Pradaxa (Dabigatran Etexilate) & Gastrointestinal (GI) Bleed and Intracranial Hemorrhage

Basic Details
Status
Complete
Last Updated
Wednesday, January 24, 2018
Health Outcome(s)
gastrointestinal (GI) bleed
intracranial hemorrhage
Purpose
Mini-Sentinel
Regulatory Determination / Use

FDA decided that no action is necessary at this time, based on available information.