Zydus Pharmaceuticals is recalling some of its generic warfarin blood thinner pills because they may be the wrong size, which could cause patients to suffer excessive bleeding and other potentially life-threatening health problems.
The generic warfarin recall was announced by the FDA on June 10, after Zydus received a complaint about pills from one lot, which turned out to be oversized.
Oversized warfarin pills could cause users to face increased blood thinning effects that put them at danger of severe bleeding problems. Although there have been no reports of adverse bleeding events linked to the recalled warfarin pills, the manufacturer is urging patients to make sure that all tablets are the same size.
The pills affected by the recall include warfarin 2 mg tablets with a lot number of MM5767 and an expiration date of June 2014. They have an NDC number of #6838205310 and were distributed in the United States from November 2012 to December 2012.
Warfarin has been sold for decades in the United States, most commonly known by the brand name Coumadin. The anticoagulant medication is used for prevention of thromboembolic complications, such as pulmonary embolism, and problems with atrial fibrillation and the prevention of strokes. It dominated the market until 2010, when a new generation of blood thinners like Pradaxa and Xarelto began to hit the market.
While this new class of medications has grown in popularity because they are easier to take, requiring less frequent monitoring during treatment to maintain therapeutic levels, concerns about arose about the potential risk of severe bleeding problems with Pradaxa. Unlike the anticoagulant effects of warfarin, which doctors can easily reverse with a dose of vitamin K, there is no reversal agent available for Pradaxa and Xarelto, which have resulted in many reports of uncontrollable bleeding that doctors were helpless to stop.
A growing number of Pradaxa lawsuits have been filed against Boehringer Ingelheim, alleging that the drug maker failed to adequately warn doctors and patients about the risks of Pradaxa bleeding.