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

Anthony Touafchia1, Haleh Bagheri2, Didier Carrié3

  • 1Department of Medical and Clinical Pharmacology, Centre of PharmacoVigilance and Pharmacoepidemiology, Toulouse University Hospital (CHU), Faculty of Medicine, Toulouse, France; Department of Cardiology, Toulouse University Hospital (CHU), Faculty of Medicine, Toulouse, France.

Clinical Microbiology and Infection : the Official Publication of the European Society of Clinical Microbiology and Infectious Diseases
|March 1, 2021
PubMed

Insights

Remdesivir use in COVID-19 patients was linked to a higher risk of bradycardia, a slow heart rate. This safety concern warrants further investigation into remdesivir

Area of Science:

  • Pharmacovigilance
  • Infectious Diseases
  • Cardiology

Background:

  • Cardiac arrhythmias have been reported with remdesivir treatment for COVID-19.
  • A safety concern exists regarding the potential for remdesivir to cause bradycardia.

Purpose of the Study:

  • To investigate the association between remdesivir use and an increased risk of bradycardia in COVID-19 patients.
  • To compare bradycardia reporting rates in remdesivir-exposed patients with those on other COVID-19 treatments.

Main Methods:

  • Utilized VigiBase®, the WHO Global Individual Case Safety Reports database.
  • Conducted disproportionality analyses comparing remdesivir with hydroxychloroquine, lopinavir/ritonavir, tocilizumab, or glucocorticoids.
  • Included COVID-19 patient reports registered up to September 23, 2020.

Main Results:

  • Identified 94 bradycardia cases (31%) among 2603 remdesivir reports for COVID-19.
  • Found a significantly increased risk of bradycardia reporting with remdesivir (ROR 1.65; 95% CI 1.23-2.22) compared to other treatments.
  • 80% of bradycardia reports were serious, with 17% resulting in fatalities.

Conclusions:

  • Remdesivir use in a real-world setting is significantly associated with an increased risk of bradycardia.
  • The findings align with the known pharmacodynamic properties of remdesivir.
  • This suggests a need for careful monitoring of cardiac function in patients treated with remdesivir.
Abstract

Keywords:
BradycardiaCOVID-19PharmacovigilanceRNA-dependent RNA-polymerase inhibitorsRemdesivirVigibase

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