FDA Rules for Pregnancy and Lactation Labeling and Their Clinical Implications

  • Lauren M. OsborneEmail author
  • Nicole Leistikow
  • Renan Rocha


The new Food and Drug Administration (FDA) system for the use of drugs in pregnancy and lactation came into effect in 2015. The label content and format were reformulated, and any references to categories A, B, C, D, and X were removed and replaced by a summary of the perinatal risks of the substance, a discussion about the scientific data, and a synthesis of its relevance for medical treatment. The ultimate goal of the new standards is to facilitate the prescribing process by offering a consistent and well-structured set of information regarding the use of medications during pregnancy and lactation. The prior FDA category system had unintended effects on the perception and use of psychotropic medications in pregnancy and breastfeeding and contributed to a widespread overemphasis on the risks of these medications alongside a failure to appreciate the risks of untreated mental illness for women and babies. The clincial effect of the old categories in combination with stigma and lack of well designed research was likely the undertreatment of severe mental illness in pregnancy. The new FDA narrative summaries attempt to remedy these errors but require a high degree of medical knowledge about reproductive psychiatry and the evidence-based literature on the part of physcians and other providers. Specific medical training in the treatment of pregnant women with mental illness is a pressing need.


Food and Drug Administration FDA Label Pregnancy Lactation Perinatal Drugs Stigma Safety Risk 


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Copyright information

© Springer Nature Switzerland AG 2020

Authors and Affiliations

  • Lauren M. Osborne
    • 1
    Email author
  • Nicole Leistikow
    • 2
  • Renan Rocha
    • 3
  1. 1.Women’s Mood Disorders Center, The Johns Hopkins University School of MedicineBaltimoreUSA
  2. 2.Division of Consultation-Liaison, Department of PsychiatryUniversity of Maryland School of MedicineBaltimoreUSA
  3. 3.Private Practice, São Lucas Medical Institute CriciúmaSanta CatarinaBrazil

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