Increased reporting of accidental overdose with glucagon-like peptide-1 receptor agonists: a population-based study

Abstract

ABSTRACT Background The use of online and/or compounding pharmacies to access glucagon-like peptide-1 receptor agonists (GLP-1 RAs) increases the risk for prescription error (e.g. accidental overdose) especially in racial, ethnic and socioeconomic disadvantaged groups. Methods We sought to evaluate accidental overdose associated with GLP-1 RAs submitted to the United States FDA Adverse Event Reporting System (FAERS). Case reports of accidental overdose reported to the FAERS were retrieved from Q4 2003 to Q1 2024 using OpenVigil 2.1. Disproportionality of accidental overdose was assessed using reporting odds ratio (ROR). Upper and lower 95% confidence intervals (CI) were calculated at an alpha level of 5%, where disproportionate reporting was considered when the lower 95% CI was greater than 1.0. Results We identified 3,348 reports of accidental overdose associated with GLP-1 RAs. The RORs were significant for all agents within the class (ROR range: 2.64–61.12, all p < 0.008), including semaglutide, dulaglutide, exenatide, liraglutide, and tirzepatide compared to niacin. Conclusions Inadequate access, availability, and affordability of GLP-1 RAs has contributed to the increased seeking via online and/or compounding pharmacies, and is associated with greater risk for prescription errors that differentially affect racial, ethnic and socioeconomic vulnerable populations. Pharmacovigilance database analyses cannot establish causation only association.