Pradaxa (dagibatran) is a blood thinner prescribed to prevent strokes in patients who suffer from atrial fibrillation and venous thromboembolism (VTE).

While Pradaxa has been considered a groundbreaking advance in the pharmaceutical industry, Pradaxa lawsuits filed against the drug’s manufacturer allege that Pradaxa may cause uncontrollable bleeding.

Atrial fibrillation is a heart condition that causes the heart to beat irregularly and often rapidly, which can lead to an increased risk of stroke due to blood clots forming in the heart and blocking blood flow. VTE is the general formation of blood clots in a vein and can likewise lead to an increased risk of stroke.

Pradaxa helps to treat these two conditions by blocking clotting proteins in the blood so the tendency to clot is reduced or eliminated, thus reducing the risk of further complications from atrial fibrillation or venous thromboembolism.

Pradaxa: A Groundbreaking Alternative

Pharmaceutical company Boehringer Ingelheim introduced Pradaxa in 2010 as a valid alternative to warfarin (Coumadin), the standard anticoagulant medication that was used for 50 years before Pradaxa hit the market.

Physicians and patients alike were pleased with Pradaxa, as it reduced or eliminated the things that made warfarin difficult to administer and manage in patients. While patients taking warfarin required frequent lab and doctor visits to monitor treatment response, Pradaxa required much less frequent monitoring.

Likewise, patients taking Pradaxa were able to eliminate the special diet that Warfarin patients had to follow so that certain nutritional compounds did not interfere with the drug.

When Pradaxa was introduced, the patient and physician response showed that the drug was a welcome alternative to its more cumbersome predecessor. After just a year on the market, 16 percent of patients with atrial fibrillation were taking Pradaxa, and 44 percent were taking warfarin.

More and more physicians began to prescribe the new drug in the years that followed.

The Dark Side of Pradaxa

By late 2012, however, Pradaxa had been named as the cause of more than 500 deaths due to Pradaxa complications of hemorrhaging and uncontrollable internal bleeding. Families began to take action and began to file Pradaxa lawsuits against the manufacturer, Boehringer Ingelheim, alleging the drug caused personal injury.

In May 2014, Boehringer Ingelheim reached a settlement to resolve all pending Pradaxa lawsuits that were part of multidistrict litigations. The company paid over $650 million to more than 4,000 plaintiffs, though the manufacturer did not admit any wrongdoing.

Pradaxa bleeding lawsuits questioning Pradaxa’s safety have centered around the lack of a Pradaxa antidote. When patients were taking warfarin, the clotting mechanism in the blood could be restored by using fresh frozen plasma and vitamin K as a reversal agent.

However, up until very recently, Pradaxa has had no antidote. This has led many patients to experience uncontrolled internal bleeding, and some have had permanent damage or have died from this unfortunate side effect.

With Boehringer Ingelheim’s development of the new Pradaxa antidote, Praxbind, it is hoped that patients will no longer have to suffer from the severe bleeding complications that other Pradaxa users have endured in the past.

However, for those who have already experienced the devastation of Pradaxa side effects, the development was not timely enough to change the course of events that they allege were caused by Pradaxa.