Boehringer Ingelheim, the company that makes Pradaxa (dabigatran), has admitted that the clinical trial data used to obtain approval for the drug neglected to include almost 2 dozen reports of major bleeding episodes. The revelation comes as the company faces thousands of Pradaxa lawsuits alleging that it failed to provide adequate warnings about the risk of uncontrollable bleeding events and the lack of an antidote for the blood thinner.
Free Pradaxa Lawsuit Evaluation: If you or a loved one has been injured by Pradaxa, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.
Reevaluation of Pradaxa Study Results
On May 14, 2014, Boehringer Ingelheim issued a press release stating that it had discovered the undisclosed bleeding incidents during a review of the RE-LY study, which was used to establish that Pradaxa is safe for preventing strokes in patients with atrial fibrillation (a-fib). The additional bleeding events were reportedly identified during the re-evaluation. However, Boehringer maintains that this does not change the conclusions reached by RE-LY.
What was RE-LY?
The RE-LY study included 18,000 test subjects who were treated with either Pradaxa or warfarin, a staple anticoagulant that has been in use for more than 50 years in the United States. The trial was performed by a research team at the Population Health Research Institute in Ohio, and compared the safety profile of the medications when used for the prevention of stroke in patients with a-fib.
Boehringer recently conducted its own analysis of RE-LY after learning about previously uncategorized bleeding episodes during the Pradaxa litigation. At least 22 such incidents were discovered during the re-evaluation, including 5 that involved patients taking a 110 mg dose of Pradaxa, 11 in those who used a 150 mg dose, and 6 for patients treated with warfarin.
Accuracy of Trial Results Questioned
As a result of these problems, a number of questions have been raised regarding the accuracy of RE-LY. The study was published in September of 2009, and has already been amended at least once. Little more than a year after the trial results were published, the study’s authors issued a correction, admitting they had left out some bleeding events and other side effects that had somehow been overlooked. At least 81 complications in 80 patients – including bleeding episodes, blood clots, heart attacks and at least 1 stroke, were found to have been left out of the results even before the revelation by Boehringer.
RE-LY’s findings were further questioned in October of 2011, by a research team at the University of British Columbia (UBC), who sent a letter to Therapeutics Initiative, warning that the study was inherently flawed. The team determined that Pradaxa was approved prematurely, and that it is not safe for use with many patient populations. The researchers also concluded that an independent audit of RE-LY needs to be performed to look for irregularities in the conduct, bias and test results.
FDA: Pradaxa Linked to Gastrointestinal Bleeding
Also in May 2014, the U.S. Food & Drug Administration (FDA) announced that a Pradaxa safety review had identified an increased risk of gastrointestinal bleeding in patients treated with the drug compared to those treated with warfarin. However, FDA also determined that Pradaxa appeared to lower the risk of stroke and had roughly the same mortality rate.
Do I Have a Pradaxa Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Pradaxa lawsuits. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.
Free Confidential Case Evaluation: Again, if you or a loved one was injured by Pradaxa, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.