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

Overview

Journal Endocrine

Specialty Endocrinology

Date 2024 Nov 22

PMID 39578328

Authors

Jianxing Zhou

Wei Huang

Yunzhen Xie

Haobin Shen

Maobai Liu

Xuemei Wu

Affiliations

Soon will be listed here.

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.

References

Targher G, Mantovani A, Byrne C . Mechanisms and possible hepatoprotective effects of glucagon-like peptide-1 receptor agonists and other incretin receptor agonists in non-alcoholic fatty liver disease. Lancet Gastroenterol Hepatol. 2023; 8(2):179-191. DOI: 10.1016/S2468-1253(22)00338-7. View

Drucker D, Holst J . The expanding incretin universe: from basic biology to clinical translation. Diabetologia. 2023; 66(10):1765-1779. DOI: 10.1007/s00125-023-05906-7. View

Colhoun H, Lingvay I, Brown P, Deanfield J, Brown-Frandsen K, Kahn S . Long-term kidney outcomes of semaglutide in obesity and cardiovascular disease in the SELECT trial. Nat Med. 2024; 30(7):2058-2066. PMC: 11271413. DOI: 10.1038/s41591-024-03015-5. View

Lingvay I, Deanfield J, Kahn S, Weeke P, Toplak H, Scirica B . Semaglutide and Cardiovascular Outcomes by Baseline HbA1c and Change in HbA1c in People With Overweight or Obesity but Without Diabetes in SELECT. Diabetes Care. 2024; 47(8):1360-1369. PMC: 11282385. DOI: 10.2337/dc24-0764. View

ONeil P, Birkenfeld A, McGowan B, Mosenzon O, Pedersen S, Wharton S . Efficacy and safety of semaglutide compared with liraglutide and placebo for weight loss in patients with obesity: a randomised, double-blind, placebo and active controlled, dose-ranging, phase 2 trial. Lancet. 2018; 392(10148):637-649. DOI: 10.1016/S0140-6736(18)31773-2. View

Tan B, Pan X, Chew H, Goh R, Lin C, Anand V . Efficacy and safety of tirzepatide for treatment of overweight or obesity. A systematic review and meta-analysis. Int J Obes (Lond). 2023; 47(8):677-685. DOI: 10.1038/s41366-023-01321-5. View

Moll H, Frey E, Gerber P, Geidl B, Kaufmann M, Braun J . GLP-1 receptor agonists for weight reduction in people living with obesity but without diabetes: a living benefit-harm modelling study. EClinicalMedicine. 2024; 73:102661. PMC: 11154119. DOI: 10.1016/j.eclinm.2024.102661. View

He L, Wang J, Ping F, Yang N, Huang J, Li Y . Association of Glucagon-Like Peptide-1 Receptor Agonist Use With Risk of Gallbladder and Biliary Diseases: A Systematic Review and Meta-analysis of Randomized Clinical Trials. JAMA Intern Med. 2022; 182(5):513-519. PMC: 8961394. DOI: 10.1001/jamainternmed.2022.0338. View

Kapoor I, Sarvepalli S, DAlessio D, Grewal D, Hadziahmetovic M . GLP-1 receptor agonists and diabetic retinopathy: A meta-analysis of randomized clinical trials. Surv Ophthalmol. 2023; 68(6):1071-1083. DOI: 10.1016/j.survophthal.2023.07.002. View

10.

Zheng D, Li N, Hou R, Zhang X, Wu L, Sundquist J . Glucagon-like peptide-1 receptor agonists and diabetic retinopathy: nationwide cohort and Mendelian randomization studies. BMC Med. 2023; 21(1):40. PMC: 9898966. DOI: 10.1186/s12916-023-02753-6. View

11.

Browning D, Stewart M, Lee C . Diabetic macular edema: Evidence-based management. Indian J Ophthalmol. 2018; 66(12):1736-1750. PMC: 6256891. DOI: 10.4103/ijo.IJO_1240_18. View

12.

Hathaway J, Shah M, Hathaway D, Zekavat S, Krasniqi D, Gittinger Jr J . Risk of Nonarteritic Anterior Ischemic Optic Neuropathy in Patients Prescribed Semaglutide. JAMA Ophthalmol. 2024; 142(8):732-739. PMC: 11223051. DOI: 10.1001/jamaophthalmol.2024.2296. View

13.

Zhou J, Zheng Y, Xu B, Long S, Zhu L, Liu Y . Exploration of the potential association between GLP-1 receptor agonists and suicidal or self-injurious behaviors: a pharmacovigilance study based on the FDA Adverse Event Reporting System database. BMC Med. 2024; 22(1):65. PMC: 10865629. DOI: 10.1186/s12916-024-03274-6. View

14.

Ren W, Wang W, Guo Y . Analysis of Adverse Reactions of Aspirin in Prophylaxis Medication Based on FAERS Database. Comput Math Methods Med. 2022; 2022:7882277. PMC: 9162824. DOI: 10.1155/2022/7882277. View

15.

Yu R, Krantz M, Phillips E, Stone Jr C . Emerging Causes of Drug-Induced Anaphylaxis: A Review of Anaphylaxis-Associated Reports in the FDA Adverse Event Reporting System (FAERS). J Allergy Clin Immunol Pract. 2020; 9(2):819-829.e2. PMC: 7870524. DOI: 10.1016/j.jaip.2020.09.021. View

16.

Liu L, Chen J, Wang L, Chen C, Chen L . Association between different GLP-1 receptor agonists and gastrointestinal adverse reactions: A real-world disproportionality study based on FDA adverse event reporting system database. Front Endocrinol (Lausanne). 2022; 13:1043789. PMC: 9770009. DOI: 10.3389/fendo.2022.1043789. View

17.

Melles R, Jorge A, Marmor M, Zhou B, Conell C, Niu J . Hydroxychloroquine Dose and Risk for Incident Retinopathy : A Cohort Study. Ann Intern Med. 2023; 176(2):166-173. DOI: 10.7326/M22-2453. View

18.

van Puijenbroek E, Bate A, Leufkens H, Lindquist M, Orre R, Egberts A . A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions. Pharmacoepidemiol Drug Saf. 2002; 11(1):3-10. DOI: 10.1002/pds.668. View

19.

Noren G, Hopstadius J, Bate A . Shrinkage observed-to-expected ratios for robust and transparent large-scale pattern discovery. Stat Methods Med Res. 2011; 22(1):57-69. PMC: 6331976. DOI: 10.1177/0962280211403604. View

20.

Noguchi Y, Tachi T, Teramachi H . Comparison of Signal Detection Algorithms Based on Frequency Statistical Model for Drug-Drug Interaction Using Spontaneous Reporting Systems. Pharm Res. 2020; 37(5):86. DOI: 10.1007/s11095-020-02801-3. View