Psychiatric Disorders and Hydroxychloroquine for Coronavirus Disease 2019 (COVID-19): A VigiBase Study.
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.
|投稿者||Garcia, Philippe; Revet, Alexis; Yrondi, Antoine; Rousseau, Vanessa; Degboe, Yannick; Montastruc, Francois|
|組織名||Department of Medical and Clinical Pharmacology, Centre of PharmacoVigilance and;Pharmacoepidemiology, Faculty of Medicine, Toulouse University Hospital (CHU), 37;Allees Jules Guesde, 31000, Toulouse, France.;Department of Child and Adolescent Psychiatry, Faculty of Medicine, Toulouse;University Hospital (CHU), Toulouse, France.;UMR 1027 Pharmacoepidemiology, Assessment of Drug Utilization and Drug Safety,;INSERM, CIC 1426, University Paul Sabatier Toulouse, Toulouse, France.;Department of Medical Psychiatry, Toulouse University Hospital (CHU), Faculty of;Medicine, Treatment Resistant Depression Expert Center, FondaMental, ToNIC;Toulouse NeuroImaging Center, University Paul Sabatier Toulouse, INSERM,;Toulouse, France.;Department of Rheumatology, Faculty of Medicine, Toulouse University Hospital;(CHU), Toulouse, France.;Allees Jules Guesde, 31000, Toulouse, France. firstname.lastname@example.org.;email@example.com.|