Lakhani Moiz, Kwan Angela T H, Chaudry Emaan, Popovic Marko, Xie Jim Shenchu, Rai Amrit S, Rai Amandeep S, Margolin Edward A, McIntyre Roger S
Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada; Brain and Cognition Discovery Foundation, Toronto, ON, Canada.
Department of Ophthalmology, University of Ottawa, Ottawa, ON, Canada; The University of Ottawa Eye Institute, Ottawa, ON, Canada.
Can J Ophthalmol. 2025 Jun 23. doi: 10.1016/j.jcjo.2025.05.021.
It is uncertain whether first- (FGAs) and second-generation antipsychotic (SGAs) drugs are associated with development of cataract. We conducted a real-world adverse event (AE) disproportionality analysis of cataracts in individuals exposed to antipsychotics.
An observational, population-based pharmacovigilance study.
All reports of cataracts submitted to the U.S. Food and Drug Administration involving FGAs and SGAs.
We searched the United States Food and Drug Administration Adverse Event Reporting System (FAERS) (2003 Q4-2024 Q1) for cataract reports associated with antipsychotics, analyzing data with OpenVigil 2.1. Reporting odds ratios (RORs), p values (with a Bonferroni-adjusted significance threshold of 0.0019), and Bayesian Confidence Propagation Neural Network information components (IC) were reported.
We retrieved 12,345,128 unique AE reports (5.4% females, 34.5% males), including 34,879 cataract reports and 372,107 antipsychotic reports (10,274 FGAs and 361,833 SGAs). Chlorpromazine (ROR: 7.60; 95%; confidence interval [CI] = 3.78%-15.29%; p < 0.0001; [lower limit of the 95% credibility interval for the information component] IC = 1.23) and quetiapine (ROR1: 64; 95% CI = 1.44%-1.88%; p < 0.0001; IC = 0.48) showed significantly higher odds of cataract reporting compared to all other drugs. No significantly higher reporting odds of cataracts were found for the 10 FGAs and 14 SGAs studied. However, increased cataract reporting was observed for chlorpromazine in females and for quetiapine in both sexes. This pattern also occurred in both drugs in the 18-44 and 45-64 age groups, with greater magnitude in the younger group CONCLUSIONS: Cataract development was disproportionately reported after the use of certain FGAs and SGAs. Although a cause-and-effect relationship cannot be established, these findings underscore the importance of clinical vigilance and regular ocular monitoring in individuals prescribed antipsychotics.
第一代抗精神病药物（FGAs）和第二代抗精神病药物（SGAs）是否与白内障的发生有关尚不确定。我们对使用抗精神病药物的个体进行了白内障的真实世界不良事件（AE）不成比例分析。
一项基于人群的观察性药物警戒研究。
提交给美国食品药品监督管理局的所有涉及FGAs和SGAs的白内障报告。
我们在美国食品药品监督管理局不良事件报告系统（FAERS）（2003年第四季度至2024年第一季度）中搜索与抗精神病药物相关的白内障报告，使用OpenVigil 2.1分析数据。报告了报告比值比（RORs）、p值（采用Bonferroni校正的显著性阈值0.0019）和贝叶斯置信传播神经网络信息成分（IC）。
我们检索到12345128份独特的不良事件报告（女性占5.4%，男性占34.5%），包括34879份白内障报告和372107份抗精神病药物报告（10274份FGAs和361833份SGAs）。氯丙嗪（ROR：7.60；95%；置信区间[CI] = 3.78%-15.29%；p < 0.0001；[信息成分的95%可信区间下限]IC = 1.23）和喹硫平（ROR1：64；95% CI = 1.44%-1.88%；p < 0.0001；IC = 0.48）与所有其他药物相比，白内障报告的几率显著更高。在所研究的10种FGAs和14种SGAs中，未发现白内障报告几率显著更高的情况。然而，观察到氯丙嗪在女性中以及喹硫平在两性中白内障报告增加。这种模式在18-44岁和45-64岁年龄组的两种药物中也出现，在较年轻组中更为明显。结论：在使用某些FGAs和SGAs后，白内障的发生报告不成比例。虽然无法确定因果关系，但这些发现强调了对使用抗精神病药物的个体进行临床警惕和定期眼部监测的重要性。
