridia
Meridia (sibutramine), used to treat obesity, is now contraindicated in patients with a history of cardiovascular disease…
SafeSheath CSG Hemostatic Introducer Recalled
The soft radiopaque tip may fracture while the lead is being implanted and leave fragments in a patient’s vasculature…
Measuring Rapamune Blood Concentrations
Different methods for assaying Rapamune (sirolimus) blood concentrations are not interchangeable and can give different results; may lead to improper dose adjustments…
Plastic Rotors for Hettich Centrifuges Recalled
Rotors on affected models may crack apart and destroy centrifuge housing, creating a safety hazard…
Serious Liver Disorder with Videx
Cases of a rare but serious complication, non-cirrhotic portal hypertension, have been reported in patients taking Videx (didanosine) or Videx EC, to treat HIV infection…
GlucoPro Insulin Syringes Recall
Needles with expiration dates before November 2011 may detach from the syringe…
Potentially Fatal Salmonella Infections from Pet Turtles
Turtles may look like cute pets but they are responsible for an estimated 70,000 cases of Salmonella infections each year… Posted 04/09/2010

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FDA MedWatch – Zocor (simvastatin): increased risk of muscle injury with high doses

Simvastatin is sold as a single-ingredient generic medication and as the brand-name, Zocor. It is also sold in combination with ezetimibe as Vytorin; and niacin as Simcor
Audience: Primary care providers, patients
FDA notified healthcare professionals and patients that, based on review of data from a large clinical trial and other sources, there is an increased risk of muscle injury in patients taking the highest approved dose of the cholesterol-lowering medication, Zocor (simvastatin) 80 mg, compared to patients taking lower doses of simvastatin and possibly other drugs in the “statin” class. FDA is also reviewing data from other clinical trials, observational studies, adverse event reports, and data on prescription use of simvastatin to better understand the relationship between high-dose simvastatin use and muscle injury.
Recommendations for healthcare professionals, recommendations for patients and a data summary of information used in this ongoing review are provided in the Drug Safety Communication.
Read the complete MedWatch 2010 Safety summary, including a link to the Safety Communication and current Prescribing Information, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm205404.htm

Posted 03/19/2010

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FDA MedWatch – Plavix (clopidogrel): Boxed warning added regarding reduced effectiveness of Plavix in poor metabolizers

Plavix (clopidogrel): Reduced effectiveness in patients who are poor metabolizers of the drug
Audience: Cardiology healthcare professionals, patients
FDA notified healthcare professionals and patients that a Boxed Warning has been added to the prescribing information for Plavix, an anti-blood clotting medication. The Boxed Warning in the drug label will include information to:

Warn about reduced effectiveness in patients who are poor metabolizers of Plavix. Poor metabolizers do not effectively convert Plavix to its active form in the body.
Inform healthcare professionals that tests are available to identify genetic differences in CYP2C19 function.
Advise healthcare professionals to consider use of other anti-platelet medications or alternative dosing strategies for Plavix in patients identified as poor metabolizers.

Plavix is given to reduce the risk of heart attack, unstable angina, stroke, and cardiovascular death in patients with cardiovascular disease. Plavix works by decreasing the activity of blood cells called platelets, making platelets less likely to form blood clots. A data summary and additional information for healthcare professionals and patients are provided in the linked Drug Safety Communication.
Read the complete MedWatch 2010 Safety summary, including a link to the Drug Safety Communication at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm204256.htm
Posted 03/12/2010

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FDA MedWatch – Oral Bisphosphonates:Ongoing Safety Review of Atypical Subtrochanteric Femur Fractures-have not shown clear connection between bisphosphonates, risk of fracture

Oral Bisphosphonates: Ongoing Safety Review of Atypical Subtrochanteric Femur Fractures

Audience: Orthopedic healthcare professionals, patients
FDA notified healthcare professionals and patients that at this point, the data that FDA has reviewed have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures. FDA is working with outside experts, including members of the recently convened American Society of Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force, to gather more information and evaluate the issue further.
FDA recommends that healthcare professionals follow the recommendations in the drug label when prescribing oral bisphosphonates.
Patients should continue taking oral bisphosphonates unless told by their healthcare professional to stop. Patients should talk to their healthcare professional if they develop new hip or thigh pain or have any concerns with their medications.

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm204127.htm
Posted 03/12/2010

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FDA MedWatch – February 2010 Drug Safety Labeling Changes: 24 drugs with changes to Boxed Warning, Warnings, Contraindications, Precautions, Adverse Reactions

The MedWatch February 2010 Drug Safety Labeling Changes posting includes 24 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.

The “Summary Page” provides a listing of drug names and safety labeling sections revised:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm202912.htm

Clicking on a drug product name in the Summary View will take you to the “detailed view” page, which identifies safety labeling sections and subsections revised, along with a brief summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections.

The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and WARNINGS sections:

Caduet (amlodipine besylate/atorvastatin calcium)
Cialis (tadalafil)
Accutane (isotretinoin)
Bystolic (nebivolol)
Carbocaine (mepivacaine HCl)
Didrex (benzphetamine hydrochloride)
Excedrin Migraine (250 mg acetaminophen/ 250 mg aspirin/ 65 mg caffeine)
Genotropin (somatropin [rDNA origin]
Lanoxin (digoxin)
Marcaine (bupivacaine HCl)
Marcaine with Epinephrine 1:200,000 (as bitartrate)(bupivacaine HCl and epinephrine)
Marcaine Spinal (bupivacaine HCl)
Naropin (ropivacaine HCl)
Nesacaine (chloroprocaine HCl)
Nesacaine-MPF (chloroprocaine HCl)
Norvasc (amlodipine besylate)
Prepidil (dinoprostone)
Rocephin (ceftriaxone sodium)
Savella (milnacipran HCl)
Treanda (bendamustine hydrochloride)
Xylocaine (lidocaine HCl)
Xylocaine (lidocaine HCl and epinephrine)

Posted 03/12/2010

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FDA MedWatch – March 2010 FDA Patient Safety News now available

FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals. It covers significant safety alerts, recalls, new product approvals, and offers important tips on protecting patients. Read the complete stories and watch or download the video program at www.fda.gov/psn. You may have already received notification of some of these safety issues through the MedWatch E-list. However, many of these PSN stories contain video footage and demonstrations that may be especially useful to clinicians and educators in healthcare facilities and academic institutions.
Stories in the March 2010 edition include:
Recall and Safety Precautions for Huber Needles
Precautions when using Huber needles to access implanted ports…
Don’t Use Thermoflect Products with MRI
Maker of Thermoflect blankets, apparel, etc. advises against using these antihypothermia products with MRI…
Valproate Sodium and Birth Defects
Used to treat epilepsy, valproate products (such as Depacon, Depakene, Stavzor, and Depakote) have been associated with neural tube defects, craniofacial defects, and other malformations…
Kidney Impairment with Byetta
Byetta (exenatide) should not be used in patients with severe renal impairment or end-stage renal disease…
Cleviprex Recalled due to Particulates
Certain lots of the injectable antihypertensive Cleviprex recalled…
Warning on Counterfeit Alli
The counterfeit Alli contains the stimulant drug sibutramine; ways to identify possible counterfeits…
Medical Errors from Misreading Letters and Numbers
ISMP points out that mistakes are easy to make because some of the alphanumeric symbols look so similar…
Cautions about Sexual Enhancement Products
“All natural” supplements may contain ingredients that could pose a serious health risk…

Posted 03/04/2010

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FDA MedWatch: Baxter HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems: Class I Recall

Audience: Nephrology healthcare professionals, patients
FDA and Baxter notified healthcare professionals of a Class I recall of the HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems, which are prescription medical devices used to treat pediatric and adult patients with kidney failure. Reports of serious injuries and at least one death have been associated with increased Intraperitoneal Volume (IIPV), also known as overfill of the abdominal cavity. IIPV may result in serious injury or death from conditions including but not limited to: abdominal wall and/or diaphragmatic hernias, hydrothorax, heart failure, acute hypertension, pulmonary edema, decreased pulmonary function, pericardial effusion, and peritonitis.
Children and non-verbal patients may be at increased risk because of their smaller size or inability to communicate. Increased monitoring of these patients is recommended. Other vulnerable populations include critically ill patients and patients with pulmonary and hemodynamic instability.
Patients and caregivers should watch for the potential signs of IIPV. If patients or caregivers notice any of the signs of IIPV, stop the device, initiate manual drain, and contact your doctor immediately. Clinicians should weigh the risks and benefits to continued use of these devices by their patients versus other forms of dialysis therapy. Clinicians should also review the prescription settings for patients who continue to use these devices. See the Recall Notice for a listing of affected models/product code numbers.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm202885.htm

Posted 03/03/2010

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FDA MedWatch: OneTouch SureStep Test Strips (LifeScan): Recall

Audience: Diabetes healthcare professionals, consumers
LifeScan and FDA notified healthcare professionals of a voluntary recall of eight lots of OneTouch SureStep Test Strips, used by people with diabetes to measure their blood glucose levels at home. The test strips are being recalled because they may provide falsely low glucose results when the glucose level is higher than 400 mg/dL.
If patients use the falsely low test results to determine their insulin dose, they may give themselves too little insulin, which could result in poor blood glucose control. High blood glucose must be recognized and treated promptly to avoid serious complications, such as coma and death.
The eight lots of consumer OneTouch SureStep Test Strips being recalled are identified in the firm’s press release. Lot numbers are located on the outer carton and test strip vial. LifeScan estimates approximately fourteen thousand packages (50- and 100-count) of consumer OneTouch SureStep Test Strips were distributed nationwide between August 1, 2009 and January 28, 2010.
It is important that patients with recalled test strips continue to test their blood glucose. Patients with access to a meter that does not use OneTouch SureStep Test Strips should use this other meter to test their blood glucose until replacement product from LifeScan arrives. If an alternate meter is not available, patients may continue to test using the recalled OneTouch SureStep Test Strips. However, if patients obtain results above 400 mg/dL, they should contact their healthcare professional for further instructions because their glucose may be significantly higher.
Read the complete MedWatch 2010 Safety summary, including a link to the firm’s press release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm202254.htm

Posted 03/01/2010

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Invirase (saquinavir): Ongoing safety review of clinical trial data-Possible association with abnormal heart rhythms when used in combination with Norvir (ritonavir)

