Hepatobiliary Adverse Drug Reactions Associated With Remdesivir: The WHO International Pharmacovigilance Study.

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 hepato...

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Authors: Kim MS; Jung SY; Lee SW; Li H; Koyanagi A; Kronbichler A; Dragioti E; Tizaoui K; Wasuwanich P; Hong SH; Ghayda RA; Yoo HW; Kim H; Jacob L; Salem JE; Kostev K; Shin YH; Kim SY; Gamerith G; Yon DK; Shin JI; Smith L
Format: Article
Status:Published version
Publication date:2021
Country:España
Institution:Fundació Sant Joan de Déu
Repository:r-FSJD. Repositorio Institucional de Producción Científica de la Fundació Sant Joan de Déu
OAI Identifier:oai:fsjd.fundanetsuite.com:p19523
Online Access:https://fsjd.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=19523
Access Level:Open access
Summary: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.

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