Voluntary Coumadin Recall

http://www.fda.gov/Safety/Recalls/ucm253523.htm  :
Bristol-Myers Squibb Initiates a Nationwide Voluntary Recall of Coumadin® (Warfarin Sodium) Crystalline 5 mg Tablets, Lot Number 9H49374A

When  I clinically practiced as an hematologist, I dealt with a variety of anticoagulants, both as an initiator of treatment  and as a consultant called when things went wrong.  I have seen anticoagulants, such as warfarin (trade name - "Coumadin") and heparin (and its derivatives) save lives, and I have seen them cause severe bleeding (and other)  complications including death.  In practice,  I constantly kept in mind the 2% case-fatality rate associated with warfarin and the particular risk that was seen in frail elderly women for whom it was prescribed.


The indications for warfarin treatment usually involved the formation of blood clots in the venous system and the risk that a clot would dislodge, travel to the lungs as a pulmonary embolism, and cause death or severe lung damage. At Stanford, I trained with hematologist Professor Edward Hershgold, who taught us great respect for warfarin, expounding on accumulated clinical research with this drug, and drilling us on  its ability to induce anticoagulation slowly (over 7-10 days), sometimes when laboratory tests suggested that it had more quickly achieved its intended effect.

In my consultant practice, I saw the dark side of warfarin when physicians who used warfarin infrequently did not carefully and fully educate their patients on the proper use of warfarin, dietary management, the risks of drug interactions with medications commonly prescribed by physicians, and the requirement for frequent laboratory testing of the"prothrombin time" and "INR" in following the appropriateness of the anticoagulation level achieved.  In our health law practice, we saw physicians charged with being inconsistent in testing their patients for anticoagulation and then properly communicating with their patients about the results of their tests and prescribing instructions, sometimes with serious adverse consequences which endangered their medical licenses.

With all of those considerations in mind, I  highlight a voluntary Coumadin recall of one lot of Coumadin by its manufacturer Bristol-Myers Squibb as as a precautionary measure based on the company’s testing of tablets from a returned bottle. A single tablet was found to be higher in potency than expected.

If any of my readers take Coumadin or have friends or family taking Coumadin, I suggest that they refer to the link to the FDA release and follow the recommendations in that FDA release.  For those who require anticoagulation, the dose (generic or brand name) must be just right, not too high or too low.











FOR IMMEDIATE RELEASE - May 2, 2011 - Bristol-Myers Squibb initiated a voluntary recall of one lot of 1,000-count bottles of Coumadin® (warfarin sodium) Crystalline 5 mg tablets. Bottles of 1,000 tablets are distributed to pharmacies for further dispensing to patients in prescription quantities. The lot number affected in the U.S. is 9H49374A with an expiry date of September 30, 2012. The recall is a precautionary measure based on the company’s testing of tablets from a returned bottle. A single tablet was found to be higher in potency than expected.

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.

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 is committed to ensuring patient safety and is working to resolve this issue quickly and appropriately. The company has notified the U.S. Food and Drug Administration (FDA), and will issue recall communications to all physicians and other customers involved.

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.

Health care professionals and customers may call the following for assistance if they have further questions about the recall:

 For information related to this recall:
 Stericycle, Inc.
 1-866-918-8739