Signals of drug-related retinal artery occlusion: a multi-country retrospective study from a spontaneous reporting system.

OBJECTIVE

This study aimed to systematically identify systemic drugs associated with retinal artery occlusion (RAO) using real-world data from the US FDA Adverse Event Reporting System (FAERS).

METHODS

FAERS reports from January 2004 to December 2024 were analyzed. Disproportionality analyses (ROR, PRR, BCPNN, and MGPS) were applied to detect signals of disproportionate reporting. Drugs were further evaluated based on signal strength and time-to-onset characteristics.

RESULTS

A total of 626 drugs were initially screened, among which 36 drugs were identified as having significant disproportionality signals for RAO. These drugs were categorized into several pharmacological classes, including antineoplastic agents, anti-VEGF agents, reproductive system medications, anesthetics, anti-inflammatory drugs, hormonal agents, and others. Strong signals, as indicated by the BCPNN algorithm, were observed for mepivacaine, brolucizumab, and pegaptanib. Anesthetic agents exhibited the shortest median time to onset.

CONCLUSION

This study characterizes the reporting patterns and signal strength of RAO across multiple drug classes using pharmacovigilance data. These findings provide real-world evidence to enhance clinical awareness and support safer prescribing practices, while emphasizing the need for further validation in controlled studies.