Safety profile of chloroquine and hydroxychloroquine: A disproportionality analysis of the FDA Adverse Event Reporting System database

G. PAPAZISIS, S. SIAFIS, D. CEPATYTE, D. GIANNIS, E. STAMOULA, D. TZACHANIS, T. EGBERTS

Research output: Contribution to journalArticlepeer-review

5 Scopus citations

Abstract

OBJECTIVE: The present study aims to identify potential safety signals of chloroquine (CQ) and hydroxychloroquine (HCQ), over the period preceding their repurpose as COVID-19 treatment options, through the analysis of safety data retrieved from the FDA Adverse Event Reporting System (FAERS) pharmacovigilance database. MATERIALS AND METHODS: We performed a disproportionality analysis of FAERS data between the first quarter of 2004 and December 2019 using the OpenVigil2.1-MedDRA software. Disproportionality was quantified using the reporting odds ratio (ROR) and its 95% confidence interval (CIs). The reported mortality of CQ and HCQ was also investigated. RESULTS: The dataset contained 6,635,356 reports. Comparison of the RORs revealed significant differences between CQ and HCQ for the following adverse events: Cardiomyopathy, cardiac arrhythmias, retinal disorders, corneal disorders, hearing disorders, headache, hepatic disorders, severe cutaneous reactions, musculoskeletal disorders, and cytopenia. Only CQ was associated with psychotic disorders, suicide, self-injury, convulsions, peripheral neuropathy, and decreased appetite. In multivariable logistic regression, death was more frequently associated with CQ use, advanced age, male sex, co-reported suicide and self-injury, cardiomyopathy, cardiac arrhythmias, and decreased appetite. CONCLUSIONS: O ur r esults c onfirm p reviously published evidence and suggest that HCQ has a safer clinical profile compared to CQ, and thus could serve as the drug of choice for future therapeutic purposes.

Original languageEnglish
Pages (from-to)6003-6012
Number of pages10
JournalEuropean Review for Medical and Pharmacological Sciences
Volume25
Issue number19
DOIs
StatePublished - 2021
Externally publishedYes

Keywords

  • Chloroquine
  • Disproportionality analysis
  • FAERS
  • Hydroxychloroquine
  • Safety

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