Anticoagulants lower the occurrence of blood clots, preventing strokes from occurring. Because they thin the blood, however, they also prevent blood from clotting under normal circumstances, increasing the risk of an uncontrolled bleeding event. Warfarin, an older anticoagulant, had an antidote in the form of vitamin K, which could be used to reverse the anticoagulant effects and stop bleeding events.
Newer generation anticoagulants do not have a widely accepted antidote, which means when a bleeding event occurs, the patient is at risk of uncontrolled bleeding causing serious injury or even death. Lawsuits have been filed concerning Pradaxa and Xarelto, with approximately 4,000 Pradaxa claims settled by Boehringer Ingelheim for $650 million in May 2014.
According to a press release from Boehringer Ingelheim, an antidote to Pradaxa is on the horizon. The drug, called idarucizumab, is reportedly on the FDA’s fast track for accelerated approval and would make Pradaxa the first newer-generation anticoagulant to have a reversal agent.
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“If approved, idarucizumab has the potential to be a significant evolution in care by providing physicians with an option for PRADAXA patients in rare emergency situations that may require rapid reversal of the anticoagulation effect of dabitagran,” said Sabine Luik, MD, senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Phramaceuticals, Inc.
Despite the settlement in 2014, there are still more than 1,600 Pradaxa lawsuits consolidated before US District Judge David Herndon under MDL 2385 in the Southern District of Illinois as of April 15, 2015.