FDA Labeling Change: Parenteral Iron Products and Risk of Severe Adverse Reactions to Pregnant Women and their Fetuses

    Basic Details
    Date
    Friday, September 11, 2020
    Communication Type
    Labeling Change
    FDA Center
    CDER
    Medical Product
    Feraheme (ferumoxytol)
    Infed (iron dextran)
    Injectafer (ferric carboxymaltose)
    Monoferric (ferric derisomaltose)
    Venofer (iron sucrose)
    Health Outcome(s)
    exposure in pregnancy
    Description

    This analysis characterized the frequency of IV iron utilization by week relative to live birth and stillbirth deliveries. Information from this analysis contributed to a class-wide labeling update for parenteral iron products to add new safety information to the Use in Specific Populations, Pregnancy section of the label. This update describes the risk of severe adverse reactions to pregnant women and their fetus.