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Friday, May 3, 2013

FDA approves treatment for anticoagulation reversal.

The Los Angeles Times (4/30, Healy, 692K) "Science Now" blog reports that the Food and Drug Administration approved Kcentra (prothrombin complex concentrate, human), which was developed to "reverse the effects of warfarin" quickly. Kcentra, which is "made from the pooled plasma of healthy donors," joins a "cluster of other 'reversal agents' capable of restoring coagulation, including vitamin K and fresh-frozen plasma, in people who take warfarin," but it does not "reverse the effects" of two new anticoagulants - Pradaxa (dabigatran) and Xarelto (rivaroxaban). Meanwhile, with the number of Americans with "atrial fibrillation...expected to grow to 5.6 million by 2050," the FDA is "eager to consider therapies that can reverse the anticoagulant effects of these new drugs, as well as products such as Kcentra, which can speed coagulation in those taking warfarin."

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