Press Announcements > FDA approves Kcentra for the urgent reversal of anticoagulation in adults with major bleeding

Press Announcements > FDA approves Kcentra for the urgent reversal of anticoagulation in adults with major bleeding

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.

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The U.S. Food and Drug Administration today approved Kcentra (Prothrombin Complex Concentrate, Human) for the urgent reversal of vitamin K antagonist (VKA) anticoagulation in adults with acute major bleeding. Plasma is the only other product approved for this use in the United States.

Patients receiving chronic anticoagulation therapy with warfarin and other VKA anticoagulants to prevent blood clotting in conditions such as atrial fibrillation or the presence of an artificial heart valve sometimes develop acute bleeding. Like plasma, Kcentra is used in conjunction with the administration of vitamin K to reverse the anticoagulation effect and stop the bleeding. Unlike plasma, Kcentra does not require blood group typing or thawing, so it can be administered more quickly than frozen plasma.

For more information, please visit: Kcentra.