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. 2020 Jul 21;142(3):303-305.
doi: 10.1161/CIRCULATIONAHA.120.048238. Epub 2020 May 22.

Cardiovascular Toxicities Associated With Hydroxychloroquine and Azithromycin: An Analysis of the World Health Organization Pharmacovigilance Database

Lee S Nguyen  1   2 , Charles Dolladille  3 , Milou-Daniel Drici  4 , Charlotte Fenioux  1 , Joachim Alexandre  3 , Jean-Paul Mira  5 , Javid J Moslehi  6 , Dan M Roden  6   7 , Christian Funck-Brentano  1 , Joe-Elie Salem  1   6
Affiliations

Cardiovascular Toxicities Associated With Hydroxychloroquine and Azithromycin: An Analysis of the World Health Organization Pharmacovigilance Database

Lee S Nguyen et al. Circulation. .
No abstract available

Keywords: azithromycin; cardiotoxicity; hydroxychloroquine; phamacovigilance.

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Figures

Figure.
Figure.
Temporal evolution (last accessed March 1, 2020) of the information component (IC) for cardiovascular (CV) adverse drug reactions (ADR) significantly associated with hydroxychloroquine or azithromycin (see statistics below). Whiskers are IC025, IC975. IC025 and IC975 are the lower and upper end of the IC 95% credibility interval, respectively. Significance is IC025>0 (black line). LQT, long QT syndrome; TdP/VT, ventricular tachyarrhythmias (VT) including Torsades-de-Pointes (TdP). Years of first ADR report within VigiBase for hydroxychloroquine and azithromycin were respectively 1967 and 1989 (A). Intersection for selected CV-ADR (IC025>0) in case reports from VigiBase, for hydroxychloroquine (B) and azithromycin (C). Time to onset (in days) between first treatment intake and the CV-ADR associated with hydroxychloroquine or azithromycin (D). *Of the conduction disorders (n=75), 50/75 (67%) were atrioventricular blocks, 24/75 (32%) were bundle-branch blocks, and 1/75 (1%) was a sinus block. Time to onset data are available for hydroxychloroquine and LQT and/or TdP/VT (n=90), for hydroxychloroquine and conduction disorders (n=77), for hydroxychloroquine and heart failure (n=94), and for azithromycin and LQT and/or TdP/VT (n=70). Statistics:2 IC = log2[(Nobserved + 0.5)/(Nexpected + 0.5)], where Nexpected = (Ndrug × Nreaction)/Ntotal, with Nexpected being the number of individual case safety reports (ICSRs) expected for the drug-ADR combination; Nobserved being the actual number of ICSRs observed for the drug-ADR combination; Ndrug being the number of ICSRs for the drug, regardless of ADR; Nreaction being the number of ICSRs for the ADR, regardless of the drug; and Ntotal being the total number of ICSRs in the database.
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References

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