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

Journal: Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association

Volume: 19

Issue: 9

Year of Publication: 2021

Affiliated Institutions:  College of Medicine, Korea University, Seoul, Republic of Korea; Genomics and Digital Health, Samsung Advanced Institute for Health Sciences and Technology, Sungkyunkwan University, Seoul, Republic of Korea. Department of Pediatrics, Yonsei University College of Medicine, Seoul, Republic of Korea. Department of Data Science, Sejong University College of Software Convergence, Seoul, Republic of Korea. University of Florida College of Medicine, Gainesville, Florida. Research and Development Unit, Parc Sanitari Sant Joan de Déu, Universitat de Barcelona, Fundació Sant Joan de Déu, CIBERSAM, Barcelona, Spain; ICREA, Pg. Lluis Companys , Barcelona, Spain; Instituto de Salud Carlos III, Centro de Investigación Biomédica en Red de Salud Mental, CIBERSAM, Madrid, Spain. Department of Internal Medicine IV, Medical University Innsbruck, Innsbruck, Austria. Pain and Rehabilitation Centre, Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden. Laboratory Microorganismes and Active Biomolecules, Sciences Faculty of Tunis, University Tunis El Manar, Tunis, Tunisia. Yonsei University College of Medicine, Seoul, Republic of Korea. Urology Institute, University Hospitals System, Case Western Reserve University School of Medicine, Cleveland, Ohio. Division of Gastroenterology and Hepatology, Soon Chun Hyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon, Republic of Korea. College of Medicine, Ewha Womans University, Seoul, Republic of Korea. Research and Development Unit, Parc Sanitari Sant Joan de Déu, Universitat de Barcelona, Fundació Sant Joan de Déu, CIBERSAM, Barcelona, Spain; Faculty of Medicine, University of Versailles Saint-Quentin-en-Yvelines, Montigny-le-Bretonneux, France. Sorbonne Université, INSERM, CIC- Paris-Est, CLIP() Galilée, UNICO-GRECO Cardio-oncology Program, and Department of Pharmacology, Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France. University Clinic of Marburg, Marburg, Germany. Department of Pediatrics, CHA Gangnam Medical Center, CHA University School of Medicine, Seoul, Republic of Korea. Department of Otorhinolaryngology-Head & Neck Surgery, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam, Republic of Korea. Internal Medicine V, Department of Hematology and Oncology, Medical University Innsbruck, Innsbruck, Austria. Department of Pediatrics, Seoul National University Children's Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea. Electronic address: yonkkang@gmail.com. Department of Pediatrics, Yonsei University College of Medicine, Seoul, Republic of Korea. Electronic address: shinji@yuhs.ac. The Cambridge Centre for Sport and Exercise Sciences, Anglia Ruskin University, Cambridge, United Kingdom.

Abstract summary 

Remdesivir has demonstrated clinical benefits in randomized placebo-controlled trials (RCTs) in patients with coronavirus disease 2019 (COVID-19) and was first approved for COVID-19 patients. However, whether remdesivir causes gastrointestinal adverse drug reaction (GI-ADRs) including hepatotoxicity is less clear. 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.

Authors & Co-authors:  Kim Min Seo MS Jung Se Yong SY Lee Seung Won SW Li Han H Koyanagi Ai A Kronbichler Andreas A Dragioti Elena E Tizaoui Kalthoum K Wasuwanich Paul P Hong Sung Hwi SH Ghayda Ramy Abou RA Yoo Hae Won HW Kim Hanna H Jacob Louis L Salem Joe-Elie JE Kostev Karel K Shin Youn Ho YH Kim So Young SY Gamerith Gabriele G Yon Dong Keon DK Shin Jae Il JI Smith Lee L

Study Outcome 

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Statistics
Citations : 
Authors :  22
Identifiers
Doi : 10.1016/j.cgh.2021.04.039
SSN : 1542-7714
Study Population
Male,Female
Mesh Terms
Adenosine Monophosphate
Other Terms
Study Design
Randomized Control Trial,Case Study,Cross Sectional Study
Study Approach
Country of Study
Publication Country
United States