TabsDetailsBasic DetailsDate: Thursday, April 4, 2013Type: PublicationMedical Product: anticoagulant, blood thinner, dabigatranHealth Outcome(s): gastrointestinal hemorrhageintracerebral hemorrhage (ICH)serious bleedingDescription: 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. Read More Materials: The New England Journal of Medicine, Volume 368, Issue 14, April 2013, Pages 1272-1274, DOI: 10.1056/NEJMp1302834 Additional InformationInformationTime Period: 2006-2011Population / Cohort: with/without pre-existing atrial fibrillationData Source(s): Mini-Sentinel Distributed Database (MSDD)Related Assessment(s): Dabigatran (Pradaxa), Warfarin and GI Bleed, Intracerebral HemorrhageContributorsAuthor(s): Mary Ross Southworth PharmD; Marsha E. Reichman PhD; Ellis F. Unger MD