| アブストラクト | 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. |
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| 投稿者 | McCall, Kenneth L; Mastro Dwyer, Keri A; Casey, Ryan T; Samana, Tasnia N; Sulicz, Ewa K; Tso, Susannah Y; Yalanzhi, Emma R; Piper, Brian J |
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| 組織名 | Department of Pharmacy Practice, School of Pharmacy and Pharmaceutical Sciences,;Binghamton University, Johnson City, NY, USA.;Department of Medical Education, Geisinger Commonwealth School of Medicine,;Scranton, PA, USA.;Center for Pharmacy Innovation and Outcomes, Geisinger, Danville, PA, USA. |
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