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Psychiatric Disorders and Hydroxychloroquine for Coronavirus Disease 2019 (COVID-19): A VigiBase Study
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Psychiatric Disorders and Hydroxychloroquine for Coronavirus Disease 2019 (COVID-19): A VigiBase Study
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Psychiatric Disorders and Hydroxychloroquine for Coronavirus Disease 2019 (COVID-19): A VigiBase Study
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Journal Article
Psychiatric Disorders and Hydroxychloroquine for Coronavirus Disease 2019 (COVID-19): A VigiBase Study
2020
Overview
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.
Publisher
Springer International Publishing,Springer Nature B.V,Springer Verlag
Subject
Adenosine Monophosphate / adverse effects
/ Adenosine Monophosphate / analogs & derivatives
/ Adult
/ Age
/ Aged
/ Alanine / analogs & derivatives
/ Antibodies, Monoclonal, Humanized / adverse effects
/ Antiviral Agents / adverse effects
/ Anxiety
/ COVID-19
/ Disease
/ Drug Safety and Pharmacovigilance
/ Drugs
/ Female
/ Hallucinations / chemically induced
/ Hallucinations / epidemiology
/ Humans
/ Hydroxychloroquine / adverse effects
/ Insomnia
/ Lupus
/ Male
/ Medicine
/ Original
/ Patients
/ Safety
/ Santé publique et épidémiologie
/ Severe acute respiratory syndrome coronavirus 2
/ Suicide
