Pradaxa hemorrhage has been a prevalent concern for patients since its release in 2010, with patients complaining the drug induced potentially fatal internal bleeding injuries.

At this point, Boehringer Ingelheim has faced serious legal action for unexpected Pradaxa hemorrhage The company still facing problems from the ongoing Pradaxa internal bleeding litigation.

The Pradaxa internal bleeding class action lawsuit investigation is currently evaluating product liability claims, from patients alleging they experienced Pradaxa hemorrhage.

Overview of Pradaxa Hemorrhage

At this point in time, Pradaxa has been linked to at least 260 deaths worldwide, with Boehringer Ingelheim stating that Pradaxa’s fatality rate was equivalent to that of warfarin. The company based this statement on results of the RE-LY clinical safety study, which found the following rates of Pradaxa hemorrhage injuries:

• 17.4% of patients experienced a need for emergency intervention
• 16.4% of patients experienced internal bleeding
• 3.3% of patients experienced serious internal bleeding
• 1.5% of patients experienced life threatening bleeding
• 0.3% of patients experienced life threatening cerebral hemorrhage

Overall, the RE-LY researchers found patients faced a 6% risk of major Pradaxa hemorrhage every year.

However, doctors in New Zealand were reportedly concerned over the RE-LY safety study regarding younger patients facing a lesser likelihood of internal bleeding. Doctors found that patients older than 75 and suffering from kidney problems were at highest risk for Pradaxa hemorrhage.

Pradaxa hemorrhage has been reported since it first entered the market, with the Institute of Safe Medication Practices (ISMP) stating “within weeks of approval, the new drug surged to near the top of the adverse event rankings with reports of hemorrhage and bloodclots.”

The ISMP also pointed out that Pradaxa was the most frequently reported drug for injuries during its first year on the market, with 817 injury reports in 2011 alone. According to a 2015 report in QuarterWatch, Pradaxa continued to have the largest number of serious injury reports in the United States, including severe hemorrhages and patient deaths.

In 2014, there were 3,592 Pradaxa injury reports submitted with 75% of them involving Pradaxa hemorrhage.

New Anticoagulants

Pradaxa was the first medication to be approved for anticoagulant treatment purposes since warfarin in the 1950s, and was considered a significant breakthrough. Since its approval, other pharmaceutical companies have released their own new generation anticoagulants to break into the lucrative medication market. Pradaxa and other new generation anticoagulants are marketed heavily for their single daily dose dosing schedule and the lack of a need for ongoing blood monitoring.

This contrasts greatly from warfarin, which requires patients to undergo frequent dose adjustments from their physicians. In addition, warfarin had an easy reversal agent available in the case of internal bleeding injuries. Boehringer Ingelehim eventually developed its own Pradaxa reversal agent in the form of Praxbind in 2015, which is now available for emergency treatment.

However, even with this reversal agent available, patients are continuing to report instances of Pradaxa hemorrhage. The FDA continues to review Pradaxa injury reports, and encourages patients and doctors to be wary against potentially fatal internal bleeding.

Patients who developed unexpected Pradaxa hemorrhage may be able to file legal action against Boehringer Ingelheim. Potential claimants should contact a lawyer to determine eligibility for a Pradaxa hemorrhage lawsuit.