Hydroxychloroquine-related psychiatric disorders in COVID-19 patients

Treatment with hydroxychloroquine (HCQ) in patients with COVID-19 appears to be associated with an increased risk of psychiatric disorders and suicide, according to findings of a study published in Drug Safety.

Data from VigiBase, the WHO's global database of individual case safety reports (ICSRs), were used to investigate psychiatric adverse events including suicide reported between January 2020 and 16 June 2020 in patients with COVID-19 receiving HCQ. Disproportionality analysis was used to evaluate reporting odds ratios (RORs) for psychiatric disorders in COVID-19 patients prescribed HCQ versus remdesivir, tocilizumab, or lopinavir/ritonavir. In secondary analysis, HCQ-related adverse events reported in all adults between 1983 and 2019 were reviewed.

During the study period, 56 psychiatric adverse events were reported in 1754 ICSRs in COVID-19 patients receiving HCQ; 50% of cases reported serious psychiatric disorders including psychotic disorders with hallucinations, agitation or aggression (12 cases), insomnia or anxiety (7), suicide (4), self-injury (3) and confusion (2). HCQ was the sole suspected drug in all cases of suicide. Non-serious cases included anxiety, depression and sleep disorders.

Use of HCQ was associated with an increased risk of psychiatric disorders compared with remdesivir, tocilizumab, or lopinavir/ritonavir (ROR 6.27; 95% CI 2.74, 14.35).

Prior to 2020, the most frequently reported causes of death in ICSRs reported in patients receiving HCQ were suicide (48 cases), cardiomyopathy and respiratory failure.

"The risk of psychiatric disorders with hydroxychloroquine is probably a rare adverse drug reaction, but could be serious as several cases of completed suicide were reported. Given the paucity of evidence of benefit in COVID-19, as well as this signal of psychiatric risk, there is no reason to prescribe hydroxychloroquine for treating COVID-19 patients in routine practice," concluded the authors.