To systematically identify systemic drugs associated with retinal artery occlusion (RAO) using real-world data from the US FDA Adverse Event Reporting System (FAERS).
Approach:
Data Source: FAERS reports from January 2004 to December 2024 were analyzed, focusing on adverse events related to RAO.
Signal Detection: Disproportionality analyses (ROR, PRR, BCPNN, MGPS) were applied to detect signals of disproportionate reporting for 626 drugs.
Key Findings:
36 drugs were identified with significant disproportionality signals for RAO.
Drugs were categorized into pharmacological classes including antineoplastic agents, anti-VEGF agents, anesthetics, anti-inflammatory drugs, hormonal agents, and others.
Strong signals for RAO were observed for mepivacaine, brolucizumab, and pegaptanib.
Anesthetic agents had the shortest median time to onset of RAO.
Interpretation:
The study characterizes reporting patterns and signal strength of RAO across multiple drug classes using pharmacovigilance data.
Limitations:
The study relies on spontaneous reporting data, which may be subject to underreporting and reporting biases that could affect the findings.
The analysis excludes consumer-reported cases to enhance clinical consistency.
Conclusion:
The findings provide real-world evidence regarding drug associations with RAO, while emphasizing the need for further validation in controlled studies.
The key is execution, understanding the clinical landscape, controlling device cost, engineering the intraoperative workflow, and scheduling/staffing with intention.