Audience: HIV/AIDS and cardiological healthcare professionals, patients
FDA notified healthcare professionals and patients that it is reviewing clinical trial data about a potentially serious effect on the heart from the use of Invirase (saquinavir) in combination with Norvir (ritonavir), antiviral medications given together to treat HIV infection.
The data suggest that together the two drugs may affect the electrical activity of the heart, known as prolonged QT or PR intervals. A prolonged QT interval can increase the risk for a serious abnormal rhythm called torsades de pointes. A prolonged PR interval can cause the electrical signal responsible for generating a heart beat to slow or even stop, known as heart block.
FDA’s analysis of these data is ongoing. The agency will update the public as soon as this review is complete. However, healthcare professionals should be aware of this potential risk for changes to the electrical activity of the heart. Invirase and Norvir should not be used in patients already taking medications known to cause QT interval prolongation such as Class IA (such as quinidine,) or Class III (such as amiodarone) antiarrhythmic drugs, or in patients with a history of QT interval prolongation.
Patients should not stop taking their prescribed antiviral medications. Patients who are concerned about possible risks associated with using Invirase and Norvir should talk to their healthcare professional.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Online: www.fda.gov/MedWatch/report.htm
Phone: 1-800-332-1088
Mail: return the postage-paid FDA form 3500, which may be downloaded from the MedWatch “Download Forms” page, to address on the pre-addressed form
Fax: 1-800-FDA-0178

Read the complete MedWatch 2010 Safety summary, including a link to the Drug Safety communication and News Release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm201563.htm

Posted 02/23/2010

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FDA MedWatch – Avandia (rosiglitazone): FDA reviewing a large, long-term clinical study on possible risks for cardiovascular outcomes with use of rosiglitazone

Audience: Endocrinology, cardiology healthcare professionals, patients
FDA notified healthcare professional and patients that it is reviewing the primary data from a large, long-term clinical study, RECORD, on possible cardiovascular risks with the diabetes drug, Avandia (rosiglitazone). In addition to the clinical trial, a number of observational studies of the cardiovascular safety of rosiglitazone have been published and FDA has been reviewing these on an ongoing basis.
These reviews are ongoing and no new conclusions or recommendations about the use of rosiglitazone in the treatment of type 2 diabetes have been made at this time. Once FDA completes its review of the data from the RECORD study, the agency will present the totality of new and existing cardiovascular safety data on rosiglitazone at a public meeting in July 2010. The Agency will provide an updated assessment of the risks and benefits of rosiglitazone in the treatment of type 2 diabetes.
FDA recommends that healthcare professionals follow the recommendations in the drug label when prescribing rosiglitazone. This includes a Boxed Warning. Patients should continue taking rosiglitazone unless told by their healthcare professional to stop. Patients who are concerned about the possible risks associated with using rosiglitazone should talk to their healthcare professional.
Read the complete MedWatch 2010 Safety summary, including a link to the Drug Safety communcation, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm201446.htm

Posted 02/23/2010

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FDA MedWatch – Maalox Total Relief: Medication Use Errors- Consumers with history of GIulcers or bleeding disorder should not use product because it contains substance related to aspirin

Audience: Consumers, Healthcare professionals
FDA notified consumers and healthcare professionals about reports of serious medication errors involving consumers who used Maalox Total Relief when they had intended to use a Maalox liquid antacid product. Maalox Total Relief and the traditional Maalox products are both liquid medications available without a prescription, but are not interchangeable and are intended to treat different medical conditions. Maalox Total Relief is an upset stomach reliever and anti-diarrheal medication, while traditional Maalox liquid products Maalox Advanced Regular Strength and Maalox Advanced Maximum Strength are antacids.
Maalox Total Relief is not appropriate for individuals who want to use an antacid, since it contains the active ingredient bismuth subsalicylate which is chemically related to aspirin and may cause serious adverse effects such as bleeding. Maalox Total Relief should not be used in people who have or have a history of gastrointestinal ulcers or a bleeding disorder. It also should not be taken by children and teens if they are recovering from a viral infection, nor by individuals who are taking certain medications including: oral antidiabetic drugs (OADs), anticoagulation (thinning the blood) drugs such as warfarin (Coumadin) and clopidogrel (Plavix), non-steroidal anti-inflammatory drugs (NSAIDS), and other anti-inflammatory drugs.
The Drug Safety Communication contains additional information for consumers and healthcare professionals, as well as product label photos.
Read the complete MedWatch 2010 Safety summary, including links to the Drug Safety Communication and FDA news release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm200672.htm
Posted 02/22/2010

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FDA MedWatch – January 2010 Drug Safety Labeling Changes: 36 drugs with changes to Boxed Warning, Warnings, Contraindications, Precautions, Adverse Reactions

The MedWatch January 2010 Drug Safety Labeling Changes posting includes 36 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.
The “Summary Page” provides a listing of drug names and safety labeling sections revised:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm200254.htm

Clicking on a drug product name in the Summary View will take you to the “detailed view” page, which identifies safety labeling sections and subsections revised, along with a brief summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections.
The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and WARNINGS sections:

Exjade (deferasirox)
Aristocort Forte (triamcinolone diacetate)
Boniva (ibandronate sodium)
Effexor (venlafaxine HCl)
Invirase (saquinavir mesylate)
Kaletra (lopinavir/ritonavir)
RotaTeq (rotavirus vaccine, live, pentavalent)
Tykerb (lapatinib)
Cancidas (caspofungin acetate)
Cardene (nicardipine hydrochloride)
Coumadin (warfarin sodium)
Crestor (rosuvastatin calcium)
Kenalog (triamcinolone acetonide)
Pexeva (paroxetine mesylate)
R-Gene 10 (arginine hydrochloride)
Remodulin (treprostinil)
Symbyax (olanzapine and fluoxetine hydrochloride)
Toprol-XL (metoprolol succinate)
Videx EC (didanosine)
Viramune (nevirapine)
Zyprexa (olanzapine)
Posted 02/19/2010

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FDA MedWatch – Exjade (deferasirox): Boxed Warning – Changes to Prescribing Information re: risk of renal impairment/failure, hepatic impairment/failure or gastrointestinal hemorrhage

Audience: Hematology-Oncology healthcare professionals
Novartis Oncology and FDA notified healthcare professionals about recent changes in the Prescribing Information (PI) for Exjade, indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. New language was added to the Contraindications, Warnings and Precautions, and Drug Interactions sections of the PI, including a Boxed Warning, that the product may cause:

renal impairment, including failure
hepatic impairment, including failure
gastrointestinal hemorrhage

In some reported cases, these reactions were fatal. These reactions were more frequently observed in patients with advanced age, high risk myelodysplastic syndromes, underlying renal or hepatic impairment or low platelet counts. Exjade therapy requires close patient monitoring, including measurement of serum creatinine and/or creatinine clearance as specified in the PI and serum transaminases and bilirubin as specified in the PI.
Read the complete MedWatch 2010 Safety summary, including a link to the Dear Healthcare Professional letter and revised Prescribing Information, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm200850.htm

Posted 02/19/2010

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FDA MedWatch – Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp: Drug Safety Communication

Audience: Oncological and nephrological healthcare professionals and patients
FDA and Amgen notified healthcare professionals and patients that all ESAs must be used under a REMS risk management program. As part of the risk management program, a Medication Guide explaining the risks and benefits of ESAs must be provided to all patients receiving an ESA. Under the ESA APPRISE Oncology program, Amgen will ensure that only those hospitals and healthcare professionals who have enrolled and completed training in the program will prescribe and dispense ESAs to patients with cancer. Amgen is also required to oversee and monitor the program to ensure that hospitals and healthcare professionals are fully compliant with all aspects of the program. FDA is requiring a REMS because studies show that ESAs can increase the risk of tumor growth and shorten survival in patients with cancer who use these products. Studies also show that ESAs can increase the risk of heart attack, heart failure, stroke or blood clots in patients who use these drugs for other conditions.
Read the complete MedWatch 2010 Safety summary including links to the Drug Safety Communication and current Prescribing Information for these products, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm200391.htm

Posted 02/17/2010

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FDA MedWatch – Videx/Videx EC (didanosine): Labeling Revision – Risk of Non-Cirrhotic Portal Hypertension

Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife models): Recall
Audience: Emergency medical professionals, hospital risk managers
Cardiac Science Corporation and FDA notified healthcare professionals and consumers of a recall because the automated external defibrillator (AED) may not be able to deliver therapy during a cardiac resuscitation attempt, which may lead to serious adverse events or death. These AEDs were manufactured in a way that makes them potentially susceptible to failure under certain conditions. Each of the approximately 12,200 devices affected in this recall can be confirmed at the Cardiac Science Web site, www.cardiacscience.com/AED195. The affected AEDs were manufactured or serviced between October 19, 2009 and January 15, 2010 and include the following models – Powerheart 9300A, 9300E, 9300P, 9390A, 9390E, CardioVive 92532 and CardioLife 9200G and 9231. Each affected AED should immediately be removed from service since it may not deliver the expected therapy.
Read the complete MedWatch 2010 Safety summary, including a link to the firm press release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm200138.htm

Posted 02/10/2010

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FDA MedWatch – February 2010 FDA Patient Safety News now available

FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals. It covers significant safety alerts, recalls, new product approvals, and offers important tips on protecting patients. Read the complete stories and watch or download the video program at www.fda.gov/psn. You may have already received notification of some of these safety issues through the MedWatch E-list. However, many of these PSN stories contain video footage and demonstrations that may be especially useful to clinicians and educators in healthcare facilities and academic institutions.
Stories in the February 2010 edition include:
Caution on Powerheart and CardioVive Automated External Defibrillators
Affected devices may malfunction unexpectedly and self-test feature may not show a problem…
Cardiovascular Problems with Lexiva
Patients should have their cholesterol and triglycerides tested before starting therapy with Lexiva and at periodic intervals during treatment
FDA Recommendations on STERIS SYSTEM 1 Processor
Facilities should take steps to transition to legally marketed alternatives to the SS1; recommended time period for transition extended to 18 months…
Chondrolysis with Continuously Infused Local Anesthetics
Local anesthetics are not approved for intra-articular infusions, or for use in infusion devices like elastomeric pumps…
Synex II Spinal Implant Recalled
Because of the potential for these devices to collapse, patients who already have these implants should receive annual radiographic exams and pain assessment
New Warnings on Norpramin
Use extreme caution when giving this drug to patients with a family history of sudden death, cardiac dysrhythmias, and cardiac conduction disturbances…
Preventing Cross-Contamination in Endoscope Processing
Continuing reports of processing errors prompt joint communication from FDA, CDC and VA…
Mixups between Kapidex and Casodex
ISMP recommendations to help prevent these potentially serious mixups…
Posted 02/04/2010

*Manufacturer’s Notice* This is NOT an FDA notice.
Spire HD Cath Recalls and Field Corrections
Posted 02/02/2010

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FDA MedWatch – Videx/Videx EC (didanosine): Labeling Revision – Risk of Non-Cirrhotic Portal Hypertension

