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

Basic Details
Date
Thursday, April 4, 2013
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.

Materials

The New England Journal of Medicine, Volume 368, Issue 14, April 2013, Pages 1272-1274, DOI: 10.1056/NEJMp1302834

Information
Time Period
2006-2011
Population / Cohort
with/without pre-existing atrial fibrillation
Data Source(s)
Mini-Sentinel Distributed Database (MSDD)
Related Assessment(s)
Dabigatran (Pradaxa), Warfarin and GI Bleed, Intracerebral Hemorrhage
Author(s)

Mary Ross Southworth PharmD; Marsha E. Reichman PhD; Ellis F. Unger MD

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