Pradaxa (dabigatran) is a popular blood thinner, but has been associated with serious risks of internal bleeding, and for a long time did not have a significant Pradaxa reversal agent.

The lack of a Pradaxa reversal agent meant that patients using Pradaxa were placed at risk of internal bleeding complications without a way to slow down that bleeding in the case of an emergency.

While all anticoagulants carry with them an added risk of internal bleeding problems, Pradaxa and similar drugs lacking reversal agents or antidotes offered no way to counteract bleeding complications in emergency situations.

A body experiencing internal bleeding usually counteracts this naturally by forming blood clots to stem the bleeding, allowing time for emergency medical services to act.

Pradaxa Maker Announces Reversal Agent

Boehringer Ingelheim Pharmaceuticals, the manufacturer of Pradaxa, was allegedly aware of these internal bleeding risks and the importance of an antidote, and has been developing a reversal agent for some time.

In fact, the company recently announced they have developed a Pradaxa reversal agent that they’re calling Praxbind, meant to stop bleeding complications during internal bleeding emergencies.

Boehringer Ingelheim Pharmaceuticals has developed and tested Praxbind over six years, and it was recently approved by the FDA under an accelerated removal approval program due to necessity.

According to the FDA, 1,400 Pradaxa-related adverse events were reported in the years prior to Praxbind’s approval, as well as 280 reported deaths.

The FDA’s accelerated approval means that, while the antidote is available for use, the company is still required to report to the FDA ongoing data about the safety and efficacy of Praxbind as it becomes available.

Boehringer is already emphasizing the existence of Praxbind in its Pradaxa marketing efforts, assuring the public that their drug is now as safe as the traditional blood thinner drugs that already had antidotes.

The major trial for Praxbind is known as RE-VERSE AD, which looked at patients from 35 individual countries. The trial evaluated the effectiveness of Praxbind on Pradaxa patients during emergency internal bleeding situations.

The trial looked at a variety of emergencies, including car accidents, intracranial hemorrhage, and emergency surgeries.

The study was, by necessity, rather small-scale, as it could only track Pradaxa patients involved in major bleeding emergencies that occurred naturally. 123 patients were studied in the RE-VERSE AD trial. 66 patients experienced uncontrollable bleeding, and 57 required emergency surgery.

For patients treated with Praxbind, there was significant evidence of successful reversal of Pradaxa’s blood thinning effects.

26 of the patients involved in the trial died. This number initially seems alarming, but it should be remembered that patients involved in the study were all in life-threatening situations in the first place, and their deaths should be attributed to the emergency itself, such as a serious car accident, rather than the use of Praxbind.

Pradaxa Lawsuits

Before the recent approval of Praxbind, many Pradaxa users experienced major bleeding complications with no available Pradaxa reversal agent.

Some of these patients have responded by filing Pradaxa lawsuits against Boehringer Ingelheim Pharmaceuticals, alleging that the company failed to adequately warn consumers and the medical community about the lack of reversal agent for the serious internal bleeding side effects linked with their drug.

If you or someone you know has taken Pradaxa and experienced internal bleeding side effects, you may be able to file a Pradaxa lawsuit.