Audience – HIV/AIDS, Infectious Disease healthcare professionals
FDA notified healthcare professionals and patients about a rare, but serious, complication in the liver known as non-cirrhotic portal hypertension in patients using Videx or Videx EC (didanosine), a medication used to treat human immunodeficiency virus (HIV) infection. FDA became aware of cases of non-cirrhotic portal hypertension through adverse event reports submitted to FDA’s Adverse Event Reporting System. Based on the number of well-documented cases and exclusion of other causes of portal hypertension such as alcohol-related cirrhosis or hepatitis C, FDA concludes there is an association between use of didanosine and development of non-cirrhotic portal hypertension. Because of the potential severity of portal hypertension, including death from hemorrhaging esophageal varices, FDA has revised the Warning and Precautions section of the didanosine drug label to assure safe use of the medication. FDA believes the clinical benefits of didanosine for certain patients with HIV continue to outweigh its potential risks. The decision to use this drug, however, must be made on an individual basis between the treating physician and the patient.
Read the complete MedWatch 2010 Safety summary including a link to the Drug Safety Communication, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm199343.htm

Posted 01/30/2010

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FDA MedWatch – Edwards Lifesciences Aquarius Hemodialysis System: Recall – Clinically significant fluid imbalance and potential for users to repeatedly override the fluid imbalance alarm

Audience: Nephrology and hemodialysis healthcare professionals, hospital risk managers
FDA and Edwards Lifesciences notified healthcare professionals of a Class I recall of the Aquarius Hemodialysis System due to reports of clinically significant fluid imbalance and the potential for users to repeatedly override the fluid imbalance alarm. This could result in a decrease or increase in the volume of the circulating blood, which may result in serious injuries or death.
The recall includes model numbers: GEF08200, GEF09500, GEF09600, GEF09700, and GEF09800, using Software version 6.00.04. The product was distributed from July 12, 2007 through March 18, 2009. Baxter International, Inc. is the U.S. distributor of the Aquarius.
The company notified its customers of a planned software upgrade to prevent users from bypassing the fluid balance alarm more than five times in a 20-minute period.
Read the complete MedWatch 2010 Safety summary, including a link to the FDA recall notice, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm199203.htm
Posted 01/29/2010

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FDA Medwatch – Infusion Set Needles [Manufactured by Nipro for Exelint]: Recall

Exel/Exelint Huber needles,
Exel/Exelint Huber Infusion Sets
Exel/Exelint “Securetouch+” Safety Huber Infusion Sets
Audience: Hospital Risk Managers, Surgical Service personnel
FDA notified healthcare professionals of a Class I recall of Exel/Exelint Huber needles, Exel/Exelint Huber Infusion Sets and Exel/Exelint “Securetouch+” Safety Huber Infusion Sets, manufactured by Nipro Medical Corporation for Exelint International Corporation due to ‘coring’, the cutting or dislodging of silicone cores or slivers from the ports into which they are inserted. Huber needles are used to access ports implanted under the skin of chronically ill patients for repeated access to veins for the withdrawal of blood and infusion of medication, nutritional solutions, blood products, and imaging solutions.
Inspections conducted in October 2009 of Nipro facilities found that their needles “cored” in 60 to 72 percent of tests. The reason for this coring is related to design and manufacturing processes, which the FDA continues to investigate and will update the public if there are new developments.
Hospitals, clinics and patients who have needles from these lists should immediately stop using these affected products and return any unused products to Exelint International Corporation.
There are more than 2 million units impacted by this recall in distribution nationwide. Recalled needles were manufactured from January 2007 to August 2009. Units subject to recall have a lot number that begins with “07,” “08,” “09,” and one of the product codes or catalog numbers noted in the FDA news release.
Read the complete MedWatch 2010 Safety summary, including a link to the FDA News Release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm198728.htm
Posted 01/26/2010

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FDA MedWatch – Nipro GlucoPro Insulin Syringes: Recall

Audience: Pharmacists, diabetes healthcare professionals, consumers
Nipro Medical Corporation and FDA notified healthcare professionals of a voluntary nationwide recall of all GlucoPro Insulin Syringes. These syringes may have needles that detach from the syringe. If the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into the syringe, or remain in the skin after injection. This recall includes all product codes and lot numbers with expiration dates before 2011-11 (November 1, 2011). Product was distributed nationwide, including Puerto Rico. Consumers who have GlucoPro Insulin Syringes should stop using and return them to point of sale for reimbursement.
Read the complete MedWatch 2010 Safety summary, including a link to the firm press release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm198445.htm
Posted 01/25/2010

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FDA MedWatch – McNeil Consumer Healthcare Over-The-Counter Products: Recall

Audience: Consumers, Pharmacists
[Posted 01/15/2010] McNeil and FDA notified healthcare professionals of an expansion of the December 2009 recall. McNeil Consumer Healthcare has now applied broader criteria to identify and remove all product lots that it believes may have the potential to be affected, even if they have not been the subject of consumer complaints. Consumers who purchased product from the lots included in this recall should stop using the product and contact McNeil Consumer Healthcare for instructions on a refund or replacement. The affected product lot numbers for the recalled products can be found on the side of the bottle label. Any adverse reactions may also be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.
Read the complete MedWatch 2010 Safety summary, including a link to the firm press release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm197740.htm
Posted 01/15/2010

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FDA MedWatch – December 2009 Drug Safety Labeling Changes: 28 drugs with changes to Boxed Warning, Warnings, Contraindications, Precautions, Adverse Reactions

The MedWatch December 2009 Drug Safety Labeling Changes posting includes 28 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.

The “Summary Page” provides a listing of drug names and safety labeling sections revised:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm194965.htm

Clicking on a drug product name in the Summary View will take you to the “detailed view” page, which identifies safety labeling sections and subsections revised, along with a brief summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections.

The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and WARNINGS sections:

Arixtra (fondaparinux sodium)
Fragmin (dalteparin sodium)
Innohep (tinzaparin sodium)
Lovenox (enoxaparin sodium)
Actonel (risedronate sodium)
Amlodipine besylate/ Benazepril hydrochloride capsule
Didronel (etidronate disodium)
Innopran XL (propranolol hydrochloride)
Ortho Evra (norelgestromin and ethinyl estradiol)
Spiriva HandiHaler (tiotropium bromide)
Arranon (nelarabine)
Bicillin L-A (penicillin G benzathine) and Bicillin CR (penicillin G benzathine and penicillin G procaine)
Daytrana (methylphenidate)
Janumet (sitagliptin/metformin HCl)
Januvia (sitagliptin)
Lexiscan (regadenoson)
Seroquel (quetiapine fumarate)
Seroquel XR (quetiapine fumarate)
Topamax (topiramate)
Velcade (bortezomib)
Verelan PM (verapamil hydrochloride)
Posted 01/11/2010
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Rapamune (sirolimus): Drug Monitoring Recommendations

Audience: Transplantation and nephrology healthcare professionals, hospital laboratory directors
Wyeth notified healthcare professionals of changes to the Rapamune Prescribing Information regarding changes in the performance of an immunoassay used for therapeutic drug monitoring (TDM) of sirolimus. The TDM results reported from the assay are both assay and laboratory-dependent. In addition, the results may change over time. Therefore, adjustment to the targeted therapeutic range must be made with a detailed knowledge of the site-specific assay used.
Sirolimus whole blood concentrations can be measured by either chromatographic or immunoassay methodologies. These two methodologies are not directly interchangeable and the measured sirolimus whole blood concentrations depend on the type of assay used. As such, if different assays are used in monitoring a single patient, the dose of Rapamune might be adjusted improperly with potential consequences, such as allograft rejection if drug exposure is too low or toxic side effects if exposure is too high.
Wyeth has advised healthcare providers involved in the management of patients taking Rapamune to determine: 1) which assay is being used in their laboratory(ies); 2) if there is any change to the assay used; 3) if there is a change to the laboratory’s reference range and/or a subsequent change to the institution’s or referring center’s recommended range for sirolimus. With this information, target levels can be appropriately adjusted in order to achieve optimal clinical results.
It is critical that the clinician caring for a patient on sirolimus maintain communication with their laboratory to determine whether the assay used for measuring sirolimus concentrations has been changed.
Read the complete MedWatch 2010 Safety summary, including a link to the Wyeth Dear Healthcare Professional letter, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm197059.htm
Posted 01/11/2010

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FDA MedWatch – January 2010 FDA Patient Safety News now available

Complications with Negative Pressure Wound Therapy
FDA recommendations to help reduce the risk of serious complications with negative pressure wound therapy…

Warning Against Nebulizing Relenza Inhalation Powder
Relenza Inhalation Powder, which is used in the treatment and prophylaxis of influenza, is only intended to be inhaled using a Diskhaler…

Nationwide Recall of AccuSure Insulin Syringes
These syringe needles may detach from the syringe…

Recall of Certain Liquid Glucose Hexokinase Reagents
Laboratories should consider all test results obtained with the recalled reagents to be questionable…

Preventing Anaphylactic-type Reactions with Dexferrum
Updated boxed warning about giving patients a test dose and observing them for signs and symptoms of anaphylactic-type reactions every time Dexferrum is administered…

Energy Levels in External Biphasic Defibrillators
FDA is looking into reports in which a 200 joule biphasic defibrillator was ineffective in terminating an arrhythmia, whereas a subsequent shock from a 360 joule device resulted in immediate defibrillation or cardioversion…

Alert on Philips Avalon Fetal Monitors
While Philips continues to investigate, the company recommends several interim steps to reduce the likelihood of inaccurate readings or their impact…

Never Use Parenteral Syringes for Oral Medications
Once a parenteral syringe is filled with a liquid intended for oral use, it can be accidentally connected to an intravenous line, with potentially dangerous consequences…
Posted 01/07/2010

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Tylenol Arthritis Pain Caplet 100 count: Recall of all lots
Audience: Consumers, Pharmacists
McNeil Consumer Healthcare and FDA notified consumers that it is expanding a voluntary recall to include all available product lots of TYLENOL Arthritis Pain Caplet 100 count bottles, with the distinctive red EZ-OPEN CAP (Full list of lot numbers provided in press release at link below). In November 2009, 5 lots of this product were recalled due to consumer reports of an unusual moldy, musty, or mildew-like odor that was associated with nausea, stomach pain, vomiting and diarrhea. The odor is caused by the presence of a chemical 2,4,6-tribromoanisole, believed to be the breakdown of a chemical used to treat wooden pallets that transport and store packaging materials. The health effects of this compound have not been well studied, and to date all of the observed events reported to McNeil were temporary and non-serious. Consumers who purchased TYLENOL Arthritis Pain Caplet 100 count bottles with the distinctive red EZ-OPEN CAP from the lots included in this recall should stop using the product and contact McNeil for instructions on a refund or replacement.
Read the complete MedWatch 2009 Safety summary, including a link to the firm’s press release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm195704.htm
Posted 12/29/2009

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Cleviprex (clevidipine butyrate): Recall of injectable emulsion due to presence of particulate matter

Audience: Pharmacists, risk managers
The Medicines Company and FDA notified healthcare professionals of a nationwide recall of eleven lots of Cleviprex (clevidipine butyrate) injectable emulsion, indicated for treatment of hypertension, due to the potential presence of particulate matter found to be inert stainless steel particles. If the particles were to aggregate, or if larger particles were present, then they could theoretically reduce blood flow in capillaries, cause mechanical damage to some tissues, or initiate acute or chronic inflammatory reactions. Reduced blood supply to tissues may lead to ischemia or organ insufficiency in the brain, kidney, liver, heart or lungs.
See the company press release for information on specific lots affected by this recall.
Any adverse events that may be related to use should be reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program online [at www.fda.gov/MedWatch/report.htm], by phone 1-800-332-1088, or by returning the postage-paid FDA form 3500 [which may be downloaded from the MedWatch “Download Forms” page] by mail [to address on the pre-addressed form] or fax [1-800-FDA-0178].
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm194585.htmPosted 12/17/2009

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November 2009 Drug Safety Labeling Changes: 44 drugs with changes to Boxed Warning, Warnings, Contraindications, Precautions, Adverse Reactions

The MedWatch November 2009 Drug Safety Labeling Changes posting includes 44 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.

