On May 2, 2011, the drug Coumadin was recalled by its manufacturer due to concerns about possible high potency. Bristol-Myers Squibb has issued a voluntary nationwide recall of its popular blood thinner that is packaged in 1,000 count bottles. This large drug company ranks in the top 20 pharmaceutical companies for global sales topping 14 billion dollars in 2009.
Affected Coumadin was Distributed to US, Equador and Argentina
Consumers should be informed that the specific lot number of recalled coumadin in the U.S. is 9H49374A with an expiration date on the bottle of September 30, 2012. Bristol-Myers Squibb admits that the recall is a precautionary measure as the company found a single tablet from a returned bottle that had a higher potency than it should have had.
The company reports that the recall affects approximately 2.5 million pills. A Bristol-Myers Squibb spokesperson states that the affected bottles were distributed to Equador and Argentina as well as the U.S.
High Potency of Drug Coumadin can Lead to Bleeding
The recalled drug coumadin (its official name is warfarin sodium) is often prescribed by medical providers for treatment and prevention of blood clots. According to the manufacturer, if the potency of the coumadin is too low, blood clots can form and lead to heart attacks or strokes. If the potency is too high, as it was in this case of affected coumadin, the patient can suffer from too much bleeding or even hemorrhage.
Bristol-Myers Squibb Notifies Patients and FDA of Recall
Bristol-Myers Squibb has taken measures to notify the FDA so that medical care providers can be alerted to the potential problems with coumadin and the reason for the voluntary recall.
The company urges that patients who are currently taking coumadin should not interrupt their treatment, but instead to consult with their pharmacist to confirm whether or not they are taking tablets from the affected lot of medication.
Reporting Reactions to Coumadin
Brisol-Myers Squibb advises that any person who experiences a reaction to the drug should do the following:
Any adverse reactions may be reported 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.
Sources:
- Reuters.com, Factbox: 20 Largest pharmaceutical companies
- Bristol-Myers Squibb Initiates a Nationwide Voluntary Recall of Coumadin (warfarin sodium) Crystalline 5 mg tablets, Lot number 9H49374A, www.bms.com/news releases
- "Coumadin Tablets Recalled on Potency Concerns" Medscape Today, May 3, 2011
Brenda Lane - Brenda Lane is a published author, Lamaze certified childbirth educator, DONA certified birth doula and approved birth doula trainer.
