Torsade de pointes associated with chloroquine, hydroxychloroquine, and azithromycin: a retrospective analysis of individual case safety reports from VigiBase.
Eur J Clin Pharmacol
; 77(10): 1513-1521, 2021 Oct.
Article
in English
| MEDLINE | ID: covidwho-1813653
ABSTRACT
PURPOSE:
To analyze the cases of torsade de pointes (TdP) and related symptoms reported in association with chloroquine (CQ), hydroxychloroquine (HCQ), and azithromycin (AZT) to the World Health Organization (WHO) global database of individual case safety reports (ICSRs) for drug monitoring (VigiBase) using qualitative and quantitative pharmacovigilance approaches.METHODS:
The main characteristics of the ICSRs reporting TdP with CQ, HCQ, and AZT have been summarized. Co-reported drugs with risk to cause QT prolongation have been described. Reporting odds ratios (RORs) as a measure of disproportionality for reported TdP and individual drugs have been calculated.RESULTS:
One hundred seventy ICSRs reporting TdP in association with the drugs of interest were identified (CQ 11, HCQ 31, CQ + HCQ 1, HCQ + AZT 27, AZT 100). From these, 41 (24.3%) were received during the pandemic period (December 2019 to February 2021). The median age of the patients was 63, 53, and 63 years old for CQ, HCQ, and AZT, respectively. Reports included concomitant use of other QT-prolonging drugs (CQ 25.0%, HCQ 71.2%, AZT 64.6%). A proportion of the cases were fatal (CQ 25.0%, HCQ 8.6%, AZT 16.1%). Increased disproportionality has been found for the individual drugs and TdP CQ (ROR 7.41, 95% confidence interval (CI) 3.82, 12.96), HCQ (ROR 8.49, 95% CI 6.57, 10.98), azithromycin (ROR 8.06, 95% CI 6.76, 9.61). Disproportionality was also found for other related symptoms, Standardized MedDRA Query for torsade de pointes/QT prolongation (narrow) CQ (ROR 11.95, 95% CI 10.04-14.22); HCQ (ROR 20.43, 95% CI 19.13, 21.83), AZT (ROR 7.78, 95% CI 7.26, 8.34).CONCLUSIONS:
The prescription of CQ, HCQ, and AZT should be restricted to therapeutic indications with established positive benefit/risk profile. Doctors and patients should be aware of this potential adverse reaction especially when several risk factors are present.Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Chloroquine
/
Torsades de Pointes
/
Azithromycin
/
Hydroxychloroquine
Type of study:
Observational study
/
Prognostic study
/
Qualitative research
Limits:
Adult
/
Aged
/
Female
/
Humans
/
Male
/
Middle aged
Language:
English
Journal:
Eur J Clin Pharmacol
Year:
2021
Document Type:
Article
Affiliation country:
S00228-021-03133-w
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