Drug-associated lacrimal drainage obstruction: a population-based pharmacovigilance study.

PURPOSE: Evidence linking medications to lacrimal drainage obstruction is limited, primarily consisting of case reports. This study investigated associations between drugs and lacrimal drainage obstruction-related adverse events (AEs) using real-world data from the Food and Drug Administration Adverse Event Reporting System (FAERS).

METHODS

A pharmacovigilance analysis of lacrimal drainage obstruction-related AEs reported to FAERS from October 2003 through December 2024 was conducted using Open Vigil 2.1 (Kiel, Germany). Disproportionality analyses were performed using reporting odds ratios (RORs) and Bayesian confidence propagation neural network algorithms to identify adverse drug reaction signals.

RESULTS

Fourteen pharmacological agents were disproportionately associated with lacrimal drainage obstruction-related AEs. Sodium iodide I-131 (ROR = 399.7, 95%CI=[262.8, 608.0]), netarsudil (ROR = 350.6, 95%CI=[242.7, 506.5]) and docetaxel (ROR = 168.7, 95%CI=[145.8, 195.3]) showed the highest disproportionate reporting of lacrimal drainage obstruction-related AEs. These were followed by carboxymethylcellulose (ROR = 39.4, 95%CI=[16.4, 95.1]), ketotifen (ROR = 32.9, 95%CI=[12.3, 88.0]), and glycerin (ROR = 31.7, 95%CI=[11.8, 84.6]). The most common drug classes were radiopharmaceuticals, chemotherapy agents, and ophthalmic agents.

CONCLUSIONS

This study represents the first pharmacovigilance analysis of lacrimal drainage obstruction-related AEs using FAERS data. Significant associations were identified with several medications, notably sodium iodide I-131, netarsudil, and docetaxel. Clinician awareness is important, particularly for patients at elevated risk. Further research is needed to clarify causality and inform prevention strategies.