Pradaxa (Dabigatran) is one of the most popularly prescribed anticoagulants in the United States, but has been repeatedly associated with serious gastrointestinal bleeding.

This drug was ground breaking in one sense, as it was the first drug to be approved for blood thinning treatment purposes since Warfarin’s approval in the 1960s.

Pradaxa’s initial success then inspired other manufacturing companies to release their own anticoagulants into the market, Xarelto and Eliquis, which became substantial competitors against Pradaxa.

However these new generation anticoagulants have been repeatedly associated with serious gastrointestinal bleeding, and other potentially fatal internal bleeding injuries. Compared to Warfarin, none of the new generation anticoagulants have a widely available bleeding antidote in the case of internal bleeding.

While Praxbind, Pradaxa’s reversal agent, was recently approved, it is currently only available in hospitals to reverse internal bleeding.

Pradaxa is mostly prescribed to patients with atrial fibrillation and who are at high risk for stroke, or to patients who are at risk for blood clot attacks.

Overview of Pradaxa Bleeding Risk

Anticoagulants work by inhibiting the body’s clotting ability, by blocking the body’s direct thrombin inhibitors. This enzyme specifically stops the body from clotting, which does prevent clotting in the blood, but also prevents the body from healing itself in the case of internal bleeding.

In consequence, Pradaxa patients who suffer internal bleeding events require emergency intervention. Furthermore, research has suggested that serious gastrointestinal bleeding was a major risk to Pradaxa patients. According to recent research findings:

• 16.6% may experience Pradaxa internal bleeding
• 3.3% may experience Pradaxa serious bleeding
• 1.5% may experience Pradaxa life threatening bleeding effects
• 0.3% may experience Pradaxa brain hemorrhage

Researchers have also warned that elderly patients with kidney problems may be the most at risk, due to the kidneys being unable to process the drug and causing unusually high levels of circulation. In December 2011, the FDA released a public warning regarding serious gastrointestinal bleeding and other internal bleeding occurrences.

According to the Institute for Safe Medication Practices, over 307 Pradaxa injury reports were submitted within the first three months of the drug’s release in 2012. Even though serious gastrointestinal bleeding can be potentially fatal, Boehringer Ingelheim opted not to include this information on Pradaxa’s warning label.

There has already been a massive Pradaxa settlement in which Boehringer Ingelheim resolved numerous Pradaxa lawsuits.

Pradaxa patients who suffered serious gastrointestinal bleeding or other internal bleeding events may be eligible for legal action. Potential claimants should contact a specialized lawyer, to determine if they have a Pradaxa lawsuit.