Manufacturer Boehringer Ingelheim has claimed that they used clinical trials and studies (“PETRO,” “PETRO Extension,” and “RE-LY”) to adequately test the safety of Pradaxa. The largest and most touted of these clinical trials was RE-LY. This two-year study compared Pradaxa to a similar predecessor medication, warfarin, in reducing the risk of stroke and systemic embolism for patients with irregular heartbeats. Boehringer Ingelheim heavily based their Food and Drug Administration (FDA) approval application on this study, but more recent analyses of these studies show irregularities and have sparked concerns as to their accuracy.
Problems with the RE-LY Study
The medical community has pointed out several key problems with Boehringer Ingelheim´s trials. The many flaws include:
- Financial ties between the doctors running the study and Boehringer Ingelheim
- Initial under-reporting of the increased risk of myocardial infarction (heart attack)
- Failure to evaluate Pradaxa’s effects on patients with low body weight
- Not targeting the clinical trial to the age of patients most likely to use Pradaxa and other blood thinners (those over seventy-five)
- No evaluation of kidney problems (renal impairment) and their effect on the ability to remove Pradaxa from patients’ bodies
- Selective reporting of only the first bleeding instances in trial participants instead of the total number of bleeding instances
- Pushing the drug for approval without an effective way to remove it from the body in urgent situations such as uncontrolled bleeding
- Poor methodology in conducting the Pradaxa study (not using “double-blind” participants)
Flawed Studies Fail to Adequately Inform the Public of Pradaxa Bleeding Risks
With all of these problems now known, the validity of Boehringer Ingelheim´s study has come under intense and deserved criticism. Without a valid study to support its claims, doctors and patients were not be adequately informed of the risks associated with taking Pradaxa.
Moreover, the study was used by Pradaxa to gain approval in the U.S. and in Europe. Now that the truth has come out regarding the RE-LY Trial, decisions to approve Pradaxa for public use are being reevaluated, and Boehringer Ingelheim has come under intense scrutiny.
Let Our Experienced Pradaxa Attorneys Help You
The attorneys at Raizner Slania have significant experience with injury claims involving pharmaceutical drugs and prosecuting claims against pharmaceutical companies. Contact us today to speak with an experienced attorney to evaluate your potential Pradaxa injury or wrongful death claim.