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Perspective from The New England Journal of Medicine: Dabigatran and Postmarketing Reports of Bleeding

Basic Details
Date
Type
Publication
Medical Product
anticoagulant
blood thinner
dabigatran
Health Outcome(s)
gastrointestinal hemorrhage
intracerebral hemorrhage (ICH)
serious bleeding
Description

This article describes FDA’s use of a Mini-Sentinel modular program-based one-time assessment of the risk of gastrointestinal hemorrhage (GIH) or intracerebral hemorrhage (ICH) events associated with use of the anticoagulants (blood thinners) dabigatran and warfarin in the Mini-Sentinel Distributed Database. Modular programs are adaptable standardized programs.