FDA Approves Kcentra to Reverse Anticoagulation
TUESDAY, April 30 (HealthDay News) -- Kcentra (prothrombin complex concentrate, human) has been approved by the U.S. Food and Drug Administration to treat severe acute bleeding in adults after administration of warfarin and similar products.
Blood plasma is the only other product approved for this use, the FDA said in a news release, but plasma requires blood typing and may require thawing. This means Kcentra usually can be administered more quickly than plasma to stop major bleeding.
Kcentra will carry a boxed label warning that it may increase users' risk of blood clots. Made from the pooled plasma of screened donors, it's processed to minimize risk of viral and other disease transmission, the agency said.
In a study of 216 people who had been receiving anticoagulation therapy and who developed major bleeding, Kcentra was found to be as effective as plasma in treating the problem, the FDA said.
The drug is produced by the German company CSL Behring.
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