Amidst intense litigation regarding allegations of uncontrollable bleeding, the pharmaceutical manufacturer Boehringer Ingelheim has announced an antidote for their popular anticoagulant Pradaxa.

Pradaxa has been at the center of serious bleeding allegations for the past several years, but a new study published in the online version of the New England Journal of Medicine on June 22, 2015, found that the antidote, idarucizumab, works to stop bleeding within minutes.

The study, funded by Boehringer Ingelheim and led by Dr. Charles Pollack Jr. of Thomas Jefferson University in Philadelphia, observed 90 subjects who suffered uncontrollable bleeding after needing emergency surgery or experiencing acute trauma while taking Pradaxa. The patients were treated with idarucizumab, which successfully reversed all of the internal bleeding incidents. After receiving the Pradaxa antidote, over 90 percent of the patients’ blood-clotting levels went back to normal.

The study’s authors are optimistic that the FDA will approve the bleeding antidote soon, and that the antidote will ultimately save the life of many Pradaxa patients who experience an internal bleeding event. The researchers believe that with the availability of a Pradaxa antidote, doctors will be less reluctant to prescribe the anticoagulant. Other experts who reviewed the study agree with this assessment.

Overview of Pradaxa Bleeding Allegations

For years, Warfarin was the only option for patients who needed an anticoagulant prescription. While Warfarin required regular dose adjustments and medical monitoring, it had the benefit of an antidote to stop bleeding events. Pradaxa was meant to replace Warfarin, and was advertised as faster-acting and more convenient. The anticoagulant comes in one convenient dose, eliminating the need for frequent doctor’s appointments and dose adjustments. Unfortunately, until now Pradaxa’s lack of an antidote has led to severe bleeding injuries.

These bleeding injuries have given rise to numerous lawsuits against Pradaxa’s manufacturers, with the plaintiffs claiming that the company failed to protect them against the risks of their product. The Pradaxa plaintiffs allege that Boehringer Ingelheim deliberately omitted the risk of uncontrollable internal bleeding from Pradaxa’s warning label in order to protect the drug’s market share. Now with the development of idarucizumab, Boehringer Ingelheim has a shot at climbing back into grace.