The “Summary Page” provides a listing of drug names and safety labeling sections revised: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm191946.htm

Clicking on a drug product name in the Summary View will take you to the “detailed view” page, which identifies safety labeling sections and subsections revised, along with a brief summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections.

The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and WARNINGS sections:

Actiq (fentanyl citrate)
Adenocard (adenosine)
Adenoscan (adenosine)
Avandaryl (rosiglitazone maleate and glimepiride)
Byetta (exenatide)
Cimzia (certolizumab pegol)
Cleocin HCL (clindamycin hydrochloride)
Enbrel (etanercept)
Humira (adalimumab)
Lotensin (benazepril hydrochloride)
Lotensin HCT (benazepril/hydrochlorothiazide)
Lopressor (metoprolol tartrate)
Norvir (ritonavir) capsule and solution
Parnate (tranylcypromine sulfate)
Plavix (clopidogrel bisulfate)
Qualaquin (quinine sulfate)
Rebetol (ribavirin), Soma (carisoprodol)
Remicade (infliximab)
Simponi (golimumab)
Soma Compound (carisoprodol 200 mg and aspirin 325 mg)
Soma Compound with Codeine (carisoprodol 200 mg, aspirin 325 mg and codeine phosphate 16 mg)
Tekturna (aliskiren)
Posted 12/17/2009

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Lexiva (fosamprenavir calcium) – Dear Healthcare Professional Letter

GlaxoSmithKline and FDA notified healthcare professionals of a potential association between Lexiva and myocardial infarction and dyslipidemia in HIV infected adults. GSK has modified the existing Warnings and Precautions section of the Prescribing Information to note that increases in cholesterol have occurred with treatment, the importance of lipids management, and a recommendation that triglyceride and cholesterol testing be performed prior to initiating therapy with LEXIVA and at periodic intervals during therapy. The Dear Healthcare Professional letter also provides key messages, actions required by healthcare professionals and supporting information from a case-control study reported at a February 2009 international HIV conference.
Read the complete MedWatch 2009 Safety summary, including a link to the Dear Healthcare Professional letter, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192699.htm
Posted 12/04/2009

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Norpramin (desipramine hydrochloride) – Dear Healthcare Professional Letter

Sanofi-Aventis and FDA notified healthcare professionals of changes to the Warnings and Overdosage sections of the Prescribing Information for Norpramin (desipramine hydrochloride), indicated for the treatment of depression. The new safety information states that extreme caution should be used when this drug is given to patients who have a family history of sudden death, cardiac dysrhythmias, and cardiac conduction disturbances; and that seizures precede cardiac dysrhythmias and death in some patients.
Read the complete MedWatch 2009 Safety summary, including a link to the Dear Healthcare Professional letter, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192655.htm
Posted 12/02/2009

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FDA MedWatch – December 2009 FDA Patient Safety News now available

FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals. It covers significant safety alerts and recalls for human medical products. Read the complete stories and watch or download the video program at http://www.fda.gov/psn. You may have already received notification of some of these safety issues through the MedWatch E-list. However, many of these PSN stories contain video footage and demonstrations that may be especially useful to educators in healthcare facilities and academic institutions.
Stories in the December 2009 edition include:
Boxed Warning about Tissue Injury with IV Promethazine
Intra-arterial and subcutaneous administration of promethazine are contraindicated…
Certain Philips HeartStart AEDs Recalled
Affected HeartStart FR2+ AEDs may have a memory chip failure that could make them inoperable and prevent therapy from being delivered…
Certain Unomedical Pulmonary Resuscitators Recalled
A malfunction may make it difficult to resuscitate a patient properly…
Important Changes for Heparin
Due to a change in the reference standard, the potency of heparin marketed in the U.S. will now be reduced by about 10 percent…
Medtronic Sutureless Connector Catheters Incompatible with IsoMed Pumps
The catheter may not connect completely to the pump, even if it appears to be securely connected…
Radiation Overdoses from CT Scans
FDA concerned that situation could reflect more widespread problems with CT quality assurance programs…

Reporting Adverse Events to FDA’s MedWatch
FDA’s MedWatch program relies on healthcare professionals and consumers to report to serious problems with the medical products they prescribe, dispense, or use…
Updated 12/08/2009

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FDA MedWatch – Meridia (sibutramine): Early Communication about cardiovascular events

Audience: Cardiology and endocrinology healthcare professionals
FDA notified healthcare professionals and patients that it is reviewing preliminary data from a recent study suggesting that patients using sibutramine have a higher number of cardiovascular events (heart attack, stroke, resuscitated cardiac arrest, or death) than patients using a placebo (sugar pill). Sibutramine is marketed as Meridia, a prescription drug, in the United States. Meridia was approved by FDA in 1997 for the management of obesity, including weight loss and maintenance of weight loss, in conjunction with a reduced calorie diet. Meridia is only recommended for obese patients with an initial body mass index (BMI) ≥ 30 kg/m2, or BMI ≥ 27 kg/m2 with other risk factors (e.g., diabetes, high cholesterol, controlled high blood pressure).The analysis of these data is ongoing and FDA is making no conclusions about the preliminary findings at this time. These findings highlight the importance of avoiding the use of sibutramine in patients with a history of coronary artery disease (heart disease), congestive heart failure (CHF), arrhythmias, or stroke, as recommended in the current sibutramine labeling.
Read the MedWatch safety summary, including a link to the FDA Early Communication about an Ongoing Safety Review, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm191655.htm
Posted 11/23/2009

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Cardiac Science Powerheart and CardioVive AEDs: Initial Communication-Defective components may cause affected devices to not deliver electric shocks

Audience: Cardiology healthcare professionals, hospital risk managers, biomedical engineering staff, emergency responders
Cardiac Science Corporation has received multiple complaints related to defective components in these AEDs that indicate the affected devices may not deliver electric shocks and that the devices’ self-test may not detect the defect in advance of their use. 300,000 Cardiac Science AEDs worldwide are potentially affected by this problem. The G3 Series devices were manufactured between August 2003 and August 2009. Affected models include the following:

Powerheart models 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E; and
CardioVive 92531, 92532 , and 9253

Because the AED display screen and/or audible indicators may not accurately indicate whether the device is functioning properly or will function properly at time of use, FDA encourages users of the affected AEDs to follow the additional precautions provided in this communication. FDA is gathering more data about this situation to better understand its potential public health impact and will make available any new information that might affect the use of these AED devices. Prompt reporting of adverse events can help FDA identify and better understand the risks associated with medical devices. FDA encourages anyone who suspects any electronic or mechanical problem(s) with an AED to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting Program.
Read the complete MedWatch 2009 Safety summary, including a link to the FDA Initial Communication, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm191471.htm
Posted 11/20/2009

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FDA MedWatch – Clopidogrel (marketed as Plavix) and Omeprazole (marketed as Prilosec) – Drug Interaction

Audience: Cardiovascular healthcare professionals, pharmacists
[Posted 11/17/2009] FDA notified healthcare professionals of new safety information concerning an interaction between clopidogrel (Plavix), an anti-clotting medication, and omeprazole (Prilosec/Prilosec OTC), a proton pump inhibitor (PPI) used to reduce stomach acid. New data show that when clopidogrel and omeprazole are taken together, the effectiveness of clopidogrel is reduced. Patients at risk for heart attacks or strokes who use clopidogrel to prevent blood clots will not get the full effect of this medicine if they are also taking omeprazole. Separating the dose of clopidogrel and omeprazole in time will not reduce this drug interaction.
Other drugs that are expected to have a similar effect and should be avoided in combination with clopidogrel include: cimetidine, fluconazole, ketoconazole, voriconazole, etravirine, felbamate, fluoxetine, fluvoxamine, and ticlopidine.
Recommendations for healthcare professionals are provided in the “Information for Healthcare Professionals” sheet.
Read the MedWatch safety summary, including links to the FDA Information for Healthcare Professionals sheet, Public Health Advisory, and Follow-up to the January 26, 2009 Early Communication, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm190848.htm
Posted 11/17/2009

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FDA MedWatch – October 2009 Drug Safety Labeling Changes – 26 drugs with changes to Boxed Warning, Warnings, Contraindications, Precautions, Adverse Reactions

The MedWatch October 2009 Drug Safety Labeling Changes posting includes 26 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.
The “Summary Page” provides a listing of drug names and safety labeling sections revised: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm187420.htm
Clicking on a drug product name in the Summary View will take you to the “detailed view” page, which identifies safety labeling sections and subsections revised, along with a brief summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections.
The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and WARNINGS sections:
Azulfidine (sulfasalazine), Lotrel (amlodipine besylate/benazepril hydrochloride), CellCept (mycophenolate mofetil), Hepsera (adefovir dipivoxil), Invanz (ertapenem), Invega (paliperidone), Ixempra kit (ixabepilone), MultiHance (gadobenate dimeglumine), Myfortic (mycophenolic acid), Neoral (cyclosporine), Norpramin (desipramine hydrochloride), Pulmicort Respules (budesonide), Rapamune (sirolimus), Sandimmune (cyclosporine), Viread (tenofovir disoproxil fumarate)

Posted 11/16/2009

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External Biphasic Defibrillators Energy Levels: Initial Communication

