The safety profile of usage of glucagon-like peptide-1 receptor agonists in pregnancy: A pharmacovigilance analysis based on the Food and Drug Administration Adverse Event Reporting System.

Abstract

Aims: The use of (GLP-1 RAs) among pregnant women is escalating, yet safety data remain insufficient. This study aims to comprehensively assess adverse drug reactions (ADRs) associated with GLP-1 RAs in pregnant women using the US Food and Drug Administration Adverse Event Reporting System (FAERS) database.

Methods: FAERS data from 2004 to 2023 were analysed, focusing on pregnant women aged 15-55 years exposed to GLP-1 RAs. Descriptive analysis covered patient demographics, clinical aspects and annual trends. Disproportionality analysis used reporting odds ratio and Bayesian confidence propagation neural network to detect ADR signals.

Results: Among 354 cases with 1671 ADR reports, an exponential rise in reported cases since 2012 was observed. The median age of the affected women was 36 years, with 50.56% classified as advanced age pregnant. The disproportionality analysis revealed significant ADR signals in the reproductive (n = 199) and gastrointestinal systems (n = 155), with spontaneous abortion and pre-eclampsia being the most concerning. Additionally, while no significant dose-related differences were found, the age subgroup analysis indicated heightened risk across most age groups, except for those aged 20-24 years, highlighting the need for careful monitoring of GLP-1 RAs used during pregnancy.

Conclusion: This study highlights increasing GLP-1 RA use in pregnant women and identifies potential pregnant ADRs. GLP-1 RAs are not recommended for use during pregnancy. In cases of unintentional exposure, close monitoring is advised to ensure maternal and foetal safety. These findings provide valuable insights for clinicians making informed decisions and regulators considering using GLP-1 RA in pregnancy.