Biopharmaceutical company Bristol-Myers Squibb has issued a voluntary recall of its popular Coumadin medication which is also known under the generic name warfarin. The product is a blood thinner that is prescribed to treat and/or prevent blood clots and avert heart attacks and strokes.
The recall of the drug is being described as precautionary in nature.
Bristol-Myers had initiated the May 2 recall in cooperation with the U.S. Food and Drug Administration. One lot of Coumadin Crystalline 5 mg tablets is being pulled off the market due to the possibility of wrong potencies manufactured into the tablets. The lot number of the drug, which was sold in the U.S., is 9H49374A with an expiration date of September 30, 2012. The drug is distributed to pharmacies in bottles holding quantities of 1,000; pharmacists then break down the numbers for individual prescriptions they fill for their customers.
Bristol-Myers states on their website “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.”
During internal testing, a single tablet was found to have higher degrees of potency than it should have contained and the company wants to ensure that other tablets are also not over or under dosing patients using the drug. An decrease in proper dosage can result in heart attack/stroke, and too much of the active ingredient in the drug can increase the risk of bleeding.
According to TheHeart.org, close to 2.5 million pills are affected in this recall. Pills were distributed primarily in the U.S. market, however Argentina and Ecuador also received about 600,000 tablets in their marketplaces. The Coumadin tablets that came from Lot 9H49374A and distributed in Argentina and Ecuador were packaged into blisters.
Coumadin is one of the top brands for anticoagulants on the market, and the company contacted, and is working with the FDA to identify and fix the problem which led to the wrongful dosage contained in the drug.
Bristol-Myers had recalled three lots of Coumadin in July 2010 for reasons relating to a deficiency in the ability to maintain the active ingredient.
The company has recently reported a 33 percent jump in their profits for the 1st quarter of 2011.
Consumers who have questions or concerns regarding this recall can contact Stericycle, Inc. at 866-918-8739.