Corneal Complications: Drug-Induced Deposits and Food and Drug Administration Adverse Event Reporting System Data Insights—A Retrospective Study

Abstract

Purpose:

The aim of this study was to identify and quantify the occurrence of corneal deposits caused by medications, utilizing data from the Food and Drug Administration Adverse Event Reporting System (FAERS).

Methods:

We conducted a retrospective analysis of the national FAERS database, focusing on instances of drug-induced corneal deposits reported between 2004 and the third quarter of 2023. Our methodology included applying the proportional reporting ratio, reporting odds ratio, empirical Bayes geometric mean, and information component in our disproportionality analysis. A signal was considered present if all four of these disproportionality metrics showed positive results.

Results:

Over the span of 20 years, our research identified 383 adverse event reports linked to corneal deposits associated with 349 different medications. The most common age-group of these reports involved patients over 65 years of age (32.4%), with equal distribution between male (40.0%) and female (42.8%) patients. Thirty-one medications showed a positive signal. Notably, drugs such as amiodarone (68 reports), prednisolone (60 reports), and timolol (54 reports) were most frequently mentioned. Cyclopentolate and chloramphenicol demonstrated robust statistical relevance in association with corneal deposits.

Conclusions:

Positive signals for drug-induced corneal deposits included both well-known medications such as amiodarone and lesser-studied medications such as prednisolone and timolol. Clinician awareness of these findings alongside further investigation is needed.