Dabigatran and Postmarketing Reports of Bleeding

Abstract

In the months following the approval of the oral anticoagulant dabigatran (Pradaxa, Boehringer Ingelheim) in October 2010, the Food and Drug Administration (FDA) received through the FDA Adverse Event Reporting System (FAERS) many reports of serious and fatal bleeding events associated with use of the drug. Because dabigatran is an anticoagulant, reports of bleeding were anticipated, but the rate of reported incidents was unusually high and was greater than the concurrent rate of reported bleeding incidents with warfarin, which had been the anticoagulant of choice for nearly 60 years before dabigatran was approved. In contrast, the controlled trial that supported the approval of dabigatran (Randomized Evaluation of Long-Term Anticoagulation Therapy [RE-LY]), which compared warfarin with dabigatran in patients with nonvalvular atrial fibrillation,¹ showed that the two drugs conferred a similar risk of bleeding.