FDA to consider warfarin reversal agent for bleeding emergencies
The Food and Drug Administration (FDA) has agreed to review a human 4-factor prothrombin complex concentrate (PCC) for the urgent reversal of vitamin K-antagonist therapy (warfarin) in patients with acute major bleeding. If approved, it would be the first agent of its kind available in the United States.
PCC aims to address the unmet need for a rapid and simple way to reverse the effects of warfarin during bleeding emergencies. “This 4-factor PCC has the potential to be a significant tool in stopping excessive bleeding in patients on warfarin, where fresh frozen plasma is the current standard of care,” says Val Romberg, Senior Vice President of Research and Development at CSL Behring, the company that developed the drug.
Warfarin is a blood thinner that is used to prevent or treat blood clots in the legs, in the lungs, or in patients with a type of irregular heart rhythm known as atrial fibrillation. If left untreated, blood clots can lead to stroke.
Warfarin was the only blood thinner used to treat patients with atrial fibrillation until 2010, when the FDA approved the anticoagulant Pradaxa. Both warfarin and Pradaxa carry a risk for internal bleeding. There are treatments available to reverse the anti-clotting effects of warfarin. PCC offers an easier option.
However, there are currently no antidotes for Pradaxa, and the FDA has already seen hundreds of reports of bleeding events, some of them fatal, associated with the drug. The FDA is currently investigating the safety of Pradaxa and the dire need for an antidote.
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