Background: The use of hydroxychloroquine (HCQ) in the first COVID-19 epidemic wave raised safety concerns.
Research design and methods: Adverse reactions (ADR) suspected to be induced by HCQ and submitted to the Spanish Pharmacovigilance Database were studied. A disproportionality analysis was performed to determine adverse effects reported in non-Covid and Covid patients. To explore potential drug-drug interactions, Omega (Ω) statistics was calculated.
Results: More severe cases were reported when used in COVID-19. Main differences in frequency were observed in hepatobiliary, skin, gastrointestinal, eye, nervous system and heart ADRs. During the COVID-19 pandemic, high disproportionality in reports was found for Torsade de Pointes/QT prolongation with a ROR (-ROR) of 132.8 (76.7); severe hepatotoxicity, 18.7 (14.7); dyslipidaemias, 12.1 (6.1); shock, 9.5 (6.9) and ischemic colitis, 8.9 (2.6). Myopathies, hemolytic disorders and suicidal behavior increased their disproportionality during the pandemic. Disproportionality was observed for neoplasms, hematopoietic cytopaenias and interstitial lung disease in the pre-COVID-19 period. Potential interactions were showed between HCQ and azithromycin, ceftriaxone, lopinavir and tocilizumab.
Conclusions: The use of HCQ during the Covid-19 pandemic changed its ADRs reporting profile. Of particular concern during the pandemic were arrhythmias, hepatotoxicity, severe skin reactions and suicide, but not ocular disorders. Some signals identified would require more detailed analyses.
Keywords: Adverse drug reactions; COVID-19; hydroxychloroquine; pharmacovigilance; safety profile.