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Infed (Iron Dextran), Venofer (Iron Sucrose), Feraheme (Ferumoxytol), Injectafer (Ferric Carboxymaltose), Monoferric (Ferric Derisomaltose) & Exposure in Pregnancy

    Basic Details
    Last Updated
    Tuesday, October 13, 2020
    Health Outcome(s)
    exposure in pregnancy
    Drug Use
    Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
    Regulatory Determination / Use

    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.