Antibiotics and lactation: An overview of relative infant doses and a systematic assessment of clinical studies

Basic Clin Pharmacol Toxicol. 2019 Jan;124(1):5-17. doi: 10.1111/bcpt.13098. Epub 2018 Sep 7.


Breastfeeding is important for the development of the child. Many antibiotics are considered safe during breastfeeding. The aim of the study was to assess the quality of lactation studies with antibiotics using the FDA and International Lactation Consultant Association quality guidelines for lactation studies. The secondary goal was to determine the exposure of the breastfed infant to antibiotics in relation to bacterial resistance and the developing microbiome. A literature search was performed and the included studies were scored on methodology, parameters concerning maternal exposure to antibiotics, maternal plasma and milk sampling. The infant exposure has been calculated and expressed as a percentage of a normal infant therapeutic dose. Sixty-six studies were included in five antibiotic groups (broad-spectrum penicillin, cephalosporins, macrolides and lincosamides, quinolones and sulphonamides). Cephalosporins were the most studied group of antibiotics (n = 21). Fifteen studies met all the criteria of "mother exposure to antibiotic". Six studies met every criterion related to "plasma sampling". Only one case report met all listed criteria for lactation studies. The correct calculation of infant exposure to antibiotics via the milk:plasma ratio (AUC) varies between 13% for macrolides and 38% for broad-spectrum penicillin. The highest assessed exposure as a percentage of infant therapeutic dose was for metronidazole (11%). The studies meet to a limited extent with the quality standards for lactation research. The breastfed infants are exposed to a subtherapeutic concentration of antibiotics.

Keywords: antibiotics; breastfeeding; infancy; microbiome.

Publication types

  • Review

MeSH terms

  • Anti-Bacterial Agents / adverse effects*
  • Breast Feeding*
  • Drug Resistance, Bacterial / drug effects*
  • Female
  • Gastrointestinal Microbiome / drug effects*
  • Humans
  • Infant
  • Maternal Exposure / adverse effects*
  • Milk, Human / chemistry


  • Anti-Bacterial Agents