After receiving approximately 50 reports of fatal bleeding cases linked to the use of Pradaxa (dabigatran), the the U.S. Food and Drug Administration announced that it will conduct a complete safety review of the drug. Pradaxa is an oral direct thrombin inhibitor that is used to prevent stroke in patients suffering from nonvalvular atrial fibrillation. The FDA’s safety review will allow the agency to better determine whether or not the reports of bleeding are occurring more commonly than would be expected.
Originally approved by the FDA in October 2010, the agency limited the drug’s approval to only two doses, the 150mg bid and 75mg bid. This limitation was questioned due to the fact the 75mg dose had never actually been formally tested in clinical trials. In fact, an article published in the New England Journal of Medicine reported commentary from FDA researchers that specifically noted a “prevailing concern about the potential for excess bleeding.”
The drug’s maker, Boehringer Ingelheim, maintains that Pradaxa’s safety profile was in line with what had been seen in its clinical trials.
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