Pradaxa (dabigatran) is a prescription medication used as a blood thinner (anticoagulant) for individuals who have atrial fibrillation, a condition that may lead to stroke. It is also a treatment for venous thromboembolism (VTE).

Pradaxa belongs to a new generation of anticoagulant pharmaceuticals, and is among the first alternatives to the classic blood thinning drug warfarin. It was approved for use in 2010 and is manufactured by Boehringer Ingelheim Pharmaceuticals.

Physicians were pleased to have an alternative to warfarin, as the older drug required more frequent physician visits, diet restrictions and blood tests to monitor treatment response. Pradaxa offered more convenient dosing, less office visits, and the promise of fewer side effects.

However, it didn’t take long for Pradaxa to become mired in controversy. Within two years of its release, Pradaxa was blamed for over 500 deaths. Many families took legal action against Boehringer Ingelheim Pharmaceuticals by filing Pradaxa lawsuits for personal injury and product liability.

Pradaxa Internal Bleeding Complications

The most frequently reported severe side effect linked to Pradaxa use is an increased bleeding risk. Warfarin (under brand names Coumadin and Jantoven) was no stranger to internal bleeding or brain hemorrhages, as those were side effects of the first generation drug as well. What has made it so dangerous, however, is the lack of a Pradaxa antidote.

When patients experienced bleeding complications with warfarin, they were given intravenous vitamin K and fresh frozen plasma or other agents such as Activated Prothrombin Complex Concentrate or Recombinant Factor VIIa. Pradaxa has no antidote to rein in out-of-control bleeding, and such complications have proven to be serious or even fatal.

Additional Pradaxa Side Effects

Many individuals who take Pradaxa have little to no side effects, which may lead consumers into believing the drug is safe. Minor side effects include bruising, bleeding from minor cuts, indigestion, abdominal pain, nausea and heartburn.

Many Pradaxa users who experience severe bleeding complications often start off having little to no trouble with the drug, only to have the severe complications appear suddenly. Other serious Pradaxa side effects include heart attack, liver failure and death.

Pradaxa Lawsuits

From 2010 through 2014, there were thousands of product liability claims filed by consumers and their families in Pradaxa lawsuits against the manufacturer. In May 2014, Boehringer Ingelheim Pharmaceuticals addressed all outstanding claims and lawsuits in a comprehensive settlement of over $650 million.

Despite the settlements in the Pradaxa lawsuits, Boehringer Ingelheim maintained that its product was safe and showed great efficacy in treating the serious conditions for which it is prescribed.

Despite their claims, consumers and their families who have experienced the life-altering side effects of the drug continue to question its safety and continue to pursue legal action against the manufacturer.

If you would like to find out more information about qualifying for a potential Pradaxa lawsuit or Pradaxa class action lawsuit, contact a Pradaxa attorney for a no-obligation consultation to discuss your situation.