Exposure to Intravenous (IV) Iron Procedures and Anaphylaxis and Epinephrine Events

    Basic Details
    Date Posted
    Friday, March 2, 2018
    Status
    Complete
    Medical Product
    intravenous (IV) iron
    Health Outcome(s)
    anaphylaxis
    epinephrine event
    Description

    Mini-Sentinel's IV Iron Workgroup requested execution of Modular Program #3 (MP3) to investigate exposure to IV iron procedures and anaphylaxis and epinephrine events for individuals with and without a pre-existing condition of dialysis. This involved one run of MP3. The time window for the request is January 1, 2000 – December 31, 2012. The package was distributed to Data Partners on January 17, 2013.

    Additional Details
    FDA Center
    CDER
    Time Period
    January 1, 2000 - December 31, 2012
    Study Type
    Modular Program
    Assessment Type
    Safety Analyses
    Population / Cohort
    All individuals
    Data Sources
    Mini-Sentinel Distributed Database (MSDD)