How Soon Could Pradaxa Have an Antidote?

Washington, DCOne of the biggest concerns about Pradaxa side effects, and the side effects of other new generation anticoagulants, is that there is no approved antidote for certain adverse events. Pradaxa lawsuits have alleged that the maker of the drug did not warn patients about the lack of an antidote, putting them at risk of Pradaxa bleeding events. Now comes word that a Pradaxa antidote could be along in the near future.

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.

Idarucizumab’s safety and effectiveness have not been established. Early data shows no “clinically relevant adverse reactions” to idarucizumab. Boehringer Ingelheim says it is conducting a study in patients in more than 35 countries since May 2014. The antidote could help Pradaxa’s sales, which have been stagnant according to Reuters (4/22/15). Pradaxa has recently faced pressure from similar drugs, Xarelto and Eliquis, but Pradaxa’s antidote would likely be the first available, giving it an advantage over the other anticoagulants.

“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.