Qiu Weiwen, Wang Dongdong, Deng Junyi, Jin Liuyin
People's Hospital of Dianbai, Maoming City, Guangdong, China.
Mingzhou East Rehabilitation Hospital, Ningbo, China.
Naunyn Schmiedebergs Arch Pharmacol. 2025 Sep 18. doi: 10.1007/s00210-025-04610-0.
Atypical antipsychotic medications are widely used in the treatment of schizophrenia and other psychiatric disorders; however, emerging evidence suggests a possible link between these agents and glaucoma. As glaucoma is a debilitating condition that can cause irreversible vision loss, clarifying its relationship with antipsychotic use is crucial to guide clinical decision-making. This study utilized the FDA Adverse Event Reporting System (FAERS), a spontaneous reporting database, to explore potential associations between atypical antipsychotic medications and glaucoma. Relevant adverse event reports were systematically retrieved and analyzed through disproportionality methods. The analysis first focused on medications with a higher number of reported cases, followed by a more detailed assessment that incorporated patient-level characteristics. The disproportionality analysis revealed a signal of angle-closure glaucoma associated with olanzapine, with all four statistical measures exceeding predefined thresholds (ROR = 4.64, 95% CI: 3.07-7.01; PRR = 3.33, 95% CI: 2.53-4.38; IC = 1.70, IC025 = 1.16; EBGM = 3.26, EBGM05 = 2.30). In contrast, other antipsychotics such as quetiapine and aripiprazole showed increases in certain metrics but did not simultaneously meet all criteria. The convergence of significant results across multiple methods for olanzapine indicates a more consistent statistical signal of angle-closure glaucoma compared with other agents. However, given the inherent limitations of spontaneous reporting systems, these findings should be interpreted cautiously. This study identified several potential safety signals of glaucoma associated with atypical antipsychotics in the FAERS database, with the statistical signal for olanzapine and angle-closure glaucoma being particularly notable. It is important to emphasize that disproportionality analysis detects reporting signals rather than establishing causality; these findings are therefore hypothesis-generating and intended to raise clinical awareness. Further validation using prospective studies, electronic health records, or other real-world data sources is required to clarify the clinical significance of these observations. In clinical practice, especially for patients with preexisting ocular conditions or elevated intraocular pressure, physicians should strengthen risk assessment, adopt individualized prescribing strategies, and consider regular ophthalmologic evaluations to help manage potential risks.
非典型抗精神病药物广泛用于治疗精神分裂症和其他精神障碍；然而，新出现的证据表明这些药物与青光眼之间可能存在联系。由于青光眼是一种使人衰弱的疾病，可导致不可逆转的视力丧失，因此明确其与抗精神病药物使用之间的关系对于指导临床决策至关重要。本研究利用美国食品药品监督管理局不良事件报告系统（FAERS）这一自发报告数据库，探讨非典型抗精神病药物与青光眼之间的潜在关联。通过不成比例分析方法系统检索和分析相关不良事件报告。分析首先聚焦于报告病例数较多的药物，随后进行更详细的评估，纳入患者层面的特征。不成比例分析显示奥氮平与闭角型青光眼存在关联信号，所有四项统计指标均超过预定阈值（相对危险度=4.64，95%置信区间：3.07-7.01；比例报告比值比=3.33，95%置信区间：2.53-4.38；信息成分=1.70，信息成分下限=1.16；经验贝叶斯几何均数=3.26，经验贝叶斯几何均数下限=2.30）。相比之下，其他抗精神病药物如喹硫平和阿立哌唑在某些指标上有所增加，但并未同时满足所有标准。多种方法对奥氮平得出的显著结果趋同，表明与其他药物相比，闭角型青光眼的统计信号更为一致。然而，鉴于自发报告系统的固有局限性，这些发现应谨慎解读。本研究在FAERS数据库中识别出非典型抗精神病药物与青光眼相关的几个潜在安全信号，奥氮平与闭角型青光眼的统计信号尤为显著。需要强调的是，不成比例分析检测的是报告信号而非确立因果关系；因此这些发现只是产生假设，旨在提高临床意识。需要使用前瞻性研究、电子健康记录或其他真实世界数据源进行进一步验证，以阐明这些观察结果的临床意义。在临床实践中，尤其是对于已有眼部疾病或眼压升高的患者，医生应加强风险评估，采用个体化的处方策略，并考虑定期进行眼科评估，以帮助管理潜在风险。
