FDA OKs drug to reverse warfarin’s anticoagulation effect

The FDA has approved Kcentra, a product made from pooled plasma, for the urgent reversal of anticoagulation in adults with acute major bleeding who received a vitamin K antagonist.

Kcentra in conjunction with vitamin K reverses the anticoagulation effect of warfarin or other vitamin K antagonists that are given to patients with atrial fibrillation, who are recipients of an artificial heart valve or have other conditions that require vitamin K antagonists to prevent blood clotting. In cases of acute bleeding, Kcentra administered with vitamin K stops the 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 [vitamin K antagonist] anticoagulation,” said Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research, in a release.

Plasma is the only other product approved for this use in the U.S. Unlike plasma, Kcentra does not require blood group typing or thawing. It is produced from pooled plasma of healthy donors and is processed in a way to minimize the risk of transmitting viral and other diseases, according to the FDA.

In a study that enrolled 216 patients, Kcentra was found to be similar to plasma in its ability to stop acute major bleeding. Adverse events in trials and postmarketing surveillance included fatal and nonfatal arterial and venous thromboembolic complications. A boxed warning details its risk of blood clots and instructs physicians to monitor patients who received Kcentra for signs and symptoms of thromboembolic events.  

Kcentra is manufactured by King of Prussia, Penn.-based CSL Behring.