Perspective from The New England Journal of Medicine: Dabigatran and Postmarketing Reports of Bleeding

    Basic Details
    Date
    Thursday, April 4, 2013
    Type
    Publication
    Medical Product
    anticoagulant
    blood thinner
    dabigatran
    Health Outcome(s)
    gastrointestinal hemorrhage
    intracerebral hemorrhage (ICH)
    serious bleeding
    Description

    This article describes FDA’s use of a Mini-Sentinel modular program-based one-time assessment of the risk of gastrointestinal hemorrhage (GIH) or intracerebral hemorrhage (ICH) events associated with use of the anticoagulants (blood thinners) dabigatran and warfarin in the Mini-Sentinel Distributed Database. Modular programs are adaptable standardized programs.

    Information
    Time Period
    2006-2011
    Population / Cohort
    with/without pre-existing atrial fibrillation
    Data Source(s)
    Mini-Sentinel Distributed Database (MSDD)
    Author(s)

    Mary Ross Southworth PharmD; Marsha E. Reichman PhD; Ellis F. Unger MD