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


Por: 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 and Smith L

Publicada: 1 sep 2021 Ahead of Print: 30 abr 2021
Resumen:
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.

Filiaciones:
Kim MS:
 Korea University, College of Medicine, Seoul, Republic of Korea

 Genomics and Digital Health, Samsung Advanced Institute for Health Sciences and Technology (SAIHST), Sungkyunkwan University, Seoul, Republic of Korea

Jung SY:
 Division of Pediatric Cardiology, Department of Pediatrics, Yonsei University College of Medicine, Seoul, Republic of Korea

Lee SW:
 Department of Data Science, Sejong University College of Software Convergence, Seoul, Republic of Kore

Li H:
 University of Florida College of Medicine, Gainesville, FL 32610, USA

Koyanagi A:
 Research and Development Unit, Parc Sanitari Sant Joan de Déu, Universitat de Barcelona, Fundació Sant Joan de Déu, CIBERSAM, 08830 Barcelona, Spain

 ICREA, Pg. Lluis Companys 23, 08010 Barcelona, Spain

 Instituto de Salud Carlos III, Centro de Investigación Biomédica en Red de Salud Mental, CIBERSAM, 28029 Madrid, Spain

Kronbichler A:
 Department of Internal Medicine IV, Medical University Innsbruck, Anichstraße 35, 6020 Innsbruck, Austria

Dragioti E:
 Pain and Rehabilitation Centre, and Department of Health, Medicine and Caring Sciences, Linköping University, SE-581 85 Linköping, Sweden

Tizaoui K:
 Department of Basic Sciences, Medicine Faculty of Tunis, Tunis El Manar University, 15 Rue Djebel Lakdar, Tunis 1007, Tunisia

Wasuwanich P:
 University of Florida College of Medicine, Gainesville, FL 32610, USA

Hong SH:
 Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, MA 02115, USA

 Yonsei University College of Medicine, Seoul 03722, Republic of Korea

Ghayda RA:
 Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, MA 02115, USA

 Urology Institute, University Hospitals System, Case Western Reserve University School of Medicine, Cleveland, OH, USA

Yoo HW:
 Division of Gastroenterology and Hepatology, Soon Chun Hyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon, Republic of Korea

Kim H:
 College of Medicine, Ewha Womans University, Seoul, Republic of Korea

Jacob L.:
 Research and Development Unit, Parc Sanitari Sant Joan de Déu, Universitat de Barcelona, Fundació Sant Joan de Déu, CIBERSAM, 08830 Barcelona, Spain

 Faculty of Medicine, University of Versailles Saint-Quentin-en-Yvelines, 78180, Montigny-le-Bretonneux, France

Salem JE:
 Sorbonne Université, INSERM, CIC-1901 Paris-Est, CLIP2 Galilée, UNICO-GRECO Cardio-oncology Program, and Department of Pharmacology, Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris, F-75013 Paris, France

Kostev K:
 University Clinic of Marburg, Marburg, Germany

Shin YH:
 Department of Pediatrics, CHA Gangnam Medical Center, CHA University School of Medicine, Seoul, Republic of Korea

Kim SY:
 Department of Otorhinolaryngology-Head & Neck Surgery, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam, Republic of Korea

Gamerith G:
 Internal Medicine V, Department of Hematology and Oncology, Medical University Innsbruck, 6020 Innsbruck, Austria

Yon DK:
 Department of Pediatrics, Seoul National University Children's Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea. Electronic address:

Shin JI:
 Division of Pediatric Cardiology, Department of Pediatrics, Yonsei University College of Medicine, Seoul, Republic of Korea

Smith L:
 The Cambridge Centre for Sport and Exercise Sciences, Anglia Ruskin University, Cambridge CB1 1PT, UK
ISSN: 15423565





Clinical Gastroenterology and Hepatology
Editorial
ELSEVIER SCIENCE INC, STE 800, 230 PARK AVE, NEW YORK, NY 10169, Estados Unidos America
Tipo de documento: Article
Volumen: 19 Número: 9
Páginas: 1970-1970
WOS Id: 000685953000035
ID de PubMed: 33940227
imagen Green Accepted

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