Pharmacovigilance of drug-induced cataract using the FDA Adverse Event Reporting System
Abstract Cataract is a leading cause of irreversible vision loss, particularly among the elderly, with drug-induced cataract being an underrecognized yet significant contributor to visual impairment. This study investigates the associations between medications and cataract development using real-wor...
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Nature Portfolio
2025-07-01
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| Series: | Scientific Reports |
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| Online Access: | https://doi.org/10.1038/s41598-025-10924-z |
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| author | Si-Yuan Hong Wen-Rui Lu Xiao-Dong Chen Hui-Ying Rao Han Chen |
| author_facet | Si-Yuan Hong Wen-Rui Lu Xiao-Dong Chen Hui-Ying Rao Han Chen |
| author_sort | Si-Yuan Hong |
| collection | DOAJ |
| description | Abstract Cataract is a leading cause of irreversible vision loss, particularly among the elderly, with drug-induced cataract being an underrecognized yet significant contributor to visual impairment. This study investigates the associations between medications and cataract development using real-world data from the FDA Adverse Event Reporting System (FAERS) from Q1 2004 to Q3 2024. A total of 54,800 reports were analyzed, including 2,336 cases involving 691 drugs in individuals aged 0–45 years. Disproportionality analysis identified 24 drugs significantly associated with cataract risk, with the highest risks linked to glucocorticoids (e.g., fluticasone furoate, triamcinolone), insulin analogs (e.g., insulin glargine, insulin human), and other agents like nitisinone and ranibizumab. Difluprednate showed the strongest association (Bayesian Confidence Propagation Neural Network [BCPNN] = 7.83), followed by prednisolone (BCPNN = 6.84) and erdafitinib (BCPNN = 5.44). Difluprednate had the shortest median onset time (74 days), while prednisolone’s median onset was 141 days. Antineoplastic agents demonstrated the fastest average onset of cataracts (533.89 days). The majority of cases were reported in females (57.9%), with a noticeable annual increase in cases. This study provides a comprehensive pharmacovigilance evaluation, offering insights into high-risk medications, their onset patterns, and demographic trends, contributing to improved clinical decision-making and cataract prevention strategies. |
| format | Article |
| id | doaj-art-e8892ee6626b4a76a03bb601f7c554ec |
| institution | DOAJ |
| issn | 2045-2322 |
| language | English |
| publishDate | 2025-07-01 |
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| spelling | doaj-art-e8892ee6626b4a76a03bb601f7c554ec2025-08-20T03:05:22ZengNature PortfolioScientific Reports2045-23222025-07-0115111410.1038/s41598-025-10924-zPharmacovigilance of drug-induced cataract using the FDA Adverse Event Reporting SystemSi-Yuan Hong0Wen-Rui Lu1Xiao-Dong Chen2Hui-Ying Rao3Han Chen4Department of Ophthalmology, Provincial Clinical School of Fujian Medical UniversityDepartment of Ophthalmology, Provincial Clinical School of Fujian Medical UniversitySchool of Medicine, Eye Institute of Xiamen University, Xiamen UniversityDepartment of Ophthalmology, Provincial Clinical School of Fujian Medical UniversityDepartment of Ophthalmology, Provincial Clinical School of Fujian Medical UniversityAbstract Cataract is a leading cause of irreversible vision loss, particularly among the elderly, with drug-induced cataract being an underrecognized yet significant contributor to visual impairment. This study investigates the associations between medications and cataract development using real-world data from the FDA Adverse Event Reporting System (FAERS) from Q1 2004 to Q3 2024. A total of 54,800 reports were analyzed, including 2,336 cases involving 691 drugs in individuals aged 0–45 years. Disproportionality analysis identified 24 drugs significantly associated with cataract risk, with the highest risks linked to glucocorticoids (e.g., fluticasone furoate, triamcinolone), insulin analogs (e.g., insulin glargine, insulin human), and other agents like nitisinone and ranibizumab. Difluprednate showed the strongest association (Bayesian Confidence Propagation Neural Network [BCPNN] = 7.83), followed by prednisolone (BCPNN = 6.84) and erdafitinib (BCPNN = 5.44). Difluprednate had the shortest median onset time (74 days), while prednisolone’s median onset was 141 days. Antineoplastic agents demonstrated the fastest average onset of cataracts (533.89 days). The majority of cases were reported in females (57.9%), with a noticeable annual increase in cases. This study provides a comprehensive pharmacovigilance evaluation, offering insights into high-risk medications, their onset patterns, and demographic trends, contributing to improved clinical decision-making and cataract prevention strategies.https://doi.org/10.1038/s41598-025-10924-zCataractFAERSRisk of drug-induced cataractMedicationDisproportionality analysis |
| spellingShingle | Si-Yuan Hong Wen-Rui Lu Xiao-Dong Chen Hui-Ying Rao Han Chen Pharmacovigilance of drug-induced cataract using the FDA Adverse Event Reporting System Scientific Reports Cataract FAERS Risk of drug-induced cataract Medication Disproportionality analysis |
| title | Pharmacovigilance of drug-induced cataract using the FDA Adverse Event Reporting System |
| title_full | Pharmacovigilance of drug-induced cataract using the FDA Adverse Event Reporting System |
| title_fullStr | Pharmacovigilance of drug-induced cataract using the FDA Adverse Event Reporting System |
| title_full_unstemmed | Pharmacovigilance of drug-induced cataract using the FDA Adverse Event Reporting System |
| title_short | Pharmacovigilance of drug-induced cataract using the FDA Adverse Event Reporting System |
| title_sort | pharmacovigilance of drug induced cataract using the fda adverse event reporting system |
| topic | Cataract FAERS Risk of drug-induced cataract Medication Disproportionality analysis |
| url | https://doi.org/10.1038/s41598-025-10924-z |
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