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

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.