Psychiatric Disorders and Hydroxychloroquine for Coronavirus Disease 2019 (COVID-19): A VigiBase Study
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ORIGINAL RESEARCH ARTICLE
Psychiatric Disorders and Hydroxychloroquine for Coronavirus Disease 2019 (COVID‑19): A VigiBase Study Philippe Garcia1 · Alexis Revet2,3 · Antoine Yrondi4 · Vanessa Rousseau1,3 · Yannick Degboe5 · François Montastruc1,3 Accepted: 30 September 2020 © Springer Nature Switzerland AG 2020
Abstract Introduction 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. Methods 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). Results 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. Conclusions 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. * François Montastruc francois.montastruc@univ‑tlse3.fr 1
Key Points
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
The use of hydroxychloroquine for coronavirus disease 2019 (COVID-19) patients was associated with an increased risk of reporting psychiatric disorders.
2
Department of Child and Adolescent Psychiatry, Faculty of Medicine, Toulouse University Hospital (CHU), Toulouse, France
3
UMR 1027 Pharmacoepidemiology, Assessment of Drug Utilization and Drug Safety, INSERM, CIC 1426, University P
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