Audience: Cardiology healthcare professionals, hospital risk managers and biomedical engineering staff
Devices: External biphasic defibrillators that deliver energy levels ≤ 200 Joules (J), including monitor/defibrillators and automated external defibrillators (AEDs).
[Posted 11/10/2009] FDA notified healthcare professionals that it is investigating energy levels in external biphasic defibrillators with shocks ≤ 200 J. FDA received reports of 14 events since 2006 in which a 200 J biphasic defibrillator was ineffective in providing defibrillation/cardioversion therapy to a patient, whereas a subsequent shock from a different 360 J biphasic defibrillator resulted in immediate defibrillation/cardioversion. The majority of events occurred during attempts at cardioversion of atrial fibrillation, but there was at least one instance with defibrillation of a ventricular arrhythmia as well. Analysis of the 14 cases does not suggest the need for any change to current clinical practice, and as FDA continues its evaluation of this situation, providers are encouraged to follow the American Heart Association’s guidelines/algorithms for treatment of cardiac arrhythmias, and to follow manufacturers’ instructions for using defibrillators.
FDA is seeking additional information in order to interpret the significance of these events, and to determine whether FDA activities are advised. If you suspect a problem with a defibrillator, such as a situation where a patient received shocks from multiple devices, the problem should be reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program online [at www.fda.gov/MedWatch/report.htm], by phone 1-800-332-1088, or by returning the postage-paid FDA form 3500 [which may be downloaded from the MedWatch “Download Forms” page] by mail [to address on the pre-addressed form] or fax [1-800-FDA-0178].
Read the complete MedWatch 2009 Safety summary, including an link to the Initial Communication, at:
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm189259.htm
Posted 11/10/2009

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FDA MedWatch – November 2009 FDA Patient Safety News now available

FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals. It covers significant safety alerts, recalls, new product approvals, and offers important tips on protecting patients. Read the complete stories and watch or download the video program at http://www.fda.gov/psn. You may have already received notification of some of these safety issues through the MedWatch E-list. However, many of these PSN stories contain video footage and demonstrations that may be especially useful to educators in healthcare facilities and academic institutions.
Stories in the November 2009 edition include:
Vaccines for 2009 H1N1 Influenza
Some basics about the 2009 H1N1 vaccine…
Pedi-Cap End-Tidal CO2 Detectors Recalled
May be difficult to manually ventilate a patient or detect changes in CO2 levels…
Life-Threatening Skin Reactions with Intelence
New labeling for this HIV drug warns that the drug must be discontinued immediately if severe skin or hypersensitivity reactions develop…
Liberte Coronary Stent Now Called VeriFLEX
Name change due to mix-ups with the company’s TAXUS Liberté drug-eluting stents…
Inaccurate Readings with Philips Avalon Fetal Monitors
Inaccuracies include halving or doubling of the fetal heart rate, and switching between the fetal and maternal heart rates…
Pure Red Cell Aplasia with Cellcept and Myfortic
Reducing the dose or stopping the drug may reverse the aplasia, but reducing immunosuppression in transplant patients could place the graft at risk.…
Recall of ConMed Linvatec Surgical Handpieces and Cables
Switch problems may cause certain models to self-activate, continue to run after the trigger is released, or to run in the wrong direction…
TNF Blockers and Cancer in Children
Updated boxed warning for Remicade, Enbrel, Humira, Cimzia, and Simponi…
Portex Uncuffed Pediatric Tracheal Tubes Recalled
Defect could increase airway resistance, and compromise the ability to ventilate a patient…
Safety Concerns with Philips Medical Alert Pendants
Emergency help buttons worn around the neck may pose a choking hazard if the cord becomes entangled…
For more FDA Patient Safety News, visit http://www.fda.gov/psn . Please send any comments, questions or suggestions about the program to PSNews@fda.gov
Posted 11/03/2009

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Byetta (exenatide) – Renal Failure
Audience: Endocrine and nephrology healthcare professionals
FDA notified healthcare professionals of revisions to the prescribing information for Byetta (exenatide) to include information on post-marketing reports of altered kidney function, including acute renal failure and insufficiency. Byetta, an incretin-mimetic, is approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
From April 2005 through October 2008, FDA received 78 cases of altered kidney function (62 cases of acute renal failure and 16 cases of renal insufficiency), in patients using Byetta. Some cases occurred in patients with pre-existing kidney disease or in patients with one or more risk factors for developing kidney problems. Labeling changes include:

Information regarding post-market reports of acute renal failure and insufficiency, highlighting that Byetta should not be used in patients with severe renal impairment (creatinine clearance <30 ml/min) or end-stage renal disease.
Recommendations to healthcare professionals that caution should be applied when initiating or increasing doses of Byetta from 5 mcg to 10 mcg in patients with moderate renal impairment (creatinine clearance 30 to 50 ml/min).
Recommendations that healthcare professionals monitor patients carefully for the development of kidney dysfunction, and evaluate the continued need for Byetta if kidney dysfunction is suspected while using the product.
Information about kidney dysfunction in the patient Medication Guide to help patients understand the benefits and potential risks associated with Byetta.

Read the complete MedWatch 2009 safety summary, including a link to the Healthcare Professional information sheet, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm188703.htm
Posted 11/03/2009

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FDA Medwatch – Accusure Insulin Syringes (Qualitest Pharm) – Nationwide recall of all lots due to potential for needle to become detached from syringe

Accusure Insulin Syringes (Qualitest Pharmaceuticals) – Recall
Audience: Diabetes healthcare professionals and patients
Qualitest Pharmaceuticals and FDA notified healthcare professionals of a nationwide recall of Accusure Insulin Syringes. All syringes, regardless of lot number, are subject to this recall. These syringes were distributed between January 2002 and October 2009 to wholesale and retail pharmacies nationwide (including Puerto Rico). The syringes in these lots may have needles which detach from the syringe. If the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into to the syringe, or remain in the skin after injection. Consumers who have any Accusure insulin syringes should stop using them and contact Qualitest at 1-800-444-4011 for reimbursement.
Read the complete MedWatch 2009 Safety summary, including a link to the firm’s press release and previous August 2009 recall, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm188151.htm

Posted 10/28/2009

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FDA Medwatch – Peramivir IV

Audience: Infectious disease healthcare professionals, hospital risk managers
FDA notified healthcare professionals that, in response to a request from the U.S. Centers for Disease Control and Prevention, it has issued an emergency use authorization (EUA) for the investigational antiviral drug peramivir intravenous in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza infection who are admitted to a hospital. IV peramivir is authorized only for hospitalized adult and pediatric patients for whom therapy with an IV drug is clinically appropriate, based on one or more of the following: 1] the patient is not responding to either oral or inhaled antiviral therapy, 2] when drug delivery by a route other than an intravenous route is not expected to be dependable or feasible, or 3] for adults only, when the clinician judges IV therapy is appropriate due to other circumstances.
Given there are limited safety data on peramivir, mandatory reporting requirements are important to defining the safety profile of this unapproved drug. As part of the conditions of the EUA, health care providers (or designee) must report adverse events and all medication errors associated with peramivir to FDA’s MedWatch program within 7 calendar days from the onset of the adverse event. Additionally, healthcare providers (or designee) must conduct follow-up requested by FDA or CDC related to peramivir adverse event or medication error reports submitted to FDA.
Read the complete MedWatch 2009 Safety summary, including links to the Information for Healthcare Professionals and FDA News Release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm187814.htm
Posted 10/26/2009

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FDA MedWatch – September 2009 Drug Safety Labeling Changes – 36 drugs with changes to Boxed Warning, Warnings, Contraindications, Precautions, Adverse Reactions

The MedWatch September 2009 Drug Safety Labeling Changes posting includes 36 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.
The “Summary Page” provides a listing of drug names and safety labeling sections revised: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm183107.htm
Clicking on a drug product name in the Summary View will take you to the “detailed view” page, which identifies safety labeling sections and subsections revised, along with a brief summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections.
The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and WARNINGS sections:
AndroGel (testosterone gel), Rapamune (sirolimus), Testim (testosterone gel), Cordarone (amiodarone HCl), Flector Patch (diclofenac epolamine), Intelence (etravirine), Kayexalate (sodium polystyrene sulfonate), Lexiva (fosamprenavir calcium), Neoral (cyclosporine capsules, modified), Ortho Evra (norelgestromin/ethinyl estradiol) transdermal system, Pre-Pen (benzylpenicilloyl polylysine), Sustiva (efavirenz), Ultracet (tramadol HCl/acetaminophen), Ultram (tramadol hydrochloride), Voltaren Gel (diclofenac sodium), Zolinza (vorinostat).
Posted 10/16/2009

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FDA MedWatch – Medical Device Power Cords Safety Investigation: Initial Communication

Audience: Healthcare professionals, patients/caregivers
[Posted 10/19/2009] FDA is investigating whether certain types of power cords used with medical devices may be defective. Two medical device manufacturers (Hospira, Inc. and Abbott Nutrition) have sent FDA 122 reports of sparking, charring, and fires from the power cords used with their devices. The companies’ investigations of these reports determined that the power cord’s prongs may crack and fail at/or inside the plug. The potential risks from this power cord failure include electrical shock, delay in setup and therapy, interruption of therapy, device failure, and fires. Depending on the device and therapy, these failures may potentially lead to serious adverse health consequences, including death.
All the reports received so far from Hospira and Abbott have involved AC power cords with a black plastic bridge manufactured by the Electri-cord Manufacturing Company. FDA is aware that Electri-cord has supplied the affected power cords to other medical device manufacturers.The agency is now attempting to determine which devices may be equipped with these cords.
FDA recommends that all users of medical devices, either in healthcare facilities or in the home, closely monitor the wear and tear on the electric cords used to power these devices. This vigilance is especially important in oxygen rich environments, in which electrical sparking and arcing may trigger a fire.
Read the MedWatch safety summary, including a link to the FDA Initial Communication, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm187117.htm
Posted 10/16/2009

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Dexferrum (iron dextran injection) – Labeling change

Audience: Hematological healthcare professionals, hospital risk managers
American Regent and FDA notified healthcare professionals that anaphylactic-type reactions, including fatalities, have followed the parenteral administration of iron dextran injection. The Boxed Warninghas been modified to recommend administering a test dose prior to the first therapeutic dose and observing for signs or symptoms of anaphylactic-type reactions during administration of Dexferrum. Fatal reactions have followed the test dose of iron dextran injection, even in situations where the test dose was tolerated. Patients with a history of drug allergy or multiple drug allergies may be at increased risk of anaphylactic-type reactions. It is recommended that resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions be readily available during Dexferrum administration.
Read the complete MedWatch 2009 Safety summary, including links to the Dear Healthcare professional letter and the revised prescribing information, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm186899.htm
Posted 10/16/2009

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FDA MedWatch – Relenza (zanamivir) Inhalation Powder must not be reconstituted in liquid formulation or used in any nebulizer or mechanical ventilator

