Department of Medical and Clinical Pharmacology, Centre of PharmacoVigilance and Pharmacoepidemiology, Faculty of Medicine, Toulouse University Hospital (CHU), 37 Allées Jules Guesde, 31000, Toulouse, France.
Department of Child and Adolescent Psychiatry, Faculty of Medicine, Toulouse University Hospital (CHU), Toulouse, France.
Drug Saf. 2020 Dec;43(12):1315-1322. doi: 10.1007/s40264-020-01013-3. Epub 2020 Oct 19.
In the stressful context of the coronavirus disease 2019 (COVID-19) pandemic, some reports have raised concerns regarding psychiatric disorders with the use of hydroxychloroquine. In this study, we reviewed all psychiatric adverse effects with hydroxychloroquine in COVID-19 patients, as well as in other indications, reported in VigiBase, the World Health Organization's (WHO) global database of individual case safety reports.
First, we analyzed all psychiatric adverse effects, including suicide, of hydroxychloroquine in COVID-19 patients reported to 16 June 2020. We also performed disproportionality analysis to investigate the risk of reporting psychiatric disorders with hydroxychloroquine compared with remdesivir, tocilizumab, or lopinavir/ritonavir prescribed in COVID-19 patients. We used reporting odds ratios (RORs) and their 95% confidence intervals (CIs) to calculate disproportionality. Second, we sought to examine the psychiatric safety profile of hydroxychloroquine in other indications (before 2020).
Among the 1754 reports with hydroxychloroquine in COVID-19 patients, we found 56 psychiatric adverse effects. Half of these adverse effects were serious, including four completed suicides, three cases of intentional self-injury, and 12 cases of psychotic disorders with hallucinations. Compared with remdesivir, tocilizumab, or lopinavir/ritonavir, the use of hydroxychloroquine was associated with an increased risk of reporting psychiatric disorders (ROR 6.27, 95% CI 2.74-14.35). Before 2020, suicide was the main cause of death among all adverse drug reactions reported with hydroxychloroquine, followed by cardiac adverse effects (cardiomyopathy) and respiratory failure.
This pharmacovigilance analysis suggests that COVID-19 patients exposed to hydroxychloroquine experienced serious psychiatric disorders, and, among these patients, some committed suicide. Further real-world studies are needed to quantify the psychiatric risk associated with hydroxychloroquine during the COVID-19 pandemic.
在 2019 年冠状病毒病（COVID-19）大流行的紧张环境下，一些报告引起了人们对使用羟氯喹的精神疾病的关注。在这项研究中，我们审查了 VigiBase 中报告的 COVID-19 患者以及其他适应症中使用羟氯喹的所有精神科不良影响，VigiBase 是世界卫生组织（WHO）的全球个体病例安全报告数据库。
首先，我们分析了截至 2020 年 6 月 16 日报告的 COVID-19 患者使用羟氯喹的所有精神科不良影响，包括自杀。我们还进行了比例失调分析，以调查与 COVID-19 患者开处方的瑞德西韦、托珠单抗或洛匹那韦/利托那韦相比，报告精神障碍的羟氯喹风险。我们使用报告比值比（ROR）及其 95％置信区间（CI）来计算比例失调。其次，我们试图检查羟氯喹在其他适应症（2020 年之前）的精神科安全性概况。
在 COVID-19 患者使用羟氯喹的 1754 份报告中，我们发现了 56 种精神科不良影响。其中一半是严重的，包括四起自杀死亡，三起故意自残和 12 起有幻觉的精神病障碍。与瑞德西韦，托珠单抗或洛匹那韦/利托那韦相比，使用羟氯喹与报告精神障碍的风险增加相关（ROR 6.27，95％CI 2.74-14.35）。在 2020 年之前，自杀是报告的所有与羟氯喹有关的药物不良反应中的主要死因，其次是心脏不良反应（心肌病）和呼吸衰竭。
这项药物警戒分析表明，暴露于羟氯喹的 COVID-19 患者经历了严重的精神科疾病，其中一些患者自杀。需要进一步的真实世界研究来量化 COVID-19 大流行期间与羟氯喹相关的精神科风险。
