Pradaxa has Woefully Inadequate Warnings and Precautions About Serious Bleeding Risks

Despite the serious risks associated with daily usage of Pradaxa, Boehringer Ingelheim, the drugs creator, fails to adequately warn patients of the dangers involved. Evidence of this claim is demonstrated when reviewing a study issued by the Institute for Safe Medication Practices, which reported that out of the 272,119 prescriptions issued for Pradaxa in the first quarter of 2011 alone, 932 reports of serious adverse drug events were reported. For the quarter, this was the highest total for any drug monitored by the study with one exception. Notwithstanding such data, BI has continually concealed knowledge of Pradaxa’s life – threatening risk of irreversible bleeds, as the warnings provided by the company are insufficient in scope and literal size (on the precaution labels). No serious effort was made to inform patients or the larger medical community of how to intervene and stabilize a patient in the event of a bleed, nor of the fact that Pradaxa has no known “reversal agent.” Additionally, Pradaxa still lacks a “black box” warning patients or their doctors that the drug can cause sudden and irreversible bleeds. While some recent label changes have been made to better inform Pradaxa users and doctors of the risks involved, they are wholly inadequate in their viewing potential and scope.

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