Audience: Infectious disease healthcare professionals, hospital risk managers
[Posted 10/09/2009] GlaxoSmithKline (GSK) and FDA notified healthcare professionals of a report of the death of a patient with influenza who received Relenza (zanamivir) Inhalation Powder which was solubilized and administered by mechanical ventilation. Relenza (zanamivir) Inhalation Powder is not intended to be reconstituted in any liquid formulation and is not recommended for use in any nebulizer or mechanical ventilator.
GSK is aware that Relenza Inhalation Powder is being removed from its FDA-approved packaging and dissolved in various solutions for the purpose of nebulizing zanamivir for inhalation by patients with influenza who are unable to take oral medications or unable to inhale Relenza Inhalation Powder using the Diskhaler. Relenza or zanamivir for nebulization have not been approved by the FDA. The safety, effectiveness, and stability of zanamivir use by nebulization have not been established.
Relenza Inhalation Powder should only be used as directed in the prescribing information by using the Diskhaler device provided with the drug product. Relenza Inhalation Powder is a mixture of zanamivir active drug substance and lactose drug carrier. This formulation is not designed or intended to be administered by nebulization. There is a risk that the lactose sugar in this formulation can obstruct proper functioning of mechanical ventilator equipment.
Read the MedWatch safety summary, including a link to the Dear Healthcare Professional Letter, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm186081.htm
Posted 10/14/2009

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FDA MedWatch – Philips Heartstart Fr2+ Automated External Defibrillators – Recall

Audience: Fire departments, emergency medical services personnel, hospitals
Philips and FDA notified healthcare professionals of the recall of 5,400 HeartStart FR2+ automated external defibrillators (AED) due to reports of a memory chip failure which could render the AED inoperable and prevent it from delivering therapy when indicated. The AEDs are used by trained responders and designated response teams to help treat sudden cardiac arrest.
The recalled units (models M3860A and M3861A, distributed by Philips; and models M3840A and M3841A, distributed by Laerdal Medical) were manufactured between May, 2007 and January, 2008. Philips is contacting customers to arrange for the return and replacement of all the recalled AEDs and set up a page on the Philips Web site — www.philips.com/FR2PlusAction — with a serial number look-up tool to allow customers to find out if their FR2+ is part of this recall, as well as instructions on what to do if it is.
Read the complete MedWatch 2009 Safety summary, including a link to the firm’s press release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm185179.htm
Posted 10/06/2009

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FDA MedWatch – October 2009 FDA Patient Safety News now available

FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals. It covers significant safety alerts, recalls, new product approvals, and offers important tips on protecting patients. Read the complete stories and watch or download the video program at http://www.fda.gov/psn. You may have already received notification of some of these safety issues through the MedWatch E-list. However, many of these PSN stories contain video footage and demonstrations that may be especially useful to educators in healthcare facilities and academic institutions.
Stories in the October 2009 edition include:
New Colchicine Product and Dosing Regimen
FDA has approved Colcrys, the first single-ingredient oral colchicine product…
Potentially Fatal Errors with Certain Glucose Test Strips
GDH-PQQ test strips cannot distinguish between glucose and other sugars contained in certain therapeutic products…
Certain Lots of Teva Propofol Recalled
Vials in these lots may contain elevated endotoxin levels…
Alaris (Medley) Infusion Systems Recalled
Affected devices may cause patients to be over or under-infused, leading to serious injury or death…
Recall of Certain Hospira Devices
Defective cords may pose risk of fire, electric shock…
“Nuby” Gel-filled Teethers Recalled
Gel inside teethers may be contaminated with bacteria…
Safety Warning on Certain Body-building Products
Consumers should immediately stop taking any product that claims to contain steroids or steroid-like substances…
For more FDA Patient Safety News, visit http://www.fda.gov/psn . Please send any comments, questions or suggestions about the program to PSNews@fda.gov Posted 10/05/2009

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FDA MedWatch – Heparin: Change in Reference Standard – The change will result in 10% reduction in the potency of the heparin marketed in the U.S.

Heparin: Change in Reference Standard
Audience: Pharmacists, physicians, hospital risk managers and consumers
FDA notified healthcare professionals and patients of a change to heparin, effective October 1, 2009, which will include a new reference standard and test method used to determine the potency of the drug and able to detect impurities that may be present in heparin. The change, which will also harmonize the USP unit dose with the WHO International Standard unit dose, will result in approximately a 10% reduction in the potency of the heparin marketed in the United States.
This may have clinical significance in some situations, such as when heparin is administered as a bolus intravenous dose and an immediate anticoagulant effect is clinically important. Healthcare providers should be aware of the decrease in heparin potency as they monitor the anticoagulant effect of the drug; more heparin may be required to achieve and maintain the desired level of anticoagulation in some patients.
There will be simultaneous availability of heparin manufactured to meet the “old” and “new” USP monograph, with potential differences in potency. Products using the new “USP unit” potency definition are anticipated to be available on or after October 8. FDA is working with the manufacturers of heparin to ensure that an appropriate identifier is placed on heparin made under the new USP monograph. Most manufacturers will place an “N” next to the lot number. FDA is also working with the heparin manufacturers to study the impact of this variation in potency and will make the results available when the studies have concluded.
Read the complete MedWatch 2009 Safety summary, including links to the Public Health Alert and Information for Patients, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm184687.htm

Posted 10/1/2009

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FDA MedWatch – Children’s and Infants’ Tylenol Oral Suspension Products – Recall

Audience: Consumers and Healthcare professionals
McNeil Consumer Healthcare and FDA notified consumers of a nationwide recall of certain Tylenol products as a precautionary measure because of potential manufacturing problems. The company initiated a recall of certain oral suspension products distributed between March 2008 and May 2008 due to the potential of bacteria in raw materials used to manufacture the finished product. There are no illnesses reported by patients using this product. The full list of recalled product lots can be accessed on the company’s website at
http://www.tylenolprofessional.com/assets/TYLENOL_Letter_091809.pdf.
McNeil is advising parents and caregivers who have administered affected product to their child or infant and have concerns to contact their healthcare providers. Parents and caregivers can find the lot numbers on the bottom of the box containing the product and also on the sticker that surrounds the product bottle.
Read the complete MedWatch 2009 Safety summary including a link to the FDA news release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm183924.htm
Posted 09/28/2009

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FDA MedWatch – Tamiflu (oseltamivir) for Oral Suspension: Potential Medication Errors

Audience: Pharmacists, pediatrics healthcare professionals
FDA issued a Public Health Alert to notify prescribers and pharmacists about potential dosing errors with Tamiflu (oseltamivir) for Oral Suspension. U.S. health care providers usually write prescriptions for liquid medicines in milliliters (mL) or teaspoons, while Tamiflu is dosed in milligrams (mg). The dosing dispenser packaged with Tamiflu has markings only in 30, 45 and 60 mg. The Agency has received reports of errors where dosing instructions for the patient do not match the dosing dispenser. Health care providers should write doses in mg if the dosing dispenser with the drug is in mg. Pharmacists should ensure that the units of measure on the prescription instructions match the dosing device provided with the drug.
Read the complete MedWatch 2009 Safety summary, including links to the FDA Public Health alert, Dear Healthcare Professional letter [Roche] and Information for Pharmacists [CDC], at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm183714.htm
Posted 09/28/2009

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FDA MedWatch – Sitagliptin (marketed as Januvia and Janumet) – acute pancreatitis

Audience: Diabetes healthcare professionals, patients
FDA notified healthcare professionals and patients of revisions to the prescribing information for Januvia (sitagliptin) and Janumet (sitagliptin/metformin) to include information on reported cases of acute pancreatitis in patients using these products. Eighty-eight post-marketing cases of acute pancreatitis, including two cases of hemorrhagic or necrotizing pancreatitis in patients using sitagliptin, were reported to the Agency between October 2006 and February 2009. It is recommended that healthcare professionals monitor patients carefully for the development of pancreatitis after initiation or dose increases of sitagliptin or sitagliptin/metformin. Sitagliptin has not been studied in patients with a history of pancreatitis. Therefore, it is not known whether these patients are at an increased risk for developing pancreatitis and the medication should be used with caution and with appropriate monitoring in patients with a history of pancreatitis. Considerations for healthcare professionals, information for patients, and a Data Summary are provided.
Read the complete MedWatch 2009 Safety summary including a link to the Information for Healthcare Professionals sheet, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm183800.htm
Posted 09/28/2009

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FDA MedWatch – LIFEPAK CR Plus Automated External Defibrillators (Physio-Control, Inc)

Audience: Emergency medical personnel, consumers
FDA notified healthcare professionals of a Class I recall of certain LIFEPAK CR Plus Automated External Defibrillators (AED) manufactured and distributed from July 9, 2008 through August 19, 2008. An extremely humid environment may cause the affected devices to improperly analyze the heart rhythm and may cause the device to delay or fail to deliver therapy.
Any adverse events or quality problems that may be related to the use of this product should be reported to the FDA’s MedWatch Adverse Event Reporting program online, by phone [1-800-332-1088], or by returning the postage-paid FDA Form 3500 by mail or fax [1-800-FDA-0178].
Read the complete MedWatch 2009 Safety summary, including a link to the Class 1 recall notice, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm182496.htm
Posted 09/16/2009

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FDA MedWatch – Promethazine Hydrochloride Injection

Audience: All healthcare professionals
FDA notified healthcare professionals that a Boxed Warning is being added to the prescribing information for Promethazine Hydrochloride products, describing the risks of severe tissue injury, including gangrene, requiring amputation following intravenous administration of promethazine. The Boxed Warning will remind practitioners that due to the risks of intravenous injection, the preferred route of administration is deep intramuscular injection and that subcutaneous injection is contraindicated.
Perivascular extravasation, unintentional intra-arterial injection and intraneuronal or perineuronal infiltration of the drug may result in irritation and tissue damage. Healthcare professionals should be alert for signs and symptoms of potential tissue injury including burning or pain at the site of injection, phlebitis, swelling, and blistering.
Read the complete MedWatch 2009 Safety summary including links to the Information for Healthcare Professionals sheet and News Release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm182500.htm
Posted 09/16/2009

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FDA MedWatch – August 2009 Drug Safety Labeling Changes – 35 drugs with changes to Boxed Warning, Warnings, Contraindications, Precautions, Adverse Reactions

The MedWatch August 2009 Drug Safety Labeling Changes posting includes 35 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.
The “Summary Page” provides a listing of drug names and safety labeling sections revised: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm181141.htm
Clicking on a drug product name in the Summary View will take you to the “detailed view” page, which identifies safety labeling sections and subsections revised, along with a brief summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections.
The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and WARNINGS sections:
DexFerrum (iron dextran), INFeD (iron dextran), Tasigna (nilotinib), Arixtra (fondaparinux sodium), Flagyl (metronidazole), Inomax (nitric oxide), Lariam (mefloquine hydrochloride), Letairis (ambrisentan), Lopressor HCT (metoprolol tartrate and hydrochlorothiazide), Merrem (meropenem), Primaxin (imipenem and cilastatin), Pristiq (desvenlafaxine), Tobramycin, Zoladex (goserelin acetate).

