Safety analysis of compounded GLP-1 receptor agonists: a pharmacovigilance study using the FDA adverse event reporting system
- PMID: 40285721
- DOI: 10.1080/14740338.2025.2499670
Safety analysis of compounded GLP-1 receptor agonists: a pharmacovigilance study using the FDA adverse event reporting system
Abstract
Background: This study evaluated the safety of compounded glucagon-like peptide-1 receptor agonists (GLP-1 RAs) compared to non-compounded formulations using the U.S. FDA Adverse Event Reporting System (FAERS).
Research design and methods: A retrospective analysis of FAERS from 2018 to 2024 examined adverse events (AEs), medication errors, and product quality issues for liraglutide, semaglutide, and tirzepatide. Reporting odds ratios (RORs) with 95% confidence intervals were calculated with adjustment using logistic regression.
Results: Of the 81,078 GLP-1 RA reports in the FAERS database, 707 involved compounded products. Compounded formulations demonstrated higher RORs for abdominal pain (2.84 [2.29, 3.49]), diarrhea (1.59 [1.25, 1.99]), nausea (1.27 [1.05, 1.52]), suicidality (6.34, [4.32, 8.99]), and cholecystitis (3.39, [1.61, 6.31]). Compounded products showed higher RORs of preparation errors (48.92 [12.63, 189.6]), prescribing errors (4.46, [2.49, 7.98]), contamination (19.00, [4.24, 85.03]), and compounding/manufacturing issues (8.51, [5.17, 14.0]), while lower odds of administration (0.29 [0.16, 0.53]) and dosing errors (0.24, [0.17, 0.32]). The hospitalization odds were higher for compounded products (2.35 [1.94, 2.83]).
Conclusions: Compounded GLP-1 RAs may be associated with a higher odds of AEs, safety concerns, and product quality issues compared to non-compounded products. These findings underscore the importance of cautious prescribing, rigorous quality standards, and enhanced patient monitoring.
Keywords: Glucagon-like peptide-1 receptor agonists; adverse events; compounded medications; medication errors; pharmacovigilance; product quality.
Plain language summary
The study examined safety reports of compounded glucagon-like peptide-1 receptor agonists (GLP-1 RAs) compared to FDA-approved products. GLP-1 RAs are medications used to treat conditions like diabetes and obesity. Compounded drugs are not subject to the same rigorous safety and efficacy testing as FDA-approved drugs. Researchers analyzed reports from the FDA’s Adverse Event Reporting System from 2018 to 2024. The findings revealed that compounded GLP-1 RAs had a higher likelihood of reporting adverse effects like abdominal pain, nausea, diarrhea, gallbladder inflammation, and suicidality compared to standard formulations. Reporting of prescribing and preparation errors were higher for compounded medications. Hospitalization associated with adverse effects was reported more frequently in the compounded group. The results highlight the potential risks associated with compounded GLP-1 RAs, including variability in quality and dosing, which may contribute to errors and adverse events. The study recommends continued monitoring and enforcement of quality standards for compounded medications, as well as patient education regarding the potential risks. Healthcare providers should monitor patients closely and weigh the risks when prescribing these alternatives, especially amid shortages of FDA-approved GLP-1 RAs. These results must be interpreted cautiously as the study was not designed to show a cause-and-effect relationship. Further research is needed.
LinkOut - more resources
Full Text Sources
