Safety analysis of compounded GLP-1 receptor agonists: a pharmacovigilance study using the FDA adverse event reporting system

Apr 26, 2025Expert opinion on drug safety

Safety of compounded GLP-1 receptor drugs based on FDA adverse event reports

AI simplified

GLP-1 Therapies on OpenScience ↗PubMed ↗DOI ↗

Abstract

Of the 81,078 GLP-1 RA reports in the FAERS database, 707 involved compounded products.

Compounded formulations showed higher odds of adverse events like abdominal pain (2.84), suicidality (6.34), and cholecystitis (3.39).
There were significantly higher odds of preparation errors (48.92) and contamination issues (19.00) in compounded products.
Compounded products had lower odds of administration (0.29) and dosing errors (0.24).
Hospitalization odds were higher for compounded products (2.35) compared to non-compounded versions.

AI simplified

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.

Full Text

Full text is available at the source.

View full text ↗

Safety analysis of compounded GLP-1 receptor agonists: a pharmacovigilance study using the FDA adverse event reporting system

Abstract

Full Text

You found one interesting study. We’ll send the next 7.

what lands in your inbox each week:

Recent issues from the glp-1 therapies brief

Abstract

Full Text

Related papers

You found one interesting study. We’ll send the next 7.

what lands in your inbox each week:

Recent issues from the glp-1 therapies brief