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“Off-label” use of hydroxychloroquine, azithromycin, lopinavir-ritonavir and chloroquine in COVID-19: A survey of cardiac adverse drug reactions by the French Network of Pharmacovigilance Centers - 20/08/20

Doi : 10.1016/j.therap.2020.05.002 
Alexandre Gérard a, 1, Serena Romani a, 1, Audrey Fresse a, Delphine Viard a, Nadège Parassol a, Aurélie Granvuillemin b, Laurent Chouchana c, Fanny Rocher a, Milou-Daniel Drici a,
the

French Network of Pharmacovigilance Centers

a Pharmacovigilance, department of pharmacology, Pasteur hospital, Bât J4, 30, avenue de la Voie-Romaine, CS51069, 06001 Nice Cedex 01, France 
b Centre régional de pharmacovigilance, 21079 Dijon, France 
c Centre régional de pharmacovigilance Paris-Cochin, 75014 Paris, France 

Corresponding author.

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Summary

Introduction

COVID-19 is an unprecedented challenge for physicians and scientists. Several publicized drugs are being used with not much evidence of their efficacy such as hydroxychloroquine, azithromycin or lopinavir-ritonavir. Yet, the cardiac safety of these drugs in COVID-19 deserves scrutiny as they are known to foster cardiac adverse ADRs, notably QTc interval prolongation on the electrocardiogram and its arrhythmogenic consequences.

Methods

Since March 27th, 2020, the French Pharmacovigilance Network directed all cardiac adverse drug reactions associated with “off-label” use of hydroxychloroquine, azithromycin and lopinavir-ritonavir in COVID-19 to the Nice Regional Center of Pharmacovigilance. Each Regional Center of Pharmacovigilance first assessed causality of drugs. We performed a specific analysis of these cardiac adverse drug reactions amidst an array of risk factors, reassessed the electrocardiograms and estimated their incidence in coronavirus disease 2019.

Results

In one month, 120 reports of cardiac adverse drug reactions have been notified, 103 of which associated with hydroxychloroquine alone (86%), or associated with azithromycin (60%). Their estimated incidence is 0.77% to 1.54% of all patients, notwithstanding strong underreporting. Lopinavir-ritonavir came third with 17 reports (14%) and chloroquine fourth with 3 reports (2.5%). There were 8 sudden, unexplained or aborted deaths (7%), 8 ventricular arrhythmias (7%), 90 reports of prolonged QTc (75%) most of them “serious” (64%), 48 of which proved ≥ 500ms, 20 reports of severe conduction disorders (17%) and 5 reports of other cardiac causes (4%). Six reports derived from automedication.

Discussion and conclusion

“Off-label” use of treatments in COVID-19 increases the risk of cardiac ADRs, some of them avoidable. Even if these drugs are perceived as familiar, they are used in patients with added risk factors caused by infection. Precautions should be taken to mitigate the risk, even if they will be proven efficacious.

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Keywords : Hydroxychloroquine, Azithromycin, Lopinavir, Cardiac adverse effects, QTc prolongation, Arrhythmia, COVID-19


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© 2020  Société française de pharmacologie et de thérapeutique. Publicado por Elsevier Masson SAS. Todos los derechos reservados.
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Vol 75 - N° 4

P. 371-379 - juillet 2020 Regresar al número
Artículo precedente Artículo precedente
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