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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.
The medical community has pointed out several key problems with Boehringer Ingelheim´s trials. The many flaws include:
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.
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.