Pradaxa (Dabigatran) was approved by the Food and Drug Administration (FDA) in 2010 to be a treatment method for patients with atrial fibrillation and to prevent stroke.

However, since it was introduced to the market, a number of adverse events involving Pradaxa bleeding injuries have been reported.

Manufactured by German drug maker Boehringer Ingelheim Pharmaceuticals, Pradaxa was the first blood thinner to be released in the United States since Warfarin in the 1950s. Its release inspired American pharmaceutical companies to break into the anticoagulant market with the release of Xarelto and Eliquis.

While each of the new generation anticoagulants were advertised to work faster and be more convenient to take than warfarin, the drugs lacked a vital safety feature. In contrast to Warfarin, there was no way to remedy Pradaxa bleeding incidents. Eliquis and Xarelto sharing the same problem.

Pradaxa Bleeding Antidote

The purpose of blood thinners is to prevent blood clotting, which is what Pradaxa does. However, the several bleeding injuries reportedly caused by Pradaxa became a problem. Boehringer Ingelheim Pharmaceuticals took corrective measures by developing a bleeding antidote to Pradaxa complications.

FDA officials have called this development necessary, as it will prevent potentially fatal bleeding injuries. The federal agency approved the Pradaxa antidote, Praxbind (Idarucizumab) and accelerated its availability in the market.

In a June 2015 editorial from The New England Journal of Medicine, Professor Kenneth A. Bauer of Harvard Medical School stated that the bleeding remedy completely neutralized the effects of Pradaxa.

However, the release of the Pradaxa antidote may have come too late for many patients who experienced serious Pradaxa complications including internal hemorrhaging and even death.

Overview of Pradaxa Bleeding Complications

Pradaxa is a direct thrombin inhibitor drug, which works by inhibiting certain enzyme that clots blood. Unfortunately this treatment mechanism has caused numerous internal bleeding incidents, which has led to many hospital visits and deaths.

Research suggests that patients suffer a variety of Pradaxa complications with findings indicating:

• 6% of patients experience some form of Pradaxa bleeding
• 3% of patients experiences serious Pradaxa bleeding
• 5% of patients may experience fatal Pradaxa bleeding
• 3% of patents may experience Pradaxa brain hemorrhaging

According to a recent report by the Institute for Safe Medication Practices (ISMP), over 307 Pradaxa complications were reported to the FDA during the first three months the drug was on the market. This statistic surpasses 98.7% of other medications monitored by the ISMP and is 50% greater in number compared to Warfarin reports.

Additionally, the FDA released a public safety warning regarding Pradaxa complications in December 2011 to the medical community and patient population. The warning came after numerous Pradaxa bleeding injury reports were submitted, spurring the agency to conduct a post-marketing study.

Even though the FDA stated that uncontrollable bleeding was a well-known risk associated with anticoagulants, the agency was investigating to determine if Pradaxa was unreasonably dangerous.

While the Pradaxa bleeding antidote is helpful, it has come too late to many former patients. Pradaxa bleeding injuries have resulted in many Pradaxa lawsuits, and has led Boehringer Ingelheim Pharmaceuticals to settle Pradaxa bleeding allegations for millions.