Drug-related visual blurring: findings from the U.S. Food and Drug Administration Adverse Event Reporting System database

Abstract

Background

Visual blurring is one of the most common symptoms in ophthalmology, and one of the important causes of secondary visual blurring is drug-related. This study assesses the risk of drug-related visual blurring using a large real-world database.

Methods

We analyzed adverse event reports from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database between January 2004 and September 2024. Disproportionality analysis algorithm were used. Drugs related with positive signals for visual blurring were categorized, and the risk levels, number of reports, and drug-induced onset times were quantified.

Results

Disproportionality analysis of the FAERS database identified 119 drugs with positive signals for visual blurring, primarily in the following categories: ophthalmic medications (Lifitegrast, Reporting Odds Ratio [ROR] = 53.24; 95 % Confidence Interval [CI]: 49.19–57.61), endocrine medications (Semaglutide, ROR = 3.26 [2.84–3.75]), nervous system medications (Pregabalin, ROR = 4.15 [3.93–4.37]), oncology medications (Encorafenib, ROR = 5.38 [4.37–6.62]), antimuscarinic medications (Fesoterodine, ROR = 6.77 [5.08–9.03]), and other medications (Dupilumab, ROR = 8.39 [8.16–8.64]). The top three drugs associated with the highest incidence of blurred vision as an adverse event are lifitegrast, oxymetazoline, and olopatadine. Antimuscarinic Medications had the shortest drug-induced onset time. Women (63.87 %) and middle-aged to elderly individuals [Age (mean ± standard deviation): 53.59 ± 18.79] were the main populations affected by drug-related visual blurring.

Conclusion

Preventing drug-related vision issues is vital. Early risk assessment and intervention with personalized medication can reduce side effects, ensure safety, and improve quality of life.