FDA approves drug for urgent warfarin reversal
FDA Approves Kcentra to Reverse Anticoagulation
HealthDay News -- The FDA has approved the first non-activated 4-factor prothrombin complex concentrate (Kcentra) to treat severe acute bleeding in adults after administration of warfarin or other vitamin-K antagonists (VKAs).
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 is administered in a significantly lower volume than plasma at recommended doses, providing an alternative for those patients who may not tolerate the volume of plasma required to reverse VKA anticoagulation,” Karen Midthun, MD, director of the FDA's Center for Biologics Evaluation and Research, said in a press release.
Approximately four million people in the United States take anticoagulants to prevent blood clots from forming following a stroke, myocardial infarction, heart valve surgery, deep vein thrombosis/pulmonary embolism or certain types of irregular heartbeat, such as 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.
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.
The 4-factor prothrombin-complex concentrate contains vitamin K-dependent coagulation Factors II, VII, IX, and X, along with Protein C and Protein S. As with plasma, the injection is administered together with vitamin K.
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.