Introduction: Esketamine nasal spray received approval for treatment-resistant depression in March 2019. Objective: Using the FDA Adverse Event Reporting System (FAERS) database (March 2019–March 2020), we analysed esketamine-related adverse events (AEs) to detect and characterize relevant safety signals. Methods: We used the consolidated case/non-case approach to estimate the reporting odds ratio (ROR) and information component (IC) with relevant confidence intervals (95% CI) for esketamine-related AEs with ≥4 counts. Comparisons between serious and non-serious AEs were performed using non-parametric tests. Results: The FAERS database contained 962 cases of esketamine-related AEs, with signals detected for several AEs, such as dissociation (ROR = 1,612.64, 95% CI = 1,354.63, 1,919.79; IC = 8.19, 95% CI = 7.96, 8.35), sedation (ROR = 238.46, 95% CI = 202.98, 280.15; IC = 7, 95% CI = 6.75, 7.18), feeling drunk (ROR = 96.17, 95% CI = 61.42, 150.57; IC = 4.84, 95% CI = 4.09, 5.36), suicidal ideation (ROR = 24.03, 95% CI = 18.72, 30.84; IC = 4.31, 95% CI = 3.9, 4.61), and completed suicide (ROR = 5.75, 95% CI = 3.18, 10.41; IC = 2.25, 95% CI = 1.23, 2.94). Signals for suicidal and self-injurious ideation, but not suicide attempt and completed suicide, remained when comparing esketamine to venlafaxine. Females and patients receiving antidepressant polypharmacy, co-medication with mood stabilizers, antipsychotics, benzodiazepines, or somatic medications were more likely to suffer from serious versus non-serious AEs (χ² = 125.29, p #x3c; 0.001, χ² = 9.08, p = 0.003, χ² = 8.14, p = 0.004, χ² = 19.48, p #x3c; 0.001, χ² = 25.62, p #x3c; 0.001, and χ² = 16.79, p #x3c; 0.001, respectively). Conclusions: Esketamine may carry a clear potential for serious AEs, which deserves urgent clarification by means of further prospective studies.
Psychother Psychosom

中文翻译：

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Esketamine 的上市后安全问题：对提交给 FDA 不良事件报告系统的自发报告的不成比例分析。

简介：艾氯胺酮鼻喷雾剂于 2019 年 3 月获得批准用于治疗难治性抑郁症。目标：使用 FDA 不良事件报告系统 (FAERS) 数据库（2019 年 3 月至 2020 年 3 月），我们分析了与艾氯胺酮相关的不良事件 (AE)，以检测和表征相关的安全信号。方法：我们使用合并病例/非病例方法来估计计数≥4 的艾氯胺酮相关 AE 的报告比值比 (ROR) 和信息成分 (IC) 以及相关置信区间 (95% CI)。使用非参数检验进行严重和非严重 AE 之间的比较。结果：FAERS 数据库包含 962 例与艾氯胺酮相关的 AE，检测到几种 AE 的信号，例如解离（ROR = 1,612.64, 95% CI = 1,354.63, 1,919.79; IC = 8.19, 95% CI = 7.35, edation） ROR = 238.46, 95% CI = 202.98, 280.15; IC = 7, 95% CI = 6.75, 7.18), 感觉醉了 (ROR = 96.17, 95% CI = 61.42, 150.57; IC, = 95% CI, = 95.8) 5.36)、自杀意念 (ROR = 24.03, 95% CI = 18.72, 30.84; IC = 4.31, 95% CI = 3.9, 4.61) 和完全自杀 (ROR = 5.75, 95% CI = 3.18, 50 , 95% CI = 1.23, 2.94)。将艾氯胺酮与文拉法辛进行比较时，仍有自杀和自伤意念的信号，但没有自杀未遂和完成自杀的信号。接受抗抑郁药多药治疗、与情绪稳定剂、抗精神病药、苯二氮卓类药物联合用药的女性和患者，² = 125.29，p #x3c；0.001, χ ² = 9.08, p = 0.003, χ ² = 8.14, p = 0.004, χ ² = 19.48, p #x3c; 0.001, χ ² = 25.62, p #x3c; 0.001，和χ ² = 16.79，p＃X3C; 0.001，分别）。结论：艾氯胺酮可能具有明显的严重 AE 潜力，值得通过进一步的前瞻性研究紧急澄清。
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