Impact of semaglutide exposure on fetal and neonatal outcomes in pregnant women: a systematic review.
Mandal. Laura L; Andersen. Louise Udby LU; Luef. Birgitte Møller BM; Tanvig. Mette Honnens MH; Vinter. Christina Anne CA
Key Findings
- Mixed pregnancy outcomes: some studies reported miscarriage, pre‑eclampsia, and macrosomia after stopping the drug
- No clear increase in major congenital malformations compared to insulin or other groups
- Evidence is limited and heterogeneous, making firm safety conclusions difficult
Practical Outcomes
- Women of child‑bearing age should avoid starting semaglutide if they plan to get pregnant and discuss stopping it before conception with a healthcare provider. If exposure occurs, close monitoring of pregnancy and newborn health is advised, but current data do not show a strong link to birth defects.
Summary
The review looked at 5 studies with over a thousand pregnancies where the mother had taken semaglutide, a drug used for weight loss and diabetes. The results were mixed – some reports of miscarriage and pre‑eclampsia, a few birth defects but not more than with insulin, and some babies being larger than normal if the drug was stopped early. Overall, there’s no solid proof that semaglutide causes major birth defects, but the data are limited and not consistent.
Abstract
Semaglutide, a glucagon-like peptide-1 receptor agonist, is increasingly used for obesity and type 2 diabetes treatment. As its use rises among women of reproductive age, understanding its impact on fetal and neonatal health is essential. To assess fetal and neonatal outcomes associated with semaglutide exposure during pregnancy or within two months before conception. PubMed, Embase, and ClinicalTrials.gov were searched for relevant studies. Studies reporting fetal and neonatal outcomes following semaglutide exposure before or during pregnancy were included, with no language restrictions. Two reviewers independently screened and extracted data. Due to study heterogeneity, a narrative synthesis was used, and bias risk and study quality were assessed. Five studies involving a total of 1,128 semaglutide exposed pregnancies, showed mixed results. One study reported adverse outcomes including spontaneous abortion and preeclampsia. Another study found spontaneous abortion rate of 23%, comparable to diabetes- and obesity-groups. A third study observed a prevalence of congenital malformations of 8.3%, with no significant risk increase compared to insulin. One study linked semaglutide discontinuation to fetal macrosomia and neonatal hypoglycaemia. Another noted preterm birth and large-for-gestational-age infants, with no increased congenital malformation risk. No clear association with birth defects was identified, however the evidence is limited by study variability and bias risk. The limited number of available studies precludes firm conclusions nevertheless current evidence does not indicate a consistent increased risk of major congenital malformations associated with semaglutide exposure.
Study Information
pubmed
2025
2025-11-21T00:00:00.000Z
10.1016/j.ejogrb.2025.114836
28