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ORIGINAL RESEARCH article

Front. Pharmacol.
Sec. Pharmacoepidemiology
Volume 15 - 2024 | doi: 10.3389/fphar.2024.1480269

Drug-Induced Retinal Vein Occlusion: A Disproportionality Analysis From the FDA Adverse Event Reporting System (2004-2023)

Provisionally accepted
Xiaodong Chen Xiaodong Chen 1,2,3Kunhong Xiao Kunhong Xiao 3Chaobing Zhou Chaobing Zhou 1*
  • 1 Department of Ophthalmology, Hui'an County Hospital, Quanzhou, Fujian, 362100, China., Quanzhou, Fujian Province, China
  • 2 Eye Institute, Xiamen University, Xiamen, Fujian Province, China
  • 3 Department of Ophthalmology and Optometry, Fujian Medical University, Fuzhou, China

The final, formatted version of the article will be published soon.

    Introduction: Retinal vein occlusion (RVO) often causes irreversible visual impairment, making early prevention crucial. This study aims to identify associations between different medications and RVO and provide information for clinical practice. Method: This study included reports of RVO from the FDA Adverse Event Reporting System (FAERS) database from the first quarter (Q1) of 2004 to the fourth quarter (Q4) of 2023. The reported drugs were analyzed for adverse drug reaction (ADR) signals using four disproportionality algorithms. Kaplan-Meier curves and median time to onset were used to evaluate the drugs. Results: From 2004 to 2023, the FAERS database recorded 6,151 reports associated with RVO. Disproportionality analyses identified 25 drugs significantly associated with RVO. Mirabegron showed the highest risk signal, followed by Raloxifene, Tadalafil, Fingolimod, and Bimatoprost. These high-risk drugs are distributed across different therapeutic areas, including urogenital system and sex hormones, ophthalmic drugs, nervous system drugs, musculoskeletal system drugs, anti-tumor and immune-modulating drugs, and anti-parasitic drugs. Specific drug targets such as adrenergic receptor agonists, hormone regulators, and PDE5 inhibitors were identified as high risk. Ophthalmic drugs exhibited the longest median time to adverse ocular reactions at 532.01 days, followed by anti-parasitic drugs, nervous system drugs, urogenital system and sex hormone drugs, anti-tumor and immune-modulating drugs, and musculoskeletal system drugs. Conclusion: This study provides an overview of drug-induced RVO, identifying potential culprit drugs and their distribution characteristics. These findings enhance understanding of medication safety and help optimize clinical practice.

    Keywords: Retinal Vein Occlusion, FDA Adverse Event Reporting System, Disproportionality analysis, Pharmacovigilance, adverse events

    Received: 13 Aug 2024; Accepted: 19 Nov 2024.

    Copyright: © 2024 Chen, Xiao and Zhou. 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: Chaobing Zhou, Department of Ophthalmology, Hui'an County Hospital, Quanzhou, Fujian, 362100, China., Quanzhou, Fujian Province, 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.