For years after Pradaxa was introduced, patients lived with the risk of Pradaxa uncontrollable bleeding without the benefit of an available antidote.

Pradaxa (dabigatran) is an anti-coagulant drug manufactured by Boehringer Inglehiem Pharmaceuticals. The drug is part of a class known as direct thrombin inhibitors and was approved by the U.S. Food and Drug Administration (FDA) in 2010. Like many blood thinning drugs, Pradaxa was released as a direct competitor to warfarin which has been the most commonly prescribed blood thinner for the past 60 years.

Warfarin has stood the test of time and many patients and doctors trust the drug, meaning that newer blood thinners such as Pradaxa have a difficult time competing. To combat public bias towards warfarin, Pradaxa was marketed as a superior anticoagulant because it requires less blood monitoring and fewer dietary changes. Blood monitoring and dietary restrictions are warfarin’s biggest complaints, and Pradaxa marketing aimed to capitalize on those disappointments.

However, Pradaxa has allegedly fallen short of its promising marketing campaign and has been linked with reports of Pradaxa uncontrollable bleeding. In Pradaxa’s first three months on the market, the FDA received 307 reports of Pradaxa bleeding. Within the first year, 260 Pradaxa bleeding events reportedly resulted in death. Following the numerous reports, the FDA alerted consumers and physicians of the potential risk for Pradaxa uncontrollable bleeding, but no recall has been made.

Patients have reported a variety of bleeding events and complications while on Pradaxa, including internal bleeding, kidney bleeding, gastrointestinal bleeding, heart attack, stroke, brain hemorrhage, and death. Symptoms of Pradaxa uncontrollable bleeding will vary depending on the location and severity of the bleed, but any unusual bleeding symptoms could be a sign of a more serious problem.

In October 2015, an antidote for Pradaxa uncontrollable bleeding known as Praxbind was approved under accelerated approval by the FDA. In April 2018, Praxbind received full approval and became available in more hospitals. Before Praxbind was released, Pradaxa uncontrollable bleeding had to be managed through dialysis and blood transfusions, both of which are dangerous and not sure to work.

Although this will benefit the safety of patients from now on, numerous patients suffered from Pradaxa uncontrollable bleeding, complications, and death before the antidote was released.

Consumers who experienced a life threatening bleeding event while on Pradaxa may be able to file a lawsuit against Boehringer. These lawsuits often argue that the manufacturer did not properly warn patients and physicians of the risk associated with Pradaxa uncontrollable bleeding. Other plaintiffs claim that Boehringer knew or should have know about the risks, but released misleading safety materials to cover the risks up.

Boehringer has already settled numerous Pradaxa lawsuits, but further compensation may be available for those who did not participate in the original settlement. If you or a loved one suffered from Pradaxa uncontrollable bleeding, you may be eligible for legal action. A Pradaxa lawsuit could help recover compensation for medical bills, pain and suffering, loss of consortium, wrongful death, and more.