The blood thinner Pradaxa (dabigatran) has become increasingly popular in recent years as a replacement for the traditional staple anticoagulant, warfarin, but it has carried with it one major issue – unlike warfarin, there was no Pradaxa antidote to control any potential bleeding complications.

However, Pradaxa manufacturer Boehringer Ingelheim Pharmaceuticals has been working to develop a Pradaxa antidote to eliminate this problem. Boehringer came up with a Pradaxa reversal agent called Praxbind, which has even been effective in stopping bleeding complications during real-world emergencies.

Praxbind was approved in October 2015, after around six full years of development and testing. While the Pradaxa antidote was approved, the FDA did this under an accelerated approval program. This means that Boehringer Ingelheim Pharmaceuticals is still required to report its data about the safety and efficacy of Praxbind moving forward.

While most patients who take Pradaxa do not experience life-threatening side effects like serious bleeding complications, in the event that these occur, a Pradaxa antidote is necessary to prevent a patient from losing too much blood.

A patient may need to use a Pradaxa antidote in one of two situations: either because they must undergo an urgent surgery or because of life-threatening bleeding complications.

During the years Praxbind was in development, 1,400 Pradaxa-related adverse events were reported, as well as 280 reported deaths.

Pradaxa Antidote Study

The Praxbind trial was called RE-VERSE AD, and studied patients from 35 separate countries. The trial was intended to evaluate the effectiveness of Praxbind when Pradaxa patients suffered emergency situations, from car accidents to intracranial hemorrhage to emergency surgery.

123 patients were involved in the RE-VERSE AD analysis. 66 of these patients suffered from uncontrollable bleeding complications, and 57 required emergency surgery. When Praxbind was used to treat patients, successful reversal was obvious.

While Praxbind clearly acted as an effective Pradaxa reversal agent, there were some side effects involved. Five of the study’s patients dealt with thrombotic events, which occur when a blood clot obstructs a blood vessel, but these patients were not receiving antithrombotic therapy, so this is not a major concern.

There were also 26 deaths of patients involved in the study, which may seem like an alarming number. However, it should be noticed that for a patient to be involved in the study in the first place, they must first be in a life-threatening bleeding situation. Each of these deaths appears to be related to the emergency situation itself (such as a car accident or emergency surgery) rather than the use of Praxbind.

According to Dr. Charles Pollack, the lead trial investigator, “The data from this new RE-VERSE AD interim analysis, of the first 123 patients, support earlier findings that show idarucizumab reverses the anticoagulant effect of dabigatran, including reversal in critically ill, high-risk patients in emergency care.”

Pradaxa Lawsuits

Before Praxbind was approved, Pradaxa users went a long time with no Pradaxa antidote to use in emergency bleeding situations. Many have chosen to file Pradaxa lawsuits.  These Pradaxa lawsuits allege that Boehringer Ingelheim Pharmaceuticals failed to give adequate warning about the bleeding side effects and the lack of a reversal agent.

If you or someone you know has taken Pradaxa and has subsequently experienced bleeding complications due to Pradaxa, you may have cause for filing a Pradaxa internal bleeding lawsuit.