FDA confirms views that Boehringer's Pradaxa bleeding rates no higher than for warfarin

A new perspective from the US Food and Drug Administration states the agency has not changed its recommendations regarding German family-owned drug major Boehringer Ingelheim’s Pradaxa (dabigatran etexilate mesylate) capsules, following the November 2012 Mini-Sentinel evaluations.

The FDA stated that bleeding rates associated with new use of Pradaxa do not appear to be higher than those with new use of warfarin, which is consistent with observations from the pivotal RE-LYtrial. The perspective was published online on March 13, 2013 in the New England Journal of Medicine (NEJM).

The Mini-Sentinel evaluated information about the risk of serious bleeding associated with the use of blood thinners (anticoagulants): Pradaxa and warfarin. The FDA investigated the rates of bleeding occurring in the stomach and intestines (gastrointestinal bleeding) and a type of bleeding in the brain (intracranial hemorrhage) for new users of Pradaxa compared to new users of warfarin. This assessment was done using insurance claims and administrative data from the FDA's ongoing Mini-Sentinel pilot of the Sentinel Initiative.