Posted 09/15/2009

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FDA MedWatch – Myfortic (mycophenolic acid)

Audience: Renal, cardiac, and hepatic transplantation healthcare professionals
Novartis and FDA notified healthcare professionals that cases of Pure Red Cell Aplasia (PRCA) have been reported in patients treated with Myfortic. The WARNINGS and ADVERSE REACTIONS sections of the Myfortic Prescribing Information have been revised to reflect this new safety information.
PRCA is a type of anemia in which there is a selective reduction of red blood cell precursors on bone marrow examination. Patients with PRCA may present with fatigue, lethargy, and/or abnormal paleness of the skin (pallor). In some cases, PRCA was found to be reversible with dose reduction or cessation of Myfortic therapy. In transplant patients, however, reduced immunosuppression may place the graft at risk.
Read the complete MedWatch Safety summmary (corrected) at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm181306.htm
Posted 09/08/2009

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FDA MedWatch – Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi) Updated

Audience: Rheumatologists, gastroenterologists, oncologists, dermatologists
[UPDATED 08/31/2009] Supplemental Q&As added.
[Original Posting 08/04/2009] FDA notified healthcare professionals that it has completed its analysis of tumor necrosis factor (TNF) blockers and has concluded that there is an increased risk of lymphoma and other cancers associated with the use of these drugs in children and adolescents. This new safety information is now being added to the Boxed Warning for these products. FDA has also identified new safety information related to the occurrence of leukemia and new-onset psoriasis in patients treated with TNF blockers. The current prescribing information for TNF blockers does contain a warning for malignancies, but does not specifically mention leukemia. FDA is also requiring updates to the current Medication Guide to help patients understand the risks associated with TNF blocker therapy.
Read the complete MedWatch 2009 Safety summary including the Update of Q&A’s that provide supplemental information to the original August 4, 2009 safety alert, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm175843.htm
Posted 09/01/2009

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FDA MedWatch – September 2009 FDA Patient Safety News is now available
FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals. It covers significant safety alerts, recalls, new product approvals, and offers important tips on protecting patients. Read the complete stories and watch or download the video program at http://www.fda.gov/psn. You may have already received notification of some of these safety issues through the MedWatch E-list. However, many of these PSN stories contain video footage and demonstrations that may be especially useful to educators in healthcare facilities and academic institutions.
Stories in the September 2009 edition include:
New Warnings on Propoxyphene Overdoses
Danger of overdosing if drugs such as Darvon and Darvocet are taken at higher than recommended doses…
Fire Hazard with Stabilet Infant Warmers
Recalled warmers should be taken out of service as soon as possible…
Warning on Neuropsychiatric Effects from Smoking Cessation Drugs
Risk of serious neuropsychiatric effects with Chantix (varenicline) and Zyban (bupropion)…
Nephropathy with Certain Organ Transplant Drugs
Risk of BK virus-associated nephropathy, primarily seen in kidney transplant patients…
Recall of Medtronic Mini-Med Paradigm Quick-Set Infusion Sets
Patients who have the recalled infusion sets from affected lots should stop using them and return them to Medtronic for replacement…
Possible Cancer Risk with Lantus
Observational studies suggest an increased cancer risk associated with Lantus (insulin glargine)…
FDA Studying Cleaning Procedures for Arthroscopic Shavers
FDA is asking facilities that find tissue in these devices after they have been cleaned according to the manufacturer’s instructions to report through FDA’s MedWatch program…
Update on Cefepime Safety Data
FDA’s further analysis has not found an increased death rate in patients taking cefepime, sold as Maxipime and generics…
Preventing Skin Burns from Surgical Microscopes
Infants, the elderly and those with poor circulation can be particularly vulnerable to skin burns…
Patient Deaths from Injection of Topical Epinephrine
ISMP recommendations to help prevent these potentially fatal mix-ups…

Posted 08/31/2009

*Update to Previous Post*
FDA MedWatch – Levemir Insulin (Novo Nordisk)
Audience: Patients, pharmacists, diabetes healthcare professionals
[UPDATED 08/26/2009] FDA is reminding the public that stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. still may be on the market. Evidence gathered to date suggests that the stolen insulin was not stored and handled properly and may be dangerous for people to use. FDA has received multiple reports of patients who suffered an adverse event due to poor control of glucose levels after using a vial from one of the stolen lots.
Read the complete MedWatch 2009 Safety summmary including a link to the FDA News release and the original June 13,2009 alerts at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm166359.htm
Posted 08/27/2009

FDA MedWatch – 38 drugs with changes to Boxed Warning, Warnings, Contraindications, Precautions, Adverse Reactions
The MedWatch July 2009 Drug Safety Labeling Changes posting includes 38 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.
The “Summary Page” provides a listing of drug names and safety labeling sections revised:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm172740.htm
Clicking on a drug product name in the Summary View will take you to the “detailed view” page, which identifies safety labeling sections and subsections revised, along with a brief summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections.
The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and WARNINGS sections:
Chantix (varenicline), Wellbutrin (bupropion hydrochloride), Zyban (bupropion hydrochloride), Diabeta (glyburide), Lopid (gemfibrozil), Ortho Evra (norelgestromin/ethinyl estradiol) transdermal system, Veramyst (fluticasone furoate), Actonel (risedronate sodium), Gardasil (Human Papillomavirus Quadrivalent Types 6, 11, 16, 18) Recombinant Vaccine, Letairis (ambrisentan), Myfortic (mycophenolic acid), Rilutek (riluzole), Soliris (eculizumab) Posted 08/27/2009

FDA MedWatch – Orlistat (marketed as Alli and Xenical): Early Communication about an Ongoing Safety Review
Audience: Endocrinological healthcare professionals, patients
FDA notified healthcare professionals and patients that it is reviewing new safety information regarding reports of liver-related adverse events in patients taking orlistat. Orlistat is marketed in the United States as a prescription product, Xenical, and as an over-the-counter (OTC) product, Alli. Between 1999 and October 2008, 32 reports of serious liver injury, including 6 cases of liver failure, in patients using orlistat were submitted to FDA’s Adverse Event Reporting System. The most commonly reported adverse events described in the 32 reports of serious liver injury were jaundice, weakness, and abdominal pain. FDA is reviewing other data on suspected cases of liver injury submitted by the manufacturers of orlistat, analysis of these data is ongoing and no definite association between liver injury and orlistat has been established at this time. FDA is not advising healthcare professionals to change their prescribing practices with orlistat. Consumers currently taking Xenical should continue to take it as prescribed and those using over-the-counter Alli should continue to use the product as directed.
FDA urges both healthcare professionals and consumers to report side effects from the use of orlistat (Alli and Xenical) to FDA’s MedWatch Adverse Event Reporting program.
Read the complete MedWatch Safety summary, including links to the Early Communication and FDA News Release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm180025.htm

Posted 08/25/2009

FDA MedWatch – Accusure Insulin Syringes [31G, 1/2 cc and 1 cc]
Audience: Patients with diabetes mellitus, pharmacists and diabetes healthcare professionals
Qualitest Pharmaceuticals and FDA notified patients and healthcare professionals of a voluntary nationwide recall of two lots of Accusure Insulin Syringes. The syringes in these lots have been found to have needles which can detach from the syringe. When the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into the syringe, or remain in the skin after an injection. Consumers who have any recalled Accusure Insulin Syringes (31 G –Short Needle-either 1/2 cc or 1 cc, lot number 6JCB1 or lot number 7CPT1) should stop using them and contact Qualitest at 1-800-444-4011 for product replacement instructions. The lot number can be found on the white paper backing of each individual syringe. These recalled products were distributed from January 2007 through June 2008 to wholesalers and retail pharmacies nationwide (including Puerto Rico).
Read the complete MedWatch 2009 Safety summmary including a link to the firm press release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm179955.htm

Posted 08/24/2009

FDA MedWatch – Ibuprofen (Unapproved) topical drug products
Audience: Consumers, pharmacists
FDA informed consumers and healthcare professionals of its intent to take action against eight companies that market unlawful over-the-counter (OTC) topical drug products containing the pain reliever ibuprofen. The products, which contain ibuprofen in combination with a variety of other active ingredients and are marketed for pain relief, are unapproved new drugs that require an approved new drug application in order to be legally marketed. Orally administered ibuprofen has been approved as a safe and effective treatment for pain and inflammation. There are no approved applications for topical ibuprofen products. Topical ibuprofen is often promoted as a “safer” alternative that can be used in place of oral ibuprofen because of certain side effects, such as stomach ulcers and cardiovascular effects that are associated with prolonged use of oral ibuprofen. However, these safety claims for topical ibuprofen have not been reviewed by the FDA, nor has the agency evaluated what side effects might be associated with such products.
The names of the products and manufacturers that received warning letters are:
Emuprofen (Progressive Emu, Inc.)
BioEntopic 15% Ibuprofen Crème (BioCentric Laboratories, Inc.)
Ibunex Topical Ibuprofen (Core Products International, Inc.)
LoPain AF 15% Ibuprofen Crème (Geromatrix Health Products)
IB-RELIEF (MEKT LLC)
Profen HP (Ridge Medical Products)
IbuPRO-10 Plus (Meditrend, Inc. dba Progena Professional Formulations)
IBU-RELIEF 12 (Wonder Laboratories)
Read the complete MedWatch 2009 Safety summary including a link to the FDA press release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm179925.htm
Posted 08/21/2009

FDA Medwatch – Hospira, Inc. Device Recall
Audience: Hospital Risk Managers
[Posted 08/17/2009] Hospira and FDA notified healthcare professionals and patients of a nationwide recall of devices that have defective AC power cords in response to customer reports of sparking, charring and fires on the plug of the power cord. Hospira’s investigation of these reports determined that the power cord’s prongs may crack and fail at or inside the plug. The potential risks from this power cord failure include electrical shock, delay in setup and therapy, interruption of therapy, device failure, and fires which may also occur in an oxygen-rich environment. Depending on the device and therapy, these failures may lead to potential serious injury or death.
Users with affected power cords that have bent or cracked prongs, burnt plastic or excessive wear and tear should discontinue use immediately and contact their Hospira sales representative or Hospira Technical Support Operations at 1-800-241-4002 (available from 6 a.m. to 4 p.m., Pacific time) for instructions on receiving replacement parts or devices.
For a list of the recalled devices
http://www.fda.gov/Safety/Recalls/ucm178158.htm
Read the complete MedWatch 2009 Safety summary, including a link to the firm press release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm179004.htm
Posted 08/17/2009

FDA MedWatch – CellCept (mycophenolate mofetil) – cases of Pure Red Cell Aplasia reported in patients treated with CellCept
FDA and Roche notified healthcare professionals that cases of Pure Red Cell Aplasia (PRCA) have been reported in patients treated with CellCept. The WARNINGS and ADVERSE REACTIONS sections of the CellCept Prescribing Information have been revised to reflect this new safety information.
PRCA is a type of anemia in which there is a selective reduction of red blood cell precursors on bone marrow examination. Patients with PRCA may present with fatigue, lethargy, and/or abnormal paleness of the skin (pallor). In some cases, PRCA was found to be reversible with dose reduction or cessation of CellCept therapy. In transplant patients, however, reduced immunosuppression may place the graft at risk.
Read the MedWatch safety summary, including links to the Dear Healthcare Professional Letter and revised Prescribing Information, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm177397.htm
Posted 08/14/2009

