Real world pharmacovigilance assessment of drug related macular degeneration risks

Abstract Macular degeneration is a leading cause of irreversible vision loss, significantly impacting quality of life. To enhance clinical practice and reduce the risk of drug-related macular degeneration, we analyzed drug-related trends using real-world data. Disproportionality analysis of adverse...

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Main Authors: Xiaodong Chen, Shinan Wu, Shaopan Wang, Chaofeng Yu, Zihan Guo, Shiya Huang, Peixin Cai, Yanliang Miao, Shiying Li, Qian Chen
Format: Article
Language:English
Published: Nature Portfolio 2025-01-01
Series:Scientific Reports
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Online Access:https://doi.org/10.1038/s41598-024-84679-4
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author Xiaodong Chen
Shinan Wu
Shaopan Wang
Chaofeng Yu
Zihan Guo
Shiya Huang
Peixin Cai
Yanliang Miao
Shiying Li
Qian Chen
author_facet Xiaodong Chen
Shinan Wu
Shaopan Wang
Chaofeng Yu
Zihan Guo
Shiya Huang
Peixin Cai
Yanliang Miao
Shiying Li
Qian Chen
author_sort Xiaodong Chen
collection DOAJ
description Abstract Macular degeneration is a leading cause of irreversible vision loss, significantly impacting quality of life. To enhance clinical practice and reduce the risk of drug-related macular degeneration, we analyzed drug-related trends using real-world data. Disproportionality analysis of adverse event reports from the FDA Adverse Event Reporting System (FAERS, 2004–2023) identified 67,683 cases involving 1402 drugs. Among these, 42 drugs were linked to significant risks, including treatments for breast cancer (tamoxifen, raloxifene, anastrozole, letrozole) and diabetes (insulin lispro, insulin human). The BCPNN algorithm revealed that 45.2% (19/42) of these drugs had the strongest associations with macular degeneration, with pentosan polysulfate sodium, travoprost, and tolterodine being the highest-risk drugs. Lifitegrast, nicotine, and travoprost were associated with the shortest onset times for ocular adverse events. Among drug classes, glucocorticosteroids were linked to the most rapid onset of ocular side effects (P < 0.001), typically occurring within two months compared to other drugs. Drug-related macular degeneration was more common in women (70.4%) and predominantly affected those aged 60–80. The incidence of drug-related macular degeneration has steadily increased in recent years. This study offers valuable pharmacovigilance insights, highlighting drugs and demographic factors linked to macular degeneration.
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spelling doaj-art-c328781b2b0f4a759f62fd9685cc7e0c2025-01-12T12:24:28ZengNature PortfolioScientific Reports2045-23222025-01-0115111610.1038/s41598-024-84679-4Real world pharmacovigilance assessment of drug related macular degeneration risksXiaodong Chen0Shinan Wu1Shaopan Wang2Chaofeng Yu3Zihan Guo4Shiya Huang5Peixin Cai6Yanliang Miao7Shiying Li8Qian Chen9Xiamen University Affiliated Xiamen Eye Center, Fujian Provincial Key Laboratory of Ophthalmology and Visual Science, Fujian Engineering and Research Center of Eye Regenerative Medicine, Eye Institute of Xiamen University, School of Medicine, Xiamen UniversityXiamen University Affiliated Xiamen Eye Center, Fujian Provincial Key Laboratory of Ophthalmology and Visual Science, Fujian Engineering and Research Center of Eye Regenerative Medicine, Eye Institute of Xiamen University, School of Medicine, Xiamen UniversityXiamen University Affiliated Xiamen Eye Center, Fujian Provincial Key Laboratory of Ophthalmology and Visual Science, Fujian Engineering and Research Center of Eye Regenerative Medicine, Eye Institute of Xiamen University, School of Medicine, Xiamen UniversityXiamen University Affiliated Xiamen Eye Center, Fujian Provincial Key Laboratory of Ophthalmology and Visual Science, Fujian Engineering and Research Center of Eye Regenerative Medicine, Eye Institute of Xiamen University, School of Medicine, Xiamen UniversityXiamen