Identification of Bradycardia Following Remdesivir Administration Through the US Food and Drug Administration American College of Medical Toxicology COVID-19 Toxic Pharmacovigilance Project.

ABSTRACT:

Importance

The rapid spread and mortality associated with COVID-19 emphasized a need for surveillance system development to identify adverse events (AEs) to emerging therapeutics. Bradycardia is a remdesivir infusion-associated AE listed in the US Food and Drug Administration-approved prescribing information.

Objective

To evaluate the magnitude and duration of bradycardic events following remdesivir administration.

Design, setting, and participants

A multicenter cohort study of patients with recorded heart rate less than 60 beats per minute within 24 hours after administration of a remdesivir dose was conducted between November 23, 2020, and October 31, 2021. Participants included patients hospitalized with COVID-19 at 15 medical centers across the US. Patients exclud

SUBMITTER: Devgun JM 

PROVIDER: S-EPMC9929701 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature