Drug-related macular edema: a real-world FDA Adverse Event Reporting System database study.

IF 2.8 3区医学 Q2 PHARMACOLOGY & PHARMACY

BMC Pharmacology & Toxicology Pub Date : 2025-01-30 DOI:10.1186/s40360-025-00856-9

Xiang Li, Yi-Qing Sun, Qiong-Lian Huang, Zhi-Jie Zhang, Li-Qiang Shi, Jia-Feng Tang, Zhan-Yang Luo

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引用次数: 0

Abstract

Purpose: This study aims to assess the risks associated with drug-induced macular edema and to examine the epidemiological characteristics of this condition.

Methods: This study analyzed data from the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database from January 2004 to June 2024 to conduct a disproportionality analysis identifying drugs with positive signals of drug-induced ME. Additionally, the onset time of ME associated with these drugs was examined.

Results: In the FAERS database, a total of 490 drugs were reported to pose a risk of drug-induced ME. Disproportional analysis and screening further identified 8 drugs that significantly increased this risk. Among these, one is ophthalmic drugs, including Latanoprost (ROR = 5.51), and ten are non-ophthalmic drugs, including Cefuroxime (ROR = 75.93), Fingolimod (ROR = 30.69), and Siponimod (ROR = 20.51).

Conclusions: This study utilizes the FAERS database to investigate potential associations between drug use and the occurrence of ME, rapidly identify drugs that may induce the condition, and propose research strategies. These findings hold significant value for guiding clinical medication practices.

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药物相关性黄斑水肿：真实世界FDA不良事件报告系统数据库研究。

目的：本研究旨在评估药物性黄斑水肿的相关风险，并探讨这种情况的流行病学特征。方法：本研究分析美国食品药品监督管理局（FDA）不良事件报告系统（FAERS）数据库2004年1月至2024年6月的数据，对具有药物性ME阳性信号的药物进行歧化分析。此外，还检查了与这些药物相关的ME发病时间。结果：在FAERS数据库中，共有490种药物被报道具有药物性ME的风险。非比例分析和筛选进一步确定了8种显著增加这种风险的药物。其中眼用药物1个，包括拉坦前列素（ROR = 5.51）；非眼用药物10个，包括头孢呋辛（ROR = 75.93）、Fingolimod （ROR = 30.69）、西泊尼莫德（ROR = 20.51）。结论：本研究利用FAERS数据库调查药物使用与ME发生之间的潜在关联，快速识别可能诱发ME的药物，并提出研究策略。这些发现对指导临床用药实践具有重要价值。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

BMC Pharmacology & Toxicology PHARMACOLOGY & PHARMACYTOXICOLOGY&nb-TOXICOLOGY

CiteScore

4.80

自引率

0.00%

发文量

审稿时长

12 weeks

期刊介绍： BMC Pharmacology and Toxicology is an open access, peer-reviewed journal that considers articles on all aspects of chemically defined therapeutic and toxic agents. The journal welcomes submissions from all fields of experimental and clinical pharmacology including clinical trials and toxicology.