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The importance of investigating the effects of drug therapy on maternal breast milk composition

Pediatric Research volume 97, pages 1765–1766 (2025)Cite this article

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Breast milk is the optimal nutrition for all newborns with few recommendations limiting its use. The American Academy of Pediatrics recommends exclusive breastfeeding throughout the first six months of life with continued breast milk exposure throughout the first two years of life or beyond at the discretion of the mother.1 Contraindications to breast feeding are sparse and are limited to active, deleterious viral infections transmittable via breast milk,2 polysubstance abuse,3 and medication use by the mother deemed toxic to the newborn.4 To date, the majority of drug safety data for lactating mothers are informed by transmission of the drug into breastmilk, with little consideration for the impact of the drug on downstream milk composition. In contrast, Sepiashivili et al. put forth an alternative approach to assess drug safety during lactation, considering the drug’s effect on maternal milk composition, independent of drug transmission, on the developing newborn and infant.5

Tumor necrosis monoclonal antibodies (TNFmAb), including infliximab and adalimumab, are a common therapy for the treatment of inflammatory bowel disease (IBD). Although TNFmABs can cross the placenta, they are not excreted into human breast milk. Thus, with timed dosing during pregnancy to allow for appropriate immune response of the newborn at birth, treatment with TNFAb is a mainstay of therapy for pregnant and lactating women with IBD. Interestingly, pre-clinical research has raised the question as to whether a reduction in TNF and associated chemokine levels in breast milk could be neuroprotective to offspring.6 Despite lack of transmission into breast milk, TNFmAbs reduce production of TFN along with TNF associated chemokines in the mother, which translates into reduced TFN and chemokines in breast milk. While these proinflammatory biomarkers are viewed to be essential components in maternal breast milk for the developing infant immune system, mouse models have demonstrated improved neurodevelopment in offspring born to either knockout TNF mouse models or maternal mice receiving TNFmAb therapy during lactation,6 questioning whether inflammatory biomarkers have deleterious effects on the developing brain despite their essential role in a newborn’s immunity.

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  1. Pediatrician-in-Chief, Women & Infants Hospital of Rhode Island, Division of Newborn Medicine, 101 Dudley Street, Providence, RI, 02905, USA

    Jill L. Maron

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  1. Jill L. Maron
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Correspondence to Jill L. Maron.

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Maron, J.L. The importance of investigating the effects of drug therapy on maternal breast milk composition. Pediatr Res 97, 1765–1766 (2025). https://doi.org/10.1038/s41390-024-03785-1

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