Safety profile of chloroquine and hydroxychloroquine: an analysis of the
FDA Adverse Event Reporting System (FAERS) database
Abstract
Aim: CQ and HCQ are currently being investigated worldwide for their
clinical efficacy against COVID-19, however a major concern regarding
these drugs remains their safety profile. The aim of the present study
was to identify potential safety signals of CQ and HCQ use, in the
period prior to their repurpose as COVID-19 treatment options analyzing
safety data retrieved from the FDA Adverse Event Reporting System
(FAERS) pharmacovigilance database. Methods: We performed a
disproportionality analysis of all available 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 reporting
mortality of CQ and HCQ was also investigated Results: The dataset
contained 6,635,356 reports. Based on the comparison of the RORs,
significant differences were observed between CQ and HCQ for most of the
adverse events: cardiomyopathy, cardiac arrhythmias, retinal disorders,
corneal disorders, hearing disorders, headache, hepatic disorders,
severe cutaneous reactions, musculoskeletal disorders and cytopenia.
Only CQ was significantly associated with psychotic disorders, suicide
and self-injury, convulsions, peripheral neuropathy and decreased
appetite. In multivariable logistic regression, outcome death was more
frequently associated with CQ users, generally older females, with
co-reported suicide and self-injury, cardiomyopathy, cardiac arrhythmias
and decreased appetite. Discussion: Our results suggest that HCQ has a
safer clinical profile compared to CQ, especially regarding
cardiotoxicity and thus could serve as a safer therapeutic approach in
COVID-19. However, until more real-world and RCTs’ data are available,
close supervision is strongly recommended.