Use of Dabigatran and Intracranial Hemorrhage, Gastrointestinal Hemorrhage, Ischemic Stroke, and Acute Myocardial Infarction

Basic Details
Date Posted
Friday, August 17, 2018
Medical Product
Health Outcome(s)
acute myocardial infarction (AMI)
gastrointestinal hemorrhage
intracranial hemorrhage
ischemic stroke

These reports contain evaluations of the association between dabigatran and various outcomes, with warfarin as the comparison. The outcomes of interest include intracranial hemorrhage, gastrointestinal hemorrhage, ischemic stroke, and acute myocardial infarction. The reports display data on individuals 21 years of age and older and on individuals 65 years of age and older. Additionally, each dabigatran and outcome pair was assessed with a 183-day washout period and a 365-day washout period. See the specific deliverables for what is contained in each report. These queries were distributed to Data Partners in July 2015, and they contain data between November 1, 2010 through December 31, 2013 from the Mini-Sentinel Distribtued Database.

Additional Details
FDA Center
Time Period
November 1, 2010 - December 31, 2013
Study Type
Modular Program
Assessment Type
Safety Analyses
Population / Cohort
Individuals 21 years of age and older; individuals 65 years of age and older
Data Sources
Mini-Sentinel Distributed Database