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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
Safety of using glucagon-like peptide-1 receptor drugs during pregnancy based on FDA side effect reports
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Abstract
An exponential rise in reported adverse drug reactions (ADRs) associated with GLP-1 receptor agonists (RAs) in pregnant women has been observed since 2012, with 354 cases and 1671 reports analyzed.
- Significant ADR signals were identified in the reproductive and gastrointestinal systems, with spontaneous abortion and pre-eclampsia as key concerns.
- The median age of affected women was 36 years, with over half classified as advanced age pregnant.
- Heightened risk of ADRs was noted across most age groups, particularly in women older than 24 years.
- No significant dose-related differences in ADRs were found, suggesting consistent risk regardless of dosage.
- GLP-1 RAs are not recommended for use during pregnancy, and close monitoring is advised in cases of unintentional exposure.
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