Cardiovascular events and safety outcomes associated with remdesivir using a World Health Organization international pharmacovigilance database.
Clin Transl Sci
; 15(2): 501-513, 2022 02.
Article
in English
| MEDLINE | ID: covidwho-1494654
ABSTRACT
On October 2020, the US Food and Drug Administration (FDA) approved remdesivir as the first drug for the treatment of coronavirus disease 2019 (COVID-19), increasing remdesivir prescriptions worldwide. However, potential cardiovascular (CV) toxicities associated with remdesivir remain unknown. We aimed to characterize the CV adverse drug reactions (ADRs) associated with remdesivir using VigiBase, an individual case safety report database of the World Health Organization (WHO). Disproportionality analyses of CV-ADRs associated with remdesivir were performed using reported odds ratios and information components. We conducted in vitro experiments using cardiomyocytes derived from human pluripotent stem cell cardiomyocytes (hPSC-CMs) to confirm cardiotoxicity of remdesivir. To distinguish drug-induced CV-ADRs from COVID-19 effects, we restricted analyses to patients with COVID-19 and found that, after adjusting for multiple confounders, cardiac arrest (adjusted odds ratio [aOR] 1.88, 95% confidence interval [CI] 1.08-3.29), bradycardia (aOR 2.09, 95% CI 1.24-3.53), and hypotension (aOR 1.67, 95% CI 1.03-2.73) were associated with remdesivir. In vitro data demonstrated that remdesivir reduced the cell viability of hPSC-CMs in time- and dose-dependent manners. Physicians should be aware of potential CV consequences following remdesivir use and implement adequate CV monitoring to maintain a tolerable safety margin.
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Antiviral Agents
/
Cardiovascular Diseases
/
Adenosine Monophosphate
/
Alanine
/
Pharmacovigilance
/
SARS-CoV-2
/
COVID-19 Drug Treatment
Type of study:
Observational study
/
Prognostic study
Limits:
Humans
Language:
English
Journal:
Clin Transl Sci
Year:
2022
Document Type:
Article
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