University Affiliated Xiamen Eye Center, Fujian Provincial Key Laboratory of Ophthalmology and Visual Science, Fujian Engineering and Research Center of Eye Regenerative Medicine, Eye Institute of Xiamen University, School of Medicine, Xiamen UniversityXiamen University Affiliated Xiamen Eye Center, Fujian Provincial Key Laboratory of Ophthalmology and Visual Science, Fujian Engineering and Research Center of Eye Regenerative Medicine, Eye Institute of Xiamen University, School of Medicine, Xiamen UniversityXiamen University Affiliated Xiamen Eye Center, Fujian Provincial Key Laboratory of Ophthalmology and Visual Science, Fujian Engineering and Research Center of Eye Regenerative Medicine, Eye Institute of Xiamen University, School of Medicine, Xiamen UniversityXiamen University Affiliated Xiamen Eye Center, Fujian Provincial Key Laboratory of Ophthalmology and Visual Science, Fujian Engineering and Research Center of Eye Regenerative Medicine, Eye Institute of Xiamen University, School of Medicine, Xiamen UniversityDepartment of Ophthalmology, The First Affiliated Hospital of Xiamen UniversityXiamen University Affiliated Xiamen Eye Center, Fujian Provincial Key Laboratory of Ophthalmology and Visual Science, Fujian Engineering and Research Center of Eye Regenerative Medicine, Eye Institute of Xiamen University, School of Medicine, Xiamen UniversityAbstract Macular degeneration is a leading cause of irreversible vision loss, significantly impacting quality of life. To enhance clinical practice and reduce the risk of drug-related macular degeneration, we analyzed drug-related trends using real-world data. Disproportionality analysis of adverse event reports from the FDA Adverse Event Reporting System (FAERS, 2004–2023) identified 67,683 cases involving 1402 drugs. Among these, 42 drugs were linked to significant risks, including treatments for breast cancer (tamoxifen, raloxifene, anastrozole, letrozole) and diabetes (insulin lispro, insulin human). The BCPNN algorithm revealed that 45.2% (19/42) of these drugs had the strongest associations with macular degeneration, with pentosan polysulfate sodium, travoprost, and tolterodine being the highest-risk drugs. Lifitegrast, nicotine, and travoprost were associated with the shortest onset times for ocular adverse events. Among drug classes, glucocorticosteroids were linked to the most rapid onset of ocular side effects (P < 0.001), typically occurring within two months compared to other drugs. Drug-related macular degeneration was more common in women (70.4%) and predominantly affected those aged 60–80. The incidence of drug-related macular degeneration has steadily increased in recent years. This study offers valuable pharmacovigilance insights, highlighting drugs and demographic factors linked to macular degeneration.https://doi.org/10.1038/s41598-024-84679-4FAERSDisproportionality analysisDrug-related macular degenerationMedicationPharmacovigilance
spellingShingle Xiaodong Chen
Shinan Wu
Shaopan Wang
Chaofeng Yu
Zihan Guo
Shiya Huang
Peixin Cai
Yanliang Miao
Shiying Li
Qian Chen
Real world pharmacovigilance assessment of drug related macular degeneration risks
Scientific Reports
FAERS
Disproportionality analysis
Drug-related macular degeneration
Medication
Pharmacovigilance
title Real world pharmacovigilance assessment of drug related macular degeneration risks
title_full Real world pharmacovigilance assessment of drug related macular degeneration risks
title_fullStr Real world pharmacovigilance assessment of drug related macular degeneration risks
title_full_unstemmed Real world pharmacovigilance assessment of drug related macular degeneration risks
title_short Real world pharmacovigilance assessment of drug related macular degeneration risks
title_sort real world pharmacovigilance assessment of drug related macular degeneration risks
topic FAERS
Disproportionality analysis
Drug-related macular degeneration
Medication
Pharmacovigilance
url https://doi.org/10.1038/s41598-024-84679-4
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