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
    Image of study
    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.
    Discuss this study in the Community →

    Research cited in this study

    5 / 5 results

    Related Community Posts Join

    6 / 711 results

    Similar Research

    5 / 1000+ results
      A Review of Diagnosis and Treatment of Acne in Adult Female Patients

      research A Review of Diagnosis and Treatment of Acne in Adult Female Patients

      116 citations, December 2017 in “International Journal of Women's Dermatology”
      Adult female acne treatment should be personalized, considering individual preferences and pregnancy, using various topical and oral medications while managing side effects and resistance.
      Distinctive Acne Entities

      research Distinctive Acne Entities

      January 2019 in “Springer eBooks”
      Acne can appear or persist in adulthood due to hormonal changes, external factors, or substance use, and requires appropriate treatment.
      Guidelines for the Use of Acitretin in Psoriasis

      research Guidelines for the Use of Acitretin in Psoriasis

      25 citations, July 2013 in “Actas Dermo-Sifiliográficas”
      Acitretin is effective for severe psoriasis and can be used long-term due to no immunosuppression, but must be carefully monitored for side effects and is not for pregnant women.
      Androgenetic Alopecia: An Update Of Treatment Options

      research Androgenetic Alopecia: An Update Of Treatment Options

      110 citations, August 2016 in “Drugs”
      Minoxidil is the only FDA-approved topical drug for treating male or female pattern hair loss, and other medications like finasteride and dutasteride can also increase hair growth.