Li Liangxia, Xu Qianqian, Pang Liangfang, Liu Yarui, Lu Yuanyuan
Department of Pharmacy, Maternal and Child Health Hospital of Hubei Province, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Front Pharmacol. 2025 May 2;16:1519865. doi: 10.3389/fphar.2025.1519865. eCollection 2025.
Vortioxetine is a novel antidepressant belonging to the class of selective serotonin reuptake inhibitors. This study aims to comprehensively analyze the adverse events (AEs) associated with vortioxetine by analyzing the FDA Adverse Event Reporting System (FAERS) database.
This study collected reports of vortioxetine as primary suspected drug in FAERS database from the fourth quarter of 2013 to the fourth quarter of 2023. We conducted disproportionality analysis to quantify signals of AEs using the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN) and Multi-item Gamma-Poisson Shrinker (MGPS).
A total of 12,279 reports of vortioxetine as the primary suspected drug and 30,104 AEs were identified. 51.57% of AE reports originated from consumers and 45.85% from health professional. The AEs associated with vortioxetine involved 27 different system organs (SOCs). A total of 158 AE signals of vortioxetine were identified, including some common adverse events such as nausea, vomiting, and unexpected AE signals such as vision blurred, bruxism, disturbance in attention, akathisia, restless legs syndrome, urinary retention, and electrocardiogram QT prolonged. Gender-specific analysis showed high-risk AEs were different for females (nausea, vomiting, crying, contusion, weight increased, pruritus) and males (completed suicide, negative thoughts, anorgasmia, libido decreased, urinary retention, sexual dysfunction). The median onset time of AEs was 7 days (interquartile range [IQR] 0-30 days), and most AEs (75.10%) occurred within the first month after initiation of vortioxetine.
Our study identified potential new AE signals, offering a broader understanding of the safety profile of vortioxetine, and providing valuable references for its clinical monitoring and further research. It should be noted that nearly half of the reports originated from patients, highlighting the value of patient-reported data in pharmacovigilance, but also reminding us of the need for cautious interpretation due to potential self-reporting biases.
伏硫西汀是一种新型抗抑郁药，属于选择性5-羟色胺再摄取抑制剂类。本研究旨在通过分析美国食品药品监督管理局不良事件报告系统（FAERS）数据库，全面分析与伏硫西汀相关的不良事件（AE）。
本研究收集了2013年第四季度至2023年第四季度FAERS数据库中以伏硫西汀为主要可疑药物的报告。我们进行了不成比例分析，使用报告比值比（ROR）、比例报告比（PRR）、贝叶斯置信传播神经网络（BCPNN）和多项目伽马-泊松收缩器（MGPS）来量化AE信号。
共确定了12279份以伏硫西汀为主要可疑药物的报告和30104例AE。51.57%的AE报告来自消费者，45.85%来自医疗专业人员。与伏硫西汀相关的AE涉及27个不同的系统器官分类（SOC）。共确定了158个伏硫西汀的AE信号，包括一些常见的不良事件，如恶心、呕吐，以及一些意外的AE信号，如视力模糊、磨牙症、注意力障碍、静坐不能、不宁腿综合征、尿潴留和心电图QT间期延长。性别特异性分析显示，女性（恶心、呕吐、哭泣、挫伤、体重增加、瘙痒）和男性（自杀未遂、消极想法、性高潮缺失、性欲减退、尿潴留、性功能障碍）的高危AE有所不同。AE的中位发病时间为7天（四分位间距[IQR]0 - 30天），大多数AE（75.10%）发生在开始使用伏硫西汀后的第一个月内。
我们的研究确定了潜在的新AE信号，有助于更全面地了解伏硫西汀的安全性概况，并为其临床监测和进一步研究提供有价值的参考。需要注意的是，近一半的报告来自患者，这突出了患者报告数据在药物警戒中的价值，但也提醒我们由于潜在的自我报告偏差，需要谨慎解读。
