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FDA OKs Kcentra for Fast Fix of Coumadin Bleeds- 5/4/2013 12:00:00 AM

FDA OKs Kcentra for Fast Fix of Coumadin Bleeds By Chris Kaiser, Cardiology Editor, MedPage Today Published: April 30, 2013 By Chris Kaiser, Cardiology Editor, MedPage Today Published: April 30, 2013 The FDA has approved Kcentra for the urgent reversal of vitamin K antagonist anticoagulation in adults with acute major bleeding, according to the agency. Kcentra, a prothrombin complex concentrate (PCC) made from the pooled plasma of healthy donors, is only the second product to be approved for this use in the U.S. Unlike plasma, the first such approved product, Kcentra does not require blood group typing or thawing, so it can be administered more quickly than frozen plasma. In addition, the volume of Kcentra administered is significantly lower than plasma at recommended doses, providing an alternative for those patients who may not tolerate the volume of plasma required to reverse vitamin K antagonist anticoagulation, the FDA noted in a press release. About 4 million patients in the U.S. take warfarin to prevent blood clots from forming following a stroke, heart attack, heart valve surgery, deep vein thrombosis/pulmonary embolism, or atrial fibrillation. If any of these patients are wounded or need emergency surgery, the anti-clotting effects of the drug must be reversed as quickly as possible to prevent major bleeding. The new drug is referred to as a four-factor concentrate because it contains factors II, VII, IX, and X -- all of which are low in patients treated with warfarin or other vitamin K antagonists. Stephen Moll, MD, on his Clot Connect blog, said he welcomes the new four-factor concentrate over the three-factor PCCs -- which are sometimes used off-label for this indication -- and fresh frozen plasma. "Where until now I used to give three-factor PCCs, I will from now on give the four-factor PCC," he wrote. He speculated whether Kcentra would also be a suitable reversal agent for the new oral anticoagulants such as rivaroxaban, dabigatran, and apixaban, which do not have specific reversal antidotes. "As some hospitals and clinicians presently have three-factor PCCs on their reversal algorithm, it is fair to consider a review and possible modification of the hospital treatment guidelines on the management of major bleeding not only on warfarin, but also on the new oral anticoagulants," Moll wrote. The FDA approval of Kcentra is based on a study of 216 patients who had been receiving vitamin K antagonist anticoagulation and who had acute major bleeding along with a clotting test value indicative of anticoagulant use. Kcentra was demonstrated to be similar to plasma in terms of the ability to stop acute major bleeding. The most common adverse reactions observed in the study were headache, nausea/vomiting, arthralgia, and hypotension. The most serious adverse reactions were thromboembolic events including stroke, pulmonary embolism, and deep vein thrombosis. A boxed warning for Kcentra alerts users to the risk of blood clots associated with the drug, which is made by CSL Behring. From the American Heart Association: Oral Antithrombotic Agents for the Prevention of Stroke in Nonvalvular Atrial Fibrillation

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