Abstract
Aim. To compare the cases reported to the Spanish
Pharmacovigilance System (SEFV-H) with HCQ used in COVID-19 vs. HCQ used
in other indications.
Methods. All cases of adverse drug reactions (ADR) submitted to
the Spanish Pharmacovigilance database (FEDRA) from 1 January 1982 to 19
February 2021 suspected to be induced by HCQ were identified. Cases were
classified into two groups: no-Covid patients and Covid patients.
Frequencies of ADR were compared. Reporting Odds Ratios (ROR) with its
lower limit of the 95% confidence interval (-ROR) and Omega (Ω) and its
lower limit of the 95% credibility interval (Ω -025)
were obtained to estimate disproportionalities.
Results. More severe cases were reported with the use of HCQ in
Covid. Main differences in frequency were observed in hepatobiliary,
skin, gastrointestinal, eye, nervous system and heart ADRs. During the
Covid-19 pandemic, disproportionality 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 ischaemic colitis, 8.9 (2.6). Myopathies, haemolytic disorders
and suicidal behaviour increased their disproportionality during the
pandemic. Disproportionality was observed for neoplasms, haematopoietic
cytopaenias and interstitial lung disease in the pre-Covid period. Ω
showed potential interactions between HCQ and azithromycin, ceftriaxone,
lopinavir and tocilizumab.
Conclusions. The use of HCQ in Covid-19 changed its safety
profile. Of particular concern during the pandemic were arrhythmias,
hepatotoxicity, severe skin reactions and suicide risk, but not ocular
disorders. Some ADRs identified as signals would require more detailed
analyses.