Pregnancy exposure to GLP-1 and dual GLP-1/GIP receptor agonists shows no consistent increase in malformationsData shows no clear risk for babies and mothers using GLP-1

BackgroundTo evaluate maternal, fetal, and neonatal outcomes after preconception or gestational exposure to glucagon-like peptide-1 receptor agonists and dual glucagon-like peptide-1/glucose-dependent insulinotropic polypeptide receptor agonists, and to assess the reproducibility of reported safety signals.MethodsSix databases plus a drug-level safety search were searched through 16 July 2026. Exposure was classified into four clinically defined time windows. Independent studies or data sources were the analytic unit; one primary comparator was selected per study, and odds ratios and risk ratios were synthesized separately. Random-effects meta-analysis, timing-stratified and dominant-study sensitivity analyses, Newcastle-Ottawa Scale assessment, and GRADE certainty assessment were used.ResultsFourteen comparative data sources were included; 13 were quantitatively eligible and eight contributed to at least one pooled estimate. In the timing-specific analysis of major congenital malformations, four studies with verified periconceptional/first-trimester exposure yielded an odds ratio of 0.99 (95% confidence interval 0.77–1.27). A secondary pregnancy-period analysis that added one unadjusted, trimester-unspecified cohort yielded 1.00 (0.94–1.06); that cohort contributed 93.5% of the weight. Pooled preterm birth, small-for-gestational-age birth, and stillbirth analyses showed no statistically significant differences. Preeclampsia and other sparse outcomes were not pooled. Certainty was very low for all key outcomes.ConclusionCurrent evidence does not demonstrate a clear or consistent increase in major congenital malformation risk, but very low certainty, imprecision, residual confounding, heterogeneous comparators, sparse agent-specific data, and uncertain exposure timing preclude conclusions of safety. Reported preeclampsia and renal or urinary signals have not been independently replicated.