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

Area of Science:

• Ophthalmology
• Pharmacovigilance
• Drug Safety

Background:

• Limited evidence exists linking medications to lacrimal drainage obstruction, primarily from case reports.
• Real-world data offers a valuable resource for identifying potential drug-related adverse events (AEs).

Purpose of the Study:

• To investigate associations between specific drugs and lacrimal drainage obstruction-related AEs.
• To utilize the Food and Drug Administration Adverse Event Reporting System (FAERS) for pharmacovigilance analysis.

Main Methods:

• Conducted a pharmacovigilance analysis of lacrimal drainage obstruction AEs reported to FAERS (October 2003 - December 2024).
• Employed disproportionality analyses, including reporting odds ratios (RORs) and Bayesian confidence propagation neural network algorithms, to detect adverse drug reaction signals.

Main Results:

• Identified fourteen pharmacological agents disproportionately associated with lacrimal drainage obstruction AEs.
• Sodium iodide I-131, netarsudil, and docetaxel showed the highest disproportionate reporting.
• Radiopharmaceuticals, chemotherapy agents, and ophthalmic agents were the most frequently implicated drug classes.

Conclusions:

• This is the first pharmacovigilance study of lacrimal drainage obstruction AEs using FAERS data.
• Significant associations were found with sodium iodide I-131, netarsudil, and docetaxel.
• Enhanced clinician awareness is vital for patients at risk, with further research needed to confirm causality and develop prevention strategies.