Parenteral Iron and Anaphylactoid Reactions

    Basic Details
    Date Posted
    Friday, July 22, 2016
    Status
    Complete
    Medical Product
    parenteral iron (IV iron)
    Health Outcome(s)
    anaphylactoid reaction
    Description

    This protocol will guide a one-time assessment of the association between parenteral iron products and anaphylactoid/anaphylactic reactions. Protocol-based assessments use study designs and analysis plans customized for the product-outcome pairs being assessed.

    This protocol was posted for public comment from September 4, 2013 through September 18, 2013. The public comment period is now closed. A revised version was approved for implementation by FDA on January 8, 2014. A log of changes is included in the revised protocol (v2.0).

    Additional Details
    FDA Center
    CDER
    Time Period
    2000 - 2012
    Study Type
    Protocol/Surveillance Plan
    Assessment Type
    Safety Analyses
    HOI Study Type
    Validations Supported by Traditional Medical Chart Review
    Population / Cohort
    All non-dialysis individuals
    Data Sources
    Mini-Sentinel Distributed Database (MSDD)
    Workgroup Leader(s)

    Kathleen Walsh MD, MSc; Cincinnati Children’s Hospital Medical Center, Cincinnati, OH

    Cunlin Wang MD, PhD; Center for Drug Evaluation and Research, FDA, Silver Spring, MD

    Workgroup Members

    Susan Andrade ScD; Joann Wagner MSW; Meyers Primary Care Institute and University of Massachusetts Medical School, Worcester, MA 

    Maryam Asgari MD, MPH; Kaiser Permanente Northern California, Oakland, CA

    Irene Fung MD; Peter Reese MD, MSCE; University of Pennsylvania School of Medicine, Philadelphia, PA

    Monika Houstoun PharmD, MPH; Robert Kane MD; Mark Levenson PhD; Marsha Reichman PhD; Qin Ryan MD, PhD; Diqiong Xie PhD, MS; Center for Drug Evaluation and Research, FDA, Silver Spring, MD

    Lingling Li PhD; Darren Toh ScD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

    Gayathri Sridhar PhD, MBBS, MPH; HealthCore Inc., Wilmington, DE