Pradaxa, or dabigatran, is an anticoagulant that is part of the class of direct thrombin inhibitors. Pradaxa is manufactured by the Germany company, Boehringer Ingleheim. The drug was FDA approved in October of 2010 for treatment of stroke in patients with non-valvular atrial fibrillation. It was then approved in 2014 to treat deep venous thrombosis (DVT) and pulmonary embolism.
However, shortly after approval, the FDA began receiving complaints and reports of serious bleeding by those who had used the medication. As of 2010, the FDA has received over 4,000 reports of adverse effects and more than 500 deaths among those who have used the drug. In December of 2011, the FDA announced that is planned to look into the risks associated with use of Pradaxa, particularly the risk of bleeding. In November of 2012, the FDA released a Safety Announcement in which they did not change their recommendation regarding Pradaxa, and still believe it has “an important health benefit.”
A study published in the New England Journal of Medicine in September of 2013, found that the use of dabigatran in patients with mechanical heart valves was “associated with increased rates of thromboembolic and bleeding complications, as compared with warfarin, thus showing no benefits and an excess risk.”
In May of 2014, the FDA reported on a clinical study comparing dabigatran to warfarin in Medicare patients. The study noted that gastrointestinal bleeding was more common in those treated with Pradaxa than those with warfarin; however, the agency opinioned that Pradaxa’s overall risk/benefit ratio was more favorable than warfarin’s.
In July 2014, the British Medical Journal (BJM) published a series of investigations and found that recommendations for use of Pradaxa may be flawed because regulators did not see evidence regarding monitoring of drug plasma levels. The series claims that the maker of Pradaxa, Boehringer, had extensive analyses that showed how the internal bleeding risk may be reduced, specifically involving plasma levels. Yet, the company has not shared the information with either doctors or regulators according to The BJM.
Those injured by Pradaxa began filing lawsuits. The mass of lawsuits grew to more than 4,000 by 2014, and Boehringer settled many of the lawsuits for $650 million that year. However, many others have been seriously injured by the use of Pradaxa, and lawyers are taking new cases against the drug maker.