Safety Review Ordered for Pradaxa

The U.S. Food and Drug Administration announced this week that it will conduct a complete safety review of the drug, Pradaxa (dabigatran), following reports that it may cause excessive bleeding. 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 announcement comes just one month after its receipt of almost 50 cases of fatal bleeding incidents linked to Pradaxa were reported.

In October 2010, the FDA limited its approval of the drug to two doses, 150mg bid and 75mg bid. This limitation was somewhat alarming given 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.”

Boehringer Ingelheim, the drug’s maker, maintains that Pradaxa’s safety profile was in line with what had been seen in its clinical trials.

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