不良事件报告系统
医学
药物警戒
不利影响
药品
药理学
作者
Wenxia Zhao,Xin Feng,Shan Yang,Guosen Yuan,Min Huang,Lei Ding,Zhichao He,Junyan Wu
标识
DOI:10.1080/14740338.2025.2491125
摘要
Antibody-drug conjugates (ADCs) have demonstrated remarkable therapeutic efficacy in refractory cancers, however, ophthalmotoxicity remains a serious concern. This study aimed to investigate the association between ADCs and ophthalmotoxicity. A retrospective pharmacovigilance study was conducted utilizing data extracted from the U.S. Food and Drug Administration Adverse Events Reporting System (FAERS) from 2004 to 2023. Disproportionality analyses were performed using the reporting odds ratio (ROR) and information component (IC), with sensitivity analyses and subgroup evaluations by age and sex. A total of 1992 cases of ophthalmotoxicity linked to ADCs were identified, with a median latency of 40 days. The correlation between ophthalmotoxicity and ADCs was higher than with other medications (IC = 0.67, 95% CI:0.64-0.70). Signal detection revealed 36 adverse events unreported in product labeling. Sensitivity analyses confirmed the robustness of our results on the association between ADCs and ocular toxicity, with higher reporting in females compared to males (OR = 1.25, 95% CI: 1.11-1.40). ADCs had different profiles of ophthalmotoxicity. Our pharmacovigilance study suggested increased reporting of ophthalmotoxicity associated with ADCs.
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