Risk of ophthalmic adverse drug reactions in patients prescribed glucagon-like peptide 1 receptor agonists: a pharmacovigilance study based on the FDA adverse event reporting system database

Jianxing Zhou; Wei Huang; Yunzhen Xie; Haobin Shen; Maobai Liu; Xuemei Wu

doi:10.1007/s12020-024-04112-8

Risk of ophthalmic adverse drug reactions in patients prescribed glucagon-like peptide 1 receptor agonists: a pharmacovigilance study based on the FDA adverse event reporting system database

Endocrine. 2024 Nov 22. doi: 10.1007/s12020-024-04112-8. Online ahead of print.

Authors

Jianxing Zhou¹, Wei Huang¹, Yunzhen Xie², Haobin Shen³, Maobai Liu¹, Xuemei Wu⁴

Affiliations

¹ Department of Pharmacy, Fujian Medical University Union Hospital, Fuzhou, Fujian, China.
² Department of Pharmacy, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou, China.
³ School of Basic Medicine and Clinical Pharmacy, China Pharmaceutical University, Nanjing, Jiangsu, China.
⁴ Department of Pharmacy, Fujian Medical University Union Hospital, Fuzhou, Fujian, China. wuxuemei@fjmu.edu.cn.

PMID: 39578328
DOI: 10.1007/s12020-024-04112-8

Abstract

Objective: To investigate the association between glucagon-like peptide 1 receptor agonists (GLP-1 RAs) and ophthalmic adverse drug reactions (OADRs) using data from the FDA Adverse Event Reporting System (FAERS).

Methods: This retrospective pharmacovigilance study analyzed post-marketing FAERS data from 2018 to 2023 to identify GLP-1 RA-related OADRs. This study employed the Weibull model for time-to-onset (TTO) analysis, Bayesian Information Component analysis for disproportionality comparing GLP-1 RAs with other drugs, and the Ω shrinkage method for co-medication analysis.

Results: FAERS reported 5003 OADRs associated with GLP-1 RAs, including retinopathy and visual impairment. Disproportionality analysis identified significant signals for semaglutide, liraglutide, and exenatide, suggesting potential associations with OADRs. Co-medication analysis indicated that OADRs primarily resulted from GLP-1 RA use. TTO analysis categorized most OADRs as early failures, emphasizing the need for early monitoring.

Conclusion: This study emphasizes the importance of ophthalmic surveillance in patients using GLP-1 RAs, particularly semaglutide, dulaglutide, and exenatide. Enhanced monitoring and patient education are essential for timely detection and management of potential OADRs. Regulatory agencies should consider updating drug labels to include comprehensive warnings about OADRs associated with GLP-1 RA therapies.

Keywords: FAERS database; GLP-1RAs; Obesity; Ophthalmic Adverse Drug Reactions; Pharmacovigilance; Type 2 diabetes.