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Hepatobiliary Adverse Drug Reactions Associated With Remdesivir: The WHO International Pharmacovigilance Study.
Kim, Min Seo; Jung, Se Yong; Lee, Seung Won; Li, Han; Koyanagi, Ai; Kronbichler, Andreas; Dragioti, Elena; