Eliquis (Apixaban), Pradaxa (Dabigatran), and Xarelto (Rivaroxaban) & Gastrointestinal Bleeding, Intracranial Hemorrhage, Major Extracranial Bleeding, and Thromboembolic Stroke

    Basic Details
    Status
    Ongoing
    Last Updated
    Friday, October 30, 2020
    Health Outcome(s)
    gastrointestinal bleeding
    intracranial hemorrhage
    major extracranial bleeding
    thromboembolic stroke
    Purpose
    Drug and Outcome Analysis
    Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
    No