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Drug development research in pregnant and lactating women.

Authors
  • Ren, Zhaoxia1
  • Bremer, Andrew A2
  • Pawlyk, Aaron C3
  • 1 Obstetric and Pediatric Pharmacology and Therapeutics Branch, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD. Electronic address: [email protected]
  • 2 Pediatric Growth and Nutrition Branch, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD; Pregnancy and Perinatology Branch, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.
  • 3 Obstetric and Pediatric Pharmacology and Therapeutics Branch, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.
Type
Published Article
Journal
American journal of obstetrics and gynecology
Publication Date
Jul 01, 2021
Volume
225
Issue
1
Pages
33–42
Identifiers
DOI: 10.1016/j.ajog.2021.04.227
PMID: 33887238
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

Pregnant and lactating women are considered "therapeutic orphans" because they generally have been excluded from clinical drug research and the drug development process owing to legal, ethical, and safety concerns. Most medications prescribed for pregnant and lactating women are used "off-label" because most of the clinical approved medications do not have appropriate drug labeling information for pregnant and lactating women. Medications that lack human safety data on use during pregnancy and lactation may pose potential risks for adverse effects in pregnant and lactating women as well as risks of teratogenic effects to their unborn and newborn babies. Federal policy requiring the inclusion of women in clinical research and trials led to considerable changes in research design and practice. Despite more women being included in clinical research and trials, the inclusion of pregnant and lactating women in drug research and clinical trials remains limited. A recent revision to the "Common Rule" that removed pregnant women from the classification as a "vulnerable" population may change the culture of drug research and drug development in pregnant and lactating women. This review article provides an overview of medications studied by the Obstetric-Fetal Pharmacology Research Units Network and Centers and describes the challenges in current obstetrical pharmacology research and alternative strategies for future research in precision therapeutics in pregnant and lactating women. Implementation of the recommendations of the Task Force on Research Specific to Pregnant Women and Lactating Women can provide legislative requirements and opportunities for research focused on pregnant and lactating women. Published by Elsevier Inc.

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