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Review
. 2025 Aug;170(2):568-575.
doi: 10.1002/ijgo.70076. Epub 2025 Mar 22.

Off-label use of drugs in pregnancy: A critical review of guidelines, current practices, and a clinical perspective

Vitalba Gallitelli  1 , Rita Franco  1 , Sofia Guidi  2 , Simona Zaami  3 , Marco Parasiliti  1 , Annalisa Vidiri  4 , Federica Perelli  5   6 , Francesco Plotti  1   7 , Georgios Eleftheriou  8 , Alberto Mattei  5 , Giovanni Scambia  9 , Anna Franca Cavaliere  9
Affiliations
Review

Off-label use of drugs in pregnancy: A critical review of guidelines, current practices, and a clinical perspective

Vitalba Gallitelli et al. Int J Gynaecol Obstet. 2025 Aug.

Abstract

Objective: The objective of this narrative review was twofold: to delineate the usage patterns of the main off-label drugs during pregnancy (i.e., misoprostol, nifedipine, and corticosteroids) and to offer a medical examiner's perspective on the use of these medications.

Methods: An extensive review of the literature was performed to assess the off-label use of corticosteroids, nifedipine, and misoprostol in pregnancy.

Results: Overall, 503 records about the use of off-label medicines during pregnancy were identified. After the exclusion of papers published in languages other than English and experimental studies in animals, 340 studies were considered eligible. Studies with medicines other than corticosteroids, misoprostol, and nifedipine were removed, leaving a total of 240 articles. From the remaining records, 24 reports were not retrieved. The research strategy allowed the final identification of 76 references.

Conclusion: Off-label drug use in obstetrics has transitioned from being an exception to a routine, scientifically validated practice. While its application is justified by clinical outcomes and international protocols, healthcare providers must navigate a strict framework of ethical and legal responsibility.

Keywords: corticosteroid; drugs; misoprostol; nifedipine; off‐label; perinatal; pregnancy.

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References

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