The U.S. Food and Drug Administration (FDA) recently published a report about the safety of Pradaxa in The New England Journal of Medicine. The article’s intention was to more thoroughly examine the health risks associated with Pradaxa use, especially in light of the increasing reports linking Pradaxa to excessive bleeding and death.
The study that won Pradaxa FDA approval in October 2010, the Randomized Evaluation of Long-Term Anticoagulation Therapy, or RE-LY, trial compared Pradaxa to warfarin. The RE-LY trial results concluded there to be no difference in bleeding risk between Pradaxa and warfarin.
Despite these results from the RE-LY trial, the FDA began to receive a significant amount of adverse event reports associated with Pradaxa shortly following its approval. The ever-increasing number of adverse event reports soon raised red flags about the safety of using Pradaxa, according to a Forbes report.
In light of these adverse event reports, the FDA sought to re-examine the injury risk of using Pradaxa. After conducting its own analysis using the Mini-Sentinel database, with similar results to the RE-LY trial, the FDA chalked up the high number of Pradaxa linked injuries to the drug’s new status. They point to frequent media coverage as a driving factor behind Pradaxa users submitting reports to the FDA.
In concluding their article, the FDA advised that despite the fact that Pradaxa does not have a reversal agent, like warfarin does in vitamin K, there still remain benefits in using Pradaxa.
Carey Danis & Lowe still considers Pradaxa to be a drug that poses serious injury due to the lack of a reversal agent. Furthermore, Pradaxa was originally intended to replace warfarin, and appears to be no better than it in light of a nonexistent panacea for excessive bleeding.
Carey Danis & Lowe is closely examining the association between media coverage, Pradaxa adverse event reports, and the FDA’s stance on Pradaxa safety. If you or someone you love has been injured by Pradaxa, contact a Pradaxa lawyer at Carey Danis & Lowe for a free legal evaluation and to file a Pradaxa lawsuit.
Contact Carey Danis & Lowe by phone at 800.721.2519 or by submitting a legal claim form.References: Pharmaceutical litigation, Pradaxa