New Changes in Pregnancy and Lactation Labeling: Review of Dermatologic Drugs

    May 2019 in “ International Journal of Women's Dermatology ”
    Yun Pei Koh, Elizabeth Ai Lian Tian, Hazel H Oon
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    TLDR The new FDA labeling rules provide more detailed drug safety information for pregnant and breastfeeding women, but more data is needed on the risks of many dermatologic drugs.
    The document from 2019 reviewed the updated FDA pregnancy and lactation labeling rules for dermatologic drugs, which offer detailed information on drug use during pregnancy, breastfeeding, and effects on fertility. It categorized common dermatologic drugs based on available literature up to November 2018, including topical and systemic treatments for various skin conditions. The new labeling rules, which replaced the previous letter risk categories, aim to improve prescribing decisions by providing a narrative format that considers various factors impacting reproductive potential. The review found that while some drugs are safe for use during pregnancy and lactation, others require caution or are contraindicated, and there is a need for more data to fully understand the risks associated with many of these drugs. The FDA's reclassification is intended to enhance patient care by informing better clinical decisions for pregnant and breastfeeding women, as well as individuals of reproductive potential.
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