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ObjectivesGlucagon-like peptide 1 receptor agonists (GLP1-RA) are indicated for the treatment of type 2 diabetes and more recently for weight loss. The aim of this study was to assess the risks associated with GLP1-RA exposure during early pregnancy.DesignThis multicentre, observational prospective cohort study compared pregnancy outcomes in women exposed to GLP1-RA in early pregnancy either for diabetes or obesity treatment with those in two reference groups: (1) women with diabetes exposed to at least one non-GLP1-RA antidiabetic drug during the first trimester and (2) a reference group of overweight/obese women without diabetes, between 2009 and 2022.SettingData were collected from the databases of six Teratology Information Services.ParticipantsThis study included 168 pregnancies of women exposed to GLP1-RA during the first trimester, alongside a reference group of 156 pregnancies of women with diabetes and 163 pregnancies of overweight/obese women.ResultsExposure to GLP1-RA in the first trimester was not associated with a risk of major birth defects when compared with diabetes (2.6% vs 2.3%; adjusted OR, 0.98 (95% CI, 0.16 to 5.82)) or to overweight/obese (2.6% vs 3.9%; adjusted OR 0.54 (0.11 to 2.75)). For the GLP1-RA group, cumulative incidence for live births, pregnancy losses and pregnancy terminations was 59%, 23% and 18%, respectively. In the diabetes reference group, corresponding estimates were 69%, 26% and 6%, while in the overweight/obese reference group, they were 63%, 29% and 8%, respectively. Cox proportional cause-specific hazard models indicated no increased risk of pregnancy losses in the GLP1-RA versus the diabetes and the overweight/obese reference groups, in both crude and adjusted analyses.ConclusionsThis study offers reassurance in cases of inadvertent exposure to GLP1-RA during the first trimester of pregnancy. Due to the limited sample size, larger studies are required to validate these findings.

Background: Bilastine is a long-acting, nonsedating antihistamine used to treat allergic conditions. Human pregnancy experience with bilastine remains limited. Objectives: The primary aim was to evaluate the risk of major anomalies following first-trimester bilastine exposure. Secondary endpoints included additional pregnancy outcomes. Methods: This observational, prospective cohort study included women counseled by the Israeli Teratology Information Service regarding first-trimester bilastine exposure between July 2019 and June 2023. Participants were contacted by telephone for follow-up using a structured questionnaire. Pregnancy outcomes were compared with fexofenadine-exposed pregnancies. The data analysis, comparison, and presentation followed the recommendations of the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guide. Results: Follow-up was obtained for 36 pregnancies with at least first-trimester bilastine exposure. The median daily bilastine dose was 20 mg, with treatment discontinued at a median gestational age of 5 + 6 weeks. First-trimester bilastine exposure was not associated with an increased risk of major anomalies [bilastine: 2/33, 6.1% vs. fexofenadine: 2/27, 7.4%; crude OR 0.81, 95% CI 0.11–6.14]. No pattern of malformations was observed. Rates of live-birth, miscarriage, and pregnancy termination were 91.7%, 5.6%, and 2.8% in the bilastine group, and 72.2%, 19.4%, and 8.3% in the fexofenadine group, respectively. Conclusions: This cohort study, although small, provides preliminary reassurance for counseling regarding inadvertent early pregnancy exposure to bilastine. Larger studies are needed to validate these findings.