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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
    Regulatory Determination / Use

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