Ever since the release of Pradaxa in 2010, patients have been reporting uncontrollable internal bleeding injuries as an alleged result of the drug.

After several years of severe Pradaxa complications, Boehringer Ingelheim has successfully developed a bleeding antidote to counteract the effect.

On Oct. 16, 2015, the Food and Drug Administration (FDA) approved Praxbind (Idarucizumab) to reverse the effects of Pradaxa in patients who would normally require emergency intervention. Its approval followed after successful results came from pharmacokinetic and pharmacodynamic studies from 283 subjects.

Patients from an ongoing single cohort series of cases were also observed,who had suffered life-threatening Pradaxa bleeding injuries and needed emergency surgery. Researchers found that Praxbind almost immediately reversed the effects of Pradaxa, resulting in successful clotting.

The Pradaxa antidote stayed in effect even after 24hrs of administration, and had gained accelerated approval from the FDA.

Overview of Pradaxa Bleeding Complications

When Pradaxa was released into the United States, it was first blood-thinner to be released into the United States since warfarin in the 1950s.

Soon after it was introduced into the market, Pradaxa outpaced warfarin in popularity and spurred other pharmaceutical companies to break into the anticoagulant market. Pradaxa is prescribed to patients with atrial fibrillation and to patients who are at high risk for stroke for its anti-clotting treatment mechanism.

This drug works by inhibiting an enzyme called thrombin, which causes blood platelets to bind together. For years, warfarin was the only treatment option patients had and were required to adhere to a strict dosing schedule and frequent doctor appointments.

In contrast, Pradaxa and the other new generation anticoagulants are only prescribed in one dose and do not require intense medical monitoring. However, warfarin also had a stopping agent to implement in the case of internal bleeding, Vitamin K, while the new generation blood thinners did not have such a precaution.

According to a recent RE-LY clinical safety study, Pradaxa has caused at least 260 deaths worldwide. The RE-LY trial is a significant safety study comparing warfarin and Pradaxa, and reported the following rates of serious Pradaxa bleeding injuries:

• 16.4% experienced bleeding
• 3.3% experienced serious bleeding
• 1.5% experienced life-threatening bleeding
• 0.3% experienced life-threatening brain bleeding
• 17.4% needed emergency surgery from serious bleeding

Overall, the RE-LY study found that Pradaxa carried a 6% increased risk for serious internal bleeding every year.

While many patients can breathe a sigh of relief, this antidote has come too late to the thousands of patients who already suffered Pradaxa bleeding injuries according to some who had firsthand experience of Pradaxa’s bleeding complications

Many have alleged that Pradaxa and other new anticoagulants failed to adequately describe the full scope of the internal bleeding risks. Numerous Pradaxa lawsuits have been filed against Boehringer Ingelheim alleging the manufacturer failed to protect plaintiffs against the drug’s dangerous side effects.

If you have suffered intestinal bleeding as a result of Pradaxa use, an attorney can review your claim at no cost to help you determine your legal options.