Clinical therapeutics · 2026
Adverse Drug Events Associated With Six Classes of Glaucoma Medications: A Retrospective Pharmacovigilance Study Using Real-World Data From The FAERS Database.
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Jiang Yuqi, Wu Shinan, Chen Yuling, Xu Changsheng, Liu Zuguo, Wu Yalin
Аннотация
PURPOSE: Comparative post-marketing safety evidence across commonly used antiglaucoma drug classes remains limited. We conducted a real-world pharmacovigilance study to compare adverse event reporting patterns associated with 6 major classes of glaucoma medications using the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS).
METHODS: FAERS reports from 2004 to 2024 were analyzed for 6 antiglaucoma drug classes. Baseline characteristics were summarized descriptively. Safety signals were identified using 4 disproportionality methods: reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson Shrinker. Time-to-onset was compared across drug classes.
FINDINGS: A total of 13,703 prostaglandin analog, 7,108 adrenergic agonist, 3,149 carbonic anhydrase inhibitor, 399 β-blocker, 149 cholinergic agonist, and 424 fixed-combination cases were identified. Ocular events were most frequently reported, but each class showed distinct safety signals. Prostaglandin analogs showed prominent signals for madarosis and eyelid pigmentation; adrenergic agonists for flushing, skin burning sensation, and rash macular; carbonic anhydrase inhibitors for eye allergy, ocular irritation-related events, hypoacusis, dysgeusia, and a systemic signal of interest for metabolic acidosis; β-blockers for bradycardia, arrhythmia, and atrioventricular block; and cholinergic agonists for vitreous detachment, vitreous opacity, and retinal detachment. Compound preparations showed signals including punctate keratitis, cataract, retinal detachment, eye pain, and visual acuity reduced. Among date-complete reports, time-to-onset differed across drug classes, with cholinergic agonists showing the shortest mean onset time and β-blockers the longest.
IMPLICATIONS: This FAERS-based study compared post-marketing adverse event reporting patterns across 6 major antiglaucoma medication classes. Most signals were ocular, periocular, or visual-function related, with selected nonocular signals also observed. These findings are hypothesis-generating and warrant further clinical validation.
METHODS: FAERS reports from 2004 to 2024 were analyzed for 6 antiglaucoma drug classes. Baseline characteristics were summarized descriptively. Safety signals were identified using 4 disproportionality methods: reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson Shrinker. Time-to-onset was compared across drug classes.
FINDINGS: A total of 13,703 prostaglandin analog, 7,108 adrenergic agonist, 3,149 carbonic anhydrase inhibitor, 399 β-blocker, 149 cholinergic agonist, and 424 fixed-combination cases were identified. Ocular events were most frequently reported, but each class showed distinct safety signals. Prostaglandin analogs showed prominent signals for madarosis and eyelid pigmentation; adrenergic agonists for flushing, skin burning sensation, and rash macular; carbonic anhydrase inhibitors for eye allergy, ocular irritation-related events, hypoacusis, dysgeusia, and a systemic signal of interest for metabolic acidosis; β-blockers for bradycardia, arrhythmia, and atrioventricular block; and cholinergic agonists for vitreous detachment, vitreous opacity, and retinal detachment. Compound preparations showed signals including punctate keratitis, cataract, retinal detachment, eye pain, and visual acuity reduced. Among date-complete reports, time-to-onset differed across drug classes, with cholinergic agonists showing the shortest mean onset time and β-blockers the longest.
IMPLICATIONS: This FAERS-based study compared post-marketing adverse event reporting patterns across 6 major antiglaucoma medication classes. Most signals were ocular, periocular, or visual-function related, with selected nonocular signals also observed. These findings are hypothesis-generating and warrant further clinical validation.