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

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

    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
    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)