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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
Study Summary

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

Result(s) (1)
Dabigatran (Pradaxa), Warfarin and Gastrointestinal Bleed, Intracerebral Hemorrhage
Regulatory Link(s) (1)
Update on the Risk for Serious Bleeding Events with the Anticoagulant Pradaxa (Dabigatran)
Related Publication(s) and/or Presentation(s) (1)
Publication: Dabigatran and Postmarketing Reports of Bleeding