FDA approves new drug to reverse effects of warfarin

The FDA recently approved a new drug for the reversal of vitamin K anticoagulation in adults with acute major bleeding. The drug is Prothrombin Complex Concentrate (KCENTRA), and contains the vitamin K dependent clotting Factors II, VII, IX, and X, as well as antithrombotic Proteins C and S. The only other product approved for this use in the United States is plasma. A caution with the use of this product is that it is associated with blood clots when used as indicated. The product comes with a Boxed Warning on this subject.


  1. FDA approval of KCENTRA
  2. Kcentra product page