Complementary use of Passive Surveillance and Mini-Sentinel to Better Characterize Hemolysis after Immune Globulin

    Basic Details
    Date
    Tuesday, July 14, 2015
    Type
    Publication
    Medical Product
    intravenous immune globulin (IGIV)
    Health Outcome(s)
    hemolysis
    Description

    This article describes a project that used Mini-Sentinel data to expand FDA’s understanding of hemolysis post- intravenous immune globulin (IGIV) administration.

    Author(s)

    Scott K. Winiecki MD; Bethany Baer MD; Wambui Chege MD; Christopher Jankosky MD; Paul D. Mintz MD; Meghan A. Baker MD, ScD; Tiffany S. Woodworth MPH; Michael D. Nguyen MD

    Corresponding Author

    S. Winiecki, FDA Center for Biologics Evaluation and Research, 10903 New Hampshire Avenue, WO71-1025, Silver Spring, MD; e-mail: scott.winiecki@fda.hhs.gov