Hepatobiliary Adverse Drug Reactions Associated With Remdesivir: The WHO International Pharmacovigilance Study
Authors
Min Seo Kim ; Se Yong Jung ; Seung Won Lee ; Han Li ; Ai Koyanagi ; Andreas Kronbichler ; Elena Dragioti ; Kalthoum Tizaoui ; Paul Wasuwanich ; Sung Hwi Hong ; Ramy Abou Ghayda ; Hae Won Yoo ; Hanna Kim ; Louis Jacob ; Joe-Elie Salem ; Karel Kostev ; Youn Ho Shin ; So Young Kim ; Gabriele Gamerith ; Dong Keon Yon ; Jae Il Shin ; Lee Smith
Citation
CLINICAL GASTROENTEROLOGY AND HEPATOLOGY, Vol.19(9) : 1970-1970.e3, 2021-09
Adenosine Monophosphate / analogs & derivatives ; Adverse Drug Reaction Reporting Systems ; Alanine / analogs & derivatives ; COVID-19* / drug therapy ; Databases, Factual ; Drug-Related Side Effects and Adverse Reactions* / epidemiology ; Humans ; Pharmacovigilance ; SARS-CoV-2 ; World Health Organization
Abstract
Remdesivir has demonstrated clinical benefits in randomized placebo-controlled trials (RCTs) in patients with coronavirus disease 2019 (COVID-19)1-4 and was first approved for COVID-19 patients.5 However, whether remdesivir causes gastrointestinal adverse drug reaction (GI-ADRs) including hepatotoxicity is less clear.1-4,6 Therefore, we aimed to detect a diverse spectrum of GI-ADRs associated with remdesivir using VigiBase, the World Health Organization's international pharmacovigilance database of individual case safety reports.