Serious bleeding risk with Boehringer's Pradaxa no worse than warfarin, says FDA

In a follow up to a 2011 safety communication, the US Food and Drug Administration has evaluated new information about the risk of serious bleeding associated with use of German family-owned drug major Boehringer Ingelheim’s anticoagulant Pradaxa (dabigatran etexilate), concluding that rates of gastrointestinal bleeding and intracranial hemorrhage were no higher in Pradaxa patients than in those using the older drug, warfarin, that it was designed to replace.

This follows the positive opinion adopted by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on the renewal of the marketing authorization for Pradaxa® in October, noted Boehringer Ingelheim

Following the approval of Pradaxa, the FDA said it received a large number of post-marketing reports of bleeding among Pradaxa users. As a result, the agency investigated the actual rates of gastrointestinal bleeding (occurring in the stomach and intestines) and intracranial hemorrhage (a type of bleeding in the brain) for new users of Pradaxa compared to new users of warfarin.