ORIGINAL RESEARCH article
Front. Pharmacol.
Sec. Pharmacoepidemiology
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1498191
This article is part of the Research TopicAdvances in Drug-induced Diseases Volume IIView all 45 articles
Real-World Pharmacovigilance Analysis of Drug-Related Cataracts Using the FDA Adverse Event Reporting System Database
Provisionally accepted
- 1Eye Center, Xiamen University, Xiamen, China
- 2Chongqing Three Gorges Medical College, Chongqing, China
- 3Fujian Provincial Key Laboratory of Ophthalmology and Visual Science, College of Medicine, Xiamen University, Xiamen, Fujian Province, China
- 4Kunming Medical University, Kunming, Yunnan Province, China
- 5Department of Pharmacy, Shanghai Pudong Hospital, Shanghai, Shanghai Municipality, China
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Objective: Although numerous drugs have been associated with cataracts, the risk for most drugs remains unclear. This study aimed to investigate the risk factors for drug-induced cataracts by analyzing large-scale data from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS).Methods: We used the reporting odds ratio (ROR) to evaluate reports of drug-induced cataracts in FAERS from the first quarter of 2004 to the third quarter of 2024. A univariate analysis, LASSO (least absolute shrinkage and selection operator) regression, and a multivariate regression analysis were performed to identify drug-related risk factors for cataracts, and Bonferroni correction was applied for multiple comparisons.Results: Multivariate logistic regression ultimately identified 15 drugs as independent risk factors, including immunomodulators (6/15), antineoplastic drugs (3/15), psychotropic drugs (1/15), respiratory drugs (1/15), gastrointestinal drugs (1/15), orthopedic drugs (1/15), metabolic regulators (1/15), and ophthalmic drugs (1/15). The median time to onset of drug-induced cataracts was 449 days (interquartile range [IQR]: 150–901 days), with approximately 75% of adverse events occurring within 747 days.Conclusion: These findings may help clinicians detect drug-related cataracts at an early stage and provide valuable insights for future research on the mechanisms of drug-induced cataracts.
Keywords: FAERS, Cataracts, drug, Cataract prevention, Adverse event
Received: 18 Sep 2024; Accepted: 08 Apr 2025.
Copyright: © 2025 Li, Wang, Zhang, Jiafeng, Tao and Luo. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Xiang Li, Eye Center, Xiamen University, Xiamen, China
Tang Jiafeng, Chongqing Three Gorges Medical College, Chongqing, 404120, China
Tao Tao, Chongqing Three Gorges Medical College, Chongqing, 404120, China
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.