Coumadin Recalled Because Adverse Reactions Could Occur Due to Potency Error

May 4, 2011

Bristol-Myers Squibb has announced a recall of its anticoagulant Coumadin® (warfarin sodium) tablets because the potency of the tablets could be incorrect.

Physicians prescribe Coumadin (warfarin sodium) for the prevention of blood clots in the blood and blood vessels. People with an irregular heartbeat, prosthetic heart valve or those who had a heart attack may be taking this medicine. Physicians also prescribe Coumadin for the treatment and prevention of venous thrombosis or pulmonary embolism.

Affected by this recall are 5mg Coumadin tablets. Bristol-Myers Squibb distributes this medication to pharmacies in bottles containing 1000 tablets. The pharmacist then dispenses the tablets to the consumer in quantities ordered by the prescription. The lot number of pills under recall is 9H49374A with an expiry date of September 30, 2012.

“Coumadin is prescribed to treat or prevent blood clots. A decrease of active ingredient may increase the risk of clots which could lead to heart attack or stroke and if there is too much active ingredient, there is an increased risk of bleeding,” says the U.S. Food and Drug Administration (FDA).

Bristol-Myers Squibb initiated the recall after testing tablets from a bottle of Coumadin returned to the company showed one tablet at a higher potency than expected.

Patients can identify the pills by this photo showing a pink tablet with the word “COUMADIN” and number “5” embossed on the surface.

The Los Angeles Times reports that this recall affects 1.8 million Coumadin tablets, but that a company spokesperson told the news source that the company distributed one third of those to Ecuador and Argentina.

“Patients who may have 5 mg tablets should not interrupt their therapy but should seek advice from their pharmacist to see if they have tablets originating from the affected lot and if so, should consult their physician for appropriate medical advice,” Bristol-Myers Squibb said in a release.

Consumers and physicians should report any adverse reactions to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov.