Real-world analysis of medications inducing meibomian gland dysfunction: based on the FDA adverse event reporting system database

Expert Opin Drug Saf. 2025 Jan 3. doi: 10.1080/14740338.2024.2446430. Online ahead of print.

Abstract

Background: Dry eye syndrome (DES) has become a significant public health issue, impacting quality of life. Meibomian Gland Dysfunction (MGD) is a primary contributor to DES, and its etiology includes diverse factors. Given the potential for drug-induced MGD, comprehensive investigation into this association is crucial.

Research design and methods: This study aims to identify and analyze signals associated with drug-induced MGD risk, enhancing drug safety evaluation. Data from the FDA Adverse Event Reporting System (FAERS) from January 2004 to September 2023 were analyzed using statistical algorithms, including the Ratio of Odds Ratios (ROR) and Proportional Reporting Ratio (PRR), to detect potential adverse reaction signals. Drugs associated with MGD were categorized across therapeutic classes.

Results: Analysis of 289 cases reporting MGD as an adverse reaction revealed an average patient age of 51.69 years, with 65.44% female. The annual number of MGD reports has increased since the establishment of FAERS database, peaking in 2023, mainly from the United States and European countries. Disproportionate analysis of 148 drugs identified 9 associated with MGD adverse events, including ophthalmology, oncology, immunomodulation, dermatology, and urogenital system.

Conclusion: This study provides real-world data from the identification of drugs potentially inducing MGD and offers a comprehensive approach to exploring MGD-related drug safety. Our findings support the development of pharmacovigilance strategies for drug-induced ocular conditions and contribute to optimized drug management in clinical practice.

Keywords: Dry eye syndrome; FAERS database; Real-world study; adverse drug reactions; meibomian gland dysfunction.