Gestational diabetes & diabetes in pregnancy
Glucagon‐like peptide 1 ( GLP ‐1) receptor agonists' use during pregnancy: Safety data from regulatory clinical trials
Authors' conclusion
Key knowledge gaps must be addressed before the introduction of the Glucagon-like peptide-1 receptor agonist class of drugs for pregnant women. Currently, Glucagon-like peptide-1 receptor agonists should be stopped as soon as the patient becomes aware of a pregnancy. The establishment of patient registries designed to capture data relating to cases of Glucagon-like peptide-1 receptor agonist exposure during pregnancy is a high priority, and where data already exist, the findings need to be published.
Study context
- Population
- Women with unplanned pregnancies during regulatory clinical trials of GLP-1 RA submitted to the FDA and EMA
- Outcome
- Outcomes of unplanned pregnancies during GLP-1 RA regulatory clinical trials
Methodological detailsFDA and EMA regulatory documents, FDA CDER Clinical and Medical Reviews before market authorisation
- FDA and EMA regulatory documents
- FDA CDER Clinical and Medical Reviews before market authorisation
Main finding
As reported in the abstract
Congenital abnormalities after GLP-1 RA use during pregnancy
- Incidence of congenital abnormalities in humans appears relatively low after GLP-1 RA use during pregnancy
- No evidence in planned pregnancies; only evidence is from pregnancies occurring inadvertently during GLP-1 RA trials
Original publication
Glucagon‐like peptide 1 ( GLP ‐1) receptor agonists' use during pregnancy: Safety data from regulatory clinical trials. Diabetes Obes Metab. Published 6 May 2025. doi:10. 1111/ dom. 16437
Composed by AI from the published abstract and checked against it. How Briefs are made →