Dabigatran and Postmarketing Reports of Bleeding

From the Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD.
New England Journal of Medicine (Impact Factor: 54.42). 03/2013; 368(14). DOI: 10.1056/NEJMp1302834
Source: PubMed

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 . . .

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