FDA Perspective Published in The New England Journal of Medicine Reinforces Safety of Boehringer Ingelheim Corporation's Pradaxa® (dabigatran etexilate)

INGELHEIM, Germany--(BUSINESS WIRE)--A new perspective from the U.S. Food and Drug Administration (FDA) published in the New England Journal of Medicine1 states that the agency has not changed its recommendations regarding Pradaxa® (dabigatran etexilate), following the November 2012 Mini-Sentinel evaluations.2 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-LY® trial.1-4 The perspective was published online on March 13, 2013.