| アブストラクト | BACKGROUND: Serotonin-norepinephrine reuptake inhibitors (SNRIs) are widely used in the treatment of neuropsychiatric disorders and chronic pain; however, their comprehensive ocular safety profile has not been systematically evaluated. This study aimed to investigate and compare the safety signals of ocular adverse events (AEs) associated with five major SNRIs (venlafaxine, duloxetine, desvenlafaxine, milnacipran, and levomilnacipran). METHODS: This was a retrospective pharmacovigilance analysis. Ocular AEs associated with the SNRIs were extracted from the FAERS database (Q1 2004-Q4 2024). Disproportionality analyses were conducted using four algorithms, proportional reporting ratio (PRR), reporting odds ratio (ROR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS), to identify statistically significant signals. Time-to-onset analysis and sex subgroup analyses were also performed. RESULTS: A total of 5,860 SNRI-related ocular AEs were included. At the System Organ Class level, no significant positive signals of ocular AEs were observed. At the Preferred Term (PT) level, distinct risk profiles emerged for different SNRIs. Mydriasis was one of the strongest and most common signals for duloxetine, desvenlafaxine, and venlafaxine. Venlafaxine was also strongly associated with anisocoria and accommodation disorder. Vision blurred and visual impairment were the most frequently reported Preferred Term across all drugs. TTO analysis revealed that AEs occurred later for levomilnacipran (median 161 days) and venlafaxine (median 147 days), but earlier for desvenlafaxine (31 days) and milnacipran (11.5 days). Sex subgroup analyses revealed significant differences. CONCLUSION: Based on real-world data, this study identified drug-specific and sex-specific differences in the ocular safety signals of SNRIs. Mydriasis represents a common strong risk signal across multiple SNRIs. |
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