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. 2021 Feb 27;27(5):791.e5-791.e8.
doi: 10.1016/j.cmi.2021.02.013. Online ahead of print.

Serious bradycardia and remdesivir for coronavirus 2019 (COVID-19): a new safety concerns

Anthony Touafchia  1 , Haleh Bagheri  2 , Didier Carrié  3 , Geneviève Durrieu  2 , Agnès Sommet  2 , Laurent Chouchana  4 , François Montastruc  5
Affiliations

Serious bradycardia and remdesivir for coronavirus 2019 (COVID-19): a new safety concerns

Anthony Touafchia et al. Clin Microbiol Infect. .

Abstract

Objectives: In recent clinical trials some cardiac arrhythmias were reported with use of remdesivir for COVID-19. To address this safety concern, we investigated whether use of remdesivir for COVID-19 is associated with an increased risk of bradycardia.

Methods: Using VigiBase®, the World Health Organization Global Individual Case Safety Reports database, we compared the cases of bradycardia reported in COVID-19 patients exposed to remdesivir with those reported in COVID-19 patients exposed to hydroxychloroquine, lopinavir/ritonavir, tocilizumab or glucocorticoids. All reports of patients with COVID-19 registered up to the 23 September 2020 were included. We conducted disproportionality analyses allowing the estimation of reporting odds ratios (RORs) with 95% CI.

Results: We found 302 cardiac effects including 94 bradycardia (31%) among the 2603 reports with remdesivir prescribed in COVID-19 patients. Most of the 94 reports were serious (75, 80%), and in 16 reports (17%) evolution was fatal. Compared with hydroxychloroquine, lopinavir/ritonavir, tocilizumab or glucocorticoids, the use of remdesivir was associated with an increased risk of reporting bradycardia (ROR 1.65; 95% CI 1.23-2.22). Consistent results were observed in other sensitivity analyses.

Discussion: This post-marketing study in a real-world setting suggests that the use of remdesivir is significantly associated with an increased risk of reporting bradycardia and serious bradycardia when compared with the use of with hydroxychloroquine, lopinavir/ritonavir, tocilizumab or glucocorticoids. This result is in line with the pharmacodynamic properties of remdesivir.

Keywords: Bradycardia; COVID-19; Pharmacovigilance; RNA-dependent RNA-polymerase inhibitors; Remdesivir; Vigibase.

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