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

Project Title Perspective from The New England Journal of Medicine: Dabigatran and Postmarketing Reports of Bleeding
Date
Thursday, April 4, 2013
Location
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.

Medical Product
anticoagulant
blood thinner
dabigatran
Health Outcome
gastrointestinal hemorrhage
intracerebral hemorrhage (ICH)
serious bleeding
Population / Cohort
with/without pre-existing atrial fibrillation
Time Period
2006-2011
Authors

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

Data Sources
Mini-Sentinel Distributed Database (MSDD)
Related Assessments