A real-world population-based study on the association between cataracts and antipsychotics.

Objective: 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.

Methods: An observational, population-based pharmacovigilance study. Methods: All reports of cataracts submitted to the U.S. Food and Drug Administration involving FGAs and SGAs. Methods: We searched the United States Food and Drug Administration Adverse Event Reporting System (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.

Results: 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] IC025 = 1.23) and quetiapine (ROR1: 64; 95% CI = 1.44%-1.88%; p < 0.0001; IC025 = 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 vigilance and regular ocular monitoring in individuals prescribed antipsychotics.