FDA MedWatch – GDH-PQQ Glucose Monitoring Technology: possibility of falsely elevated blood glucose results
[Posted 08/13/2009] FDA notified healthcare professionals of the possibility of falsely elevated blood glucose results when using GDH-PQQ glucose test strips on patients who are receiving therapeutic products containing certain non-glucose sugars. These sugars can falsely elevate glucose results, which may mask significant hypoglycemia or prompt excessive insulin administration, leading to serious injury or death.
GDH-PQQ glucose monitoring measures a patient’s blood glucose value using methodology that cannot distinguish between glucose and other sugars. Certain non-glucose sugars, including maltose, xylose, and galactose, are found in certain drug and biologic formulations, or can result from the metabolism of a drug or therapeutic product. The FDA Public Health Notification provides a list of GDH-PQQ Glucose Test Strips and recommends that healthcare practitioners avoid using GDH-PQQ glucose test strips in healthcare facilities or take steps to never use them on patients receiving interfering substances.
FDA encourages the voluntary reporting of any medical device adverse events related to glucose meters or glucose test strips that do not meet the requirements for mandatory reporting. Adverse events should be reported to the FDA’s MedWatch Adverse Event Reporting program online, by phone [1-800-332-1088], or by returning the postage-paid FDA Form 3500 by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA-0178].
Read the complete MedWatch 2009 Safety summary, including links to the Public Health Notification and Advice for Patients, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm177295.htm
Posted 08/04/2009

August 2009 FDA Patient Safety News is now available
FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals. It covers significant safety alerts, recalls, new product approvals, and offers important tips on protecting patients. Read the complete stories and watch or download the video program at http://www.fda.gov/psn. You may have already received notification of some of these safety issues through the MedWatch E-list. However, many of these PSN stories contain video footage and demonstrations that may be especially useful to educators in healthcare facilities and academic institutions.

Stories in the August 2009 edition include:

Liver Failure with Propylthiouracil
Certain patients, and especially children, should only be treated with the anti-thyroid propylthiouracil if they cannot take methimazole…

Neuropsychiatric Events with Certain Asthma Drugs
Precautions added to the labeling of the leukotriene modifiers drugs Accolate, Zyflo, Zyflo CR, and Singulair on the possibility of neuropsychiatric events…

Recall of Certain Infant Apnea Monitors
SmartMonitor 2, Models 4002 and 4003 with specific serial numbers may fail to alarm if the infant experiences breathing problems or an abnormal heart rate…

Alert on Stolen Levemir Insulin
Stolen Levemir may be dangerous to use, so patients should check their supply…

Serious Fungal Infections with Simponi
Simponi, like other immunosuppressant drugs used to treat chronic inflammatory diseases, should be discontinued if infections such as histoplasmosis occur…

Practicing Hospital Bed Safety
Avoid patient entrapment and electrical fires when using hospital beds in health care facilities and at home…

Antiepileptic Drugs and Suicidality
Closely monitor all patients starting or taking antiepileptic drugs for changes in behavior…

Increased Mortality with Rapamune in Liver Transplants
Safety and efficacy of Rapamune (sirolimus) have not been established in liver or lung transplant patients…

Certain Skin Sanitizers/Protectants Contaminated
Recall of certain skin care products made by Clarcon Biological Chemistry Laboratory due to high levels of bacteria…

Intranasal Zinc May Cause Loss of Smell
FDA is advising patients not to use Zicam Cold Remedy Nasal products that are administered directly into the nose…
Posted 08/04/2009

The MedWatch June 2009 Drug Safety Labeling Changes posting includes 31 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.
The “Summary Page” provides a listing of drug names and safety labeling sections revised: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm153825.htm
Clicking on a drug product name in the Summary View will take you to the “detailed view” page, which identifies safety labeling sections and subsections revised, along with a brief summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections.
The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and WARNINGS sections:
Prometrium (progesterone), Reglan (metoclopramide), Coreg (carvedilol), Prandin (repaglinide), Videx (didanosine), Amaryl (glimepiride), Aristospan (triamcinolone hexacetonide injectable suspension, USP), Cancidas (caspofungin acetate), CellCept (mycophenolate mofetil), Combivent (ipratropium bromide and albuterol sulfate), Coreg CR (carvedilol phosphate), Patanase (olopatadine hydrochloride), Rocephin (ceftriaxone sodium), Strattera (atomoxetine hydrochloride) Posted 7/15/2009

Sirolimus (marketed as Rapamune), Cyclosporine (marketed as Sandimmune and generics), Cyclosporine modified (marketed as Neoral and generics), Mycophenolate mofetil (marketed as Cellcept and generics), Mycophenolic acid (marketed as Myfortic)
Audience: Transplant and nephrology healthcare professionals
The FDA is requiring the makers of certain immunosuppressant drugs to update their labeling to reflect that immunosuppressed patients are at increased risk for opportunistic infections, such as activation of latent viral infections, including BK virus-associated nephropathy. These immunosuppressant drugs are used to protect against the rejection of certain organ transplants. The association of BK virus-associated nephropathy has previously been reported for another immunosuppressant drug, tacrolimus (marketed as Prograf). Monitoring for this serious risk and early intervention by the health care provider is critical. Adjustments in immunosuppression therapy should be considered for patients who develop BK virus-associated nephropathy.
Read the MedWatch safety summary, including a link to the FDA “Information for Healthcare Professionals” page, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm171828.htm
Posted 7/14/2009

Medtronic Paradigm Quick-Set Infusion Sets
Audience: Diabetes healthcare professionals, patients
Medtronic, Inc. and FDA notified healthcare professionals and patients of a recall of Quick-set infusion sets that are used with MiniMed Paradigm insulin pumps because the affected infusion sets may not allow the insulin pump to vent air pressure properly. This could potentially result in the device delivering too much or too little insulin and may lead to serious injury or death. An infusion set is a thin plastic tube used to deliver insulin from an insulin pump to a diabetes patient, and is typically replaced by the patient every three days. Affected infusion sets are reference numbers MMT-396, MMT-397, MMT-398 and MMT-399 with lot numbers starting with the number “8″. Patients should discontinue using “Lot 8” Quick-set infusion sets. The lot number (for example 8XXXXXX) is clearly marked on both the product box label, and on each individual infusion set package. Customers are being asked to return any affected infusion sets to the company.
Read the complete MedWatch Safety summary, including a link to the firm press release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm171686.htm

Posted 7/14/2009

MedWatch – Propoxyphene-containing Products: FDA taking actions to reduce risk of overdose because of data linking propoxyphene and fatal overdoses
Propoxyphene-containing Products
Audience: Pharmacists, Pain management healthcare professionals
FDA notified healthcare professionals that it is taking several actions to reduce the risk of overdose in patients using pain medications that contain propoxyphene because of data linking propoxyphene and fatal overdoses. The agency will require manufacturers of propoxyphene-containing products to strengthen the label, including the boxed warning, emphasizing the potential for overdose when using these products and to provide a medication guide to patients stressing the importance of using the drugs as directed.
FDA is requiring a new safety study assessing unanswered questions about the effects of propoxyphene on the heart at higher than recommended doses. Findings from this study, as well as other data, could lead to additional regulatory action. To further evaluate the safety of propoxyphene, FDA plans to work with several groups including the Centers for Medicare & Medicaid Services and the Veterans Health Administration to study how often the elderly are prescribed propoxyphene instead of other pain relievers and the difference in the safety profiles of propoxyphene compared to other drugs.
Read the complete MedWatch Safety summary, including links to the FDA news release and Q&A’s, at:
www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm170763.htm

Posted 7/7/2009

FDA MedWatch – July 2009 Patient Safety News now available
FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals. It covers significant safety alerts, recalls, new product approvals, and offers important tips on protecting patients. Read the complete stories and watch or download the video program at http://www.fda.gov/psn. You may have already received notification of some of these safety issues through the MedWatch E-list. However, many of these PSN stories contain video footage and demonstrations that may be especially useful to educators in healthcare facilities and academic institutions.
Stories in the July 2009 edition include:
Warning on Testosterone Gel Products
Boxed warning and medication guide to highlight the risks of children being inadvertently exposed to testosterone…
Alert on Disetronic ACCU-CHEK Spirit Insulin Pumps
To ensure the “up” and “down” buttons are working, verify the confirmation signal after each pump operation…
New Safety Information on Tarceva
Labeling revised to warn of gastrointestinal perforation, ocular disorders, and certain serious skin conditions…
Update on Precipitate Formation with Ceftriaxone and Calcium-containing Products
Ceftriaxone (Rocephin and generics) and products containing calcium may now be administered within 48 hours of one another to patients over 28 days old, if certain precautions are followed…
Safety Problems with Denture Cleansers
Patients who use denture cleansers may suffer allergic reactions or mis-use these products…
Avoiding Infant Burns from Heel Warmers
First and second degree burns have been reported…
Avoiding Errors with Lamictal Starter Kits
To prevent over or underdosing, pharmacists should make sure the correct Lamictal starter kit has been prescribed to treat patients with epilepsy or bipolar disorder…
Warning on Accidental Ingestion of Benadryl Topical Gel
Packaging and labeling may contribute to patient mix-ups…

Posted 7/6/2009

MedWatch – Lantus (insulin glargine): FDA reviewing safety data re: possible risk for cancer in patient with diabetes
Lantus (insulin glargine) – Audience – Diabetes healthcare professionals, patients
FDA notified healthcare professionals and patients that it is aware of four recently-published observational studies that looked at the use of Lantus (insulin glargine) and possible risk for cancer in patients with diabetes. Three of the four studies suggest an increased risk for cancer associated with use of Lantus. Based on the currently available data, the FDA recommends that patients should not stop taking their insulin therapy without consulting a physician, since uncontrolled blood sugar levels can have both immediate and long-term serious adverse effects.
FDA is currently reviewing many sources of safety data for Lantus, including these newly published observational studies, data from all completed controlled clinical trials, and information about ongoing controlled clinical trials, to better understand the risk, if any, for cancer associated with use of Lantus. Discussions are also ongoing between FDA and the manufacturer of Lantus as to whether any additional studies evaluating the safety and efficacy of this drug will need to be performed. FDA will communicate the results on its ongoing review to the public, as appropriate, as our review continues.
The FDA encourages both healthcare professionals and patients to report side effects from the use of insulin glargine to the FDA’s MedWatch Adverse Event Reporting Program at www.fda.gov/medwatch/report.htm.
Read the complete MedWatch Safety summary, including a link to the Early Communication and supporting documents, at:http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm170089.htm
Posted 07/1/2009

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