Maternal drugs and breastfeeding: Risk assessment from pharmacokinetics to safety evidence-A contribution from the ConcePTION project

Human milk is the most appropriate form of nutrition for infants while taking medication during the postpartum period is common. Discontinuation of breastfeeding is sometimes wrongly recommended for fear of adverse effects in the breastfed infant whereas only a few drugs are strictly contraindicated while breastfeeding. Most drugs are transferred from the mother's blood to the milk, but the breastfed infant usually ingests a small drug amount through human milk. As population-based evidence is still scarce on safety of drugs during breastfeeding, risk assessment relies on the little clinical evidence available and on pharmacokinetic principles, as well as on specialized sources of information that are essential for clinical decision-making. Risk assessment should not only be based on the drug's potential risk for the breastfed infant but should always take into account the benefits associated to breastfeeding, the risks of untreated maternal disease and the maternal willingness to breastfeed. Identifying situations with potential for drug accumulation in the breastfed infant is decisive while assessing the risk. Health care providers should always assume that mothers will be concerned and use risk communication as a key to ensure medication adherence and prevent unnecessary interruption of breastfeeding. When a mother still expresses concerns, decision support algorithms may facilitate communication and some strategies can be offered to minimize the drug exposure in the breastfed infant even when clinically not justified.(c) 2023 Societe francaise de pharmacologie et de th ' erapeutique. Published by Elsevier Masson SAS. All rights reserved.

Automated summary

Human milk is the best nutrition for infants, and taking medication postpartum is common. Discontinuing breastfeeding is often wrongly advised due to concerns of adverse effects on the infant, even though only a few drugs are strictly prohibited while breastfeeding. Most drugs are transferred from the mother's blood to the milk, but the amount ingested by the infant is usually small. As there is limited population-based evidence on drug safety during breastfeeding, risk assessment relies on available clinical evidence, pharmacokinetic principles, and specialized sources of information for clinical decision-making. Risk assessment should consider both the potential risk to the infant and the benefits and risks associated with breastfeeding and maternal disease. Identifying situations with potential for drug accumulation in the infant is crucial for risk assessment. Healthcare providers should assume maternal concerns and utilize risk communication to ensure medication adherence without interrupting breastfeeding unnecessarily. Decision support algorithms and strategies can be used to minimize drug exposure in the breastfed infant, even when clinically not justified.