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Pradaxa® Clinical Trial Aborted Due to Health Risks Posed for Study Participants Using Pradaxa®

According to a recent study published in the New England Journal of Medicine, patients with mechanical heart valves who were treated with Pradaxa® in a clinical trial suffered more instances of strokes, heart attacks, and bleeding problems than those patients treated with warfarin – which is a blood thinning medication that has been the standard anticoagulant used to treat patients with mechanical heart valves.

Although Pradaxa® was introduced as a superior stroke prevention alternative to warfarin, a growing number of reports raise concerns over uncontrollable bleeding problems and heart attacks associated with Pradaxa®. This latest study published in the New England Journal of Medicine bolsters those concerns. In a clinical trial, known as RE-ALIGN, researchers compared use of Pradaxa® (dabigatran) versus use of warfarin for patients with mechanical heart valves. According to one researcher, Elaine M. Hylek, the study was sponsored by Boehringer Ingelheim and sought to validate Boehringer Ingelheim’s claim that Pradaxa® is more effective than warfarin for the prevention of thromboembolism in patients with mechanical heart valves. The results of the study, however, showed otherwise. In particular, the RE-ALIGN study indicated that Pradaxa® was not as effective as warfarin for the prevention of thromboembolic complications in patients with mechanical heart valves and was associated with an increased risk of bleeding. The trial was eventually terminated at an early stage because of the health risks posed to the patients in the Pradaxa® group.

Pradaxa® is a relatively new blood thinning medication manufactured by the German-based pharmaceutical company Boehringer Ingelheim. It was approved by the FDA in 2010 as a blood thinning medication used to lower the chance of stroke in patients with non-valvular Atrial fibrillation (AF or A-fib). In 2011, the U.S. Food and Drug Administration initiated a formal investigation into serious bleeding events associated with Pradaxa®. Unlike other blood thinners, such as Warfarin, there is no known reversal agent or antidote for Pradaxa®. As such, Pradaxa® may cause excessive and serious bleeding that sometimes leads to death. A March 2012 article published in the New England Journal of Medicine pointed out that the lack of an effective reversal agent is an important concern. In September 2012, the Journal of the American College of Cardiology published a multicenter prospective study, which concluded that patients using Pradaxa® experience a significant increase in the risk of bleeding complications compared with patients treated using warfarin therapy.

As of August 15, 2013, over 1,340 federal lawsuits are currently pending against the drug’s manufacturers in the United States District Court for the Southern District of Illinois before the Honorable Chief Judge David R. Herndon. These individuals allege that they have suffered severe – and often fatal – injuries while using Pradaxa® and that Boehringer Ingelheim failed to adequately warn about bleeding risks or the lack of a reversal agent. All Pradaxa® lawsuits pending in federal court have been consolidated in the Southern District of Illinois in the Multidistrict Litigation In re: Pradaxa® (Dabigatran Etexilate) Products Liability Litigation (MDL 2385) for streamlined pre-trial proceedings. The first bellwether trial is set for August 2014.

Schlichter, Bogard & Denton, LLP are leaders in the national Pradaxa® Multidistrict Litigation (MDL 2385) against the makers of Pradaxa®. Partner Roger Denton has been appointed by Judge Herndon to serve as Plaintiffs’ Co-Lead Counsel in the Pradaxa® MDL. If you or a loved one have experienced complications from Pradaxa®, please contact the experienced attorneys at Schlichter, Bogard & Denton, LLP toll-free at 1-800-873-5297 for your confidential and free consultation.


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