The U.S. Food and Drug Administration (FDA) today announced the results of a Mini-Sentinel assessment that indicates bleeding rates associated with new use of Pradaxa® (dabigatran etexilate mesylate) capsules do not appear to be higher than bleeding rates associated with new use of warfarin, which is consistent with observations from the pivotal RE-LY® trial.
The Mini-Sentinel assessment evaluated new information about the risk of serious bleeding associated with use of the anticoagulants (blood thinners) PRADAXA and warfarin. FDA 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. This assessment was done using insurance claims and administrative data from the FDA's ongoing Mini-Sentinel pilot of the Sentinel Initiative.
"The findings of the FDA Mini-Sentinel support the safety of PRADAXA when used as directed, and reaffirm the results of our pivotal RE-LY trial," said Sabine Luik, MD, PhD, Sr. Vice President, Medicine & Regulatory Affairs, US Regional Medical Director, NA, Boehringer Ingelheim Pharmaceuticals, Inc. "We believe these findings provide important information for healthcare professionals and patients as they consider the benefits and risks of anticoagulation therapy."
Boehringer Ingelheim will present data from 16 abstracts at the American Heart Association's (AHA) Scientific Sessions in Los Angeles from November 3 to 7, 2012, including new safety data on PRADAXA. These data reinforce BI's commitment to adding to the scientific body of evidence for PRADAXA and stroke prevention in NVAF.