Call Us: 1.800.873.5297

By

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.

 

Legal Disclaimer: The choice of a lawyer is an important decision and should not be based solely on advertisements. The cases discussed do not predict outcomes in future cases. Past results afford no guarantee of future results and every case is different and must be judged on its own merits.

000-017   000-080   000-089   000-104   000-105   000-106   070-461   100-101   100-105  , 100-105  , 101   101-400   102-400   1V0-601   1Y0-201   1Z0-051   1Z0-060   1Z0-061   1Z0-144   1z0-434   1Z0-803   1Z0-804   1z0-808   200-101   200-120   200-125  , 200-125  , 200-310   200-355   210-060   210-065   210-260   220-801   220-802   220-901   220-902   2V0-620   2V0-621   2V0-621D   300-070   300-075   300-101   300-115   300-135   3002   300-206   300-208   300-209   300-320   350-001   350-018   350-029   350-030   350-050   350-060   350-080   352-001   400-051   400-101   400-201   500-260   640-692   640-911   640-916   642-732   642-999   700-501   70-177   70-178   70-243   70-246   70-270   70-346   70-347   70-410   70-411   70-412   70-413   70-417   70-461   70-462   70-463   70-480   70-483   70-486   70-487   70-488   70-532   70-533   70-534   70-980   74-678   810-403   9A0-385   9L0-012   9L0-066   ADM-201   AWS-SYSOPS   C_TFIN52_66   c2010-652   c2010-657   CAP   CAS-002   CCA-500   CISM   CISSP   CRISC   EX200   EX300   HP0-S42   ICBB   ICGB   ITILFND   JK0-022   JN0-102   JN0-360   LX0-103   LX0-104   M70-101   MB2-704   MB2-707   MB5-705   MB6-703   N10-006   NS0-157   NSE4   OG0-091   OG0-093   PEGACPBA71V1   PMP   PR000041   SSCP   SY0-401   VCP550  

Legal Disclaimer & Privacy Policy
This web site is designed for general information only. The information presented should not be construed as legal advice and does not form the basis for an attorney/client relationship.

The choice of a lawyer is an important decision and should not be based solely on advertisements.
This web site is not intended to be advertising, and Schlichter Bogard & Denton LLP does not desire to represent anyone desiring representation based upon viewing this web site in a jurisdiction where this web site fails to comply with all laws and ethical rules of that jurisdiction. Materials on this web site may only be reproduced in their entirety (without modification) for the individual reader's personal and/or educational use and must include this notice.

We will not disclose, sell, or rent any of your identifiable personal information to any third party, unless approved by you, or required by law.