Safety profile of chloroquine and hydroxychloroquine: a disproportionality analysis of the FDA Adverse Event Reporting System database.
Eur Rev Med Pharmacol Sci
; 25(19): 6003-6012, 2021 Oct.
Article
in English
| MEDLINE | ID: covidwho-1478938
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 ANDMETHODS:
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:
Our results confirm previously 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.
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
United States Food and Drug Administration
/
Chloroquine
/
Adverse Drug Reaction Reporting Systems
/
Hydroxychloroquine
Type of study:
Prognostic study
/
Randomized controlled trials
Limits:
Humans
/
Male
/
Middle aged
Country/Region as subject:
North America
Language:
English
Journal:
Eur Rev Med Pharmacol Sci
Journal subject:
Pharmacology
/
Toxicology
Year:
2021
Document Type:
Article
Affiliation country:
Eurrev_202110_26878
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