Pradaxa (Dabigatran) was the first anticoagulant in the United States to be approved for blood thinning purposes since Warfarin in the 1960s.

However, it was not long after its approval that patients started reporting serious incidents of uncontrollable internal bleeding.

Pradaxa is normally prescribed to patients who are suffering from atrial fibrillation, and are at high risk for stroke. This medication would ideally allow the patient to live a longer life, with the reduced risk of suffering a blood clot injury.

Approved by the FDA in 2010 and manufactured by Boehringer Ingelheim, Pradaxa quickly overtook the anticoagulant market and became a pivotal point for other pharmaceutical companies to try their own hands in the world of blood thinners.

Pradaxa, however, was also the start of a dangerous trend of highly efficient new generation anticoagulants without bleeding antidotes. Until recently, with the release of Praxbind, there was no Pradaxa reversal agent available for patients who faced the potential risk of internal bleeding.

This has been a major point of criticism for Pradaxa and newer anticoagulants, and a major selling point of Warfarin in which vitamin K is the bleeding antidote. For Pradaxa, not only is internal bleeding a major problem but it is also the leading cause of death in patients.

Overview of Pradaxa Bleeding Complications

According to the FDA, Pradaxa has been linked to 542 patient fatalities with the Safe Medication Practices stating that the drug was linked to more deaths and injuries in 2011 than any of the other 800 drugs investigated.

Experts explain that by inhibiting the body’s enzyme, thrombin, Pradaxa and other anticoagulants reduce the body’s ability to clot blood but also inhibits the body from stopping bleeding in case of rupture or injury. So even though the drug’s mechanism is helpful in preventing clotting, it can be fatal in the cases of an internal bleed.

For years, the FDA and medical experts were concerned over the risk of internal bleeding injuries. However, Boehringer Ingelheim finally developed a Pradaxa reversal agent in 2015. The FDA granted accelerated approval to Praxbind (Idarucizumab), for patients who suffered internal bleeding injuries while taking Pradaxa.

The FDA granted its approval when positive results were seen in 283 healthy Pradaxa patients by reversing the bleeding immediately in patients. In another ongoing trial, Praxbind was shown to fully reverse the bleeding effects in 89 percent of 123 patients.

Even though there is now a Pradaxa reversal agent, it came too late for the many patients who suffered uncontrollable internal bleeding injures. Case in point, in late May 2014, Boeheringer Ingelheim announced it would pay $650 million settle 4,000 state and federal Pradaxa lawsuits.

Each of these claimants alleged that they had suffered serious injuries due to the bleeding effects of Pradaxa, and were not properly warned against them. Pradaxa patients who suffered internal bleeding injuries may be eligible to file a lawsuit against Boehringer Ingelheim. Potential claimants should contact specialized attorneys to determine if they are eligible to file legal action.