Late Pregnancy Azithromycin Use Linked to Lower Risk of Neurodevelopmental Disorders in Children: JAMA
USA: A recent study published in JAMA Network Open has explored the potential link between prenatal exposure to azithromycin and the risk of neurodevelopmental disorders (NDDs) in children, offering some reassuring yet cautious insights for clinicians and expectant mothers.
The research, led by Marianne N. Otoo from the Department of Pharmacy Practice & Clinical Research at the University of Rhode Island, aimed to clarify ongoing uncertainty regarding the neurodevelopmental safety of azithromycin use during pregnancy. Azithromycin is widely prescribed to treat bacterial infections in pregnant women, but its long-term effects on child neurodevelopment have remained unclear.
For this purpose, the researchers conducted a large retrospective cohort study using administrative health claims data spanning from January 2012 to October 2024. The analysis included 15,527 mother-infant pairs, with mothers aged between 12 and 55 years who had a live birth between December 2012 and December 2023. Participants were categorized based on antibiotic exposure during pregnancy: 742 pregnancies involved azithromycin, 3,079 involved other antibiotics, and 11,706 had no antibiotic exposure.
The investigators applied propensity score matching and Cox proportional hazards models to assess the incidence of various NDDs during a mean follow-up period of 5.5 years. The outcomes evaluated included attention-deficit/hyperactivity disorder, autism spectrum disorder, speech and language disorders (SLD), developmental coordination disorder, and behavioral disorders.
The study led to the following findings:
- Late pregnancy exposure to azithromycin was associated with a lower risk of certain neurodevelopmental outcomes compared to other antibiotic classes.
- Children exposed to azithromycin in late gestation showed a reduced risk of overall neurodevelopmental disorders (NDDs) compared to those exposed to other antibiotics.
- A lower risk of speech and language disorders (SLD) was observed in children exposed to azithromycin compared to both other antibiotics and no antibiotic exposure.
- No statistically significant difference was found in overall NDD risk when comparing azithromycin exposure with no antibiotic use.
- The findings indicate that azithromycin use in late pregnancy may not increase the risk of neurodevelopmental disorders and may be linked to a lower risk compared to other antibiotics.
- The authors advise cautious interpretation of these results.
The study has some limitations. Residual confounding from unmeasured factors such as maternal diet, infection severity, and socioeconomic status cannot be ruled out. Prescription data may not reflect actual drug intake, and genetic or familial factors were not accounted for. Additionally, the commercially insured study population may limit the generalizability of the findings.
The authors conclude that while late pregnancy exposure to azithromycin appears to be associated with a lower risk of NDDs—particularly speech and language disorders—clinical decisions should continue to follow established guidelines. Currently, β-lactam antibiotics remain the preferred first-line treatment during pregnancy. Further large-scale studies involving more diverse populations are needed to validate these observations and guide clinical practice.
Reference:
Otoo MN, Meador KJ, Brothers T, et al. Prenatal Azithromycin Exposure and Risk of Neurodevelopmental Disorders in Children. JAMA Netw Open. 2026;9(5):e2612051. doi:10.1001/jamanetworkopen.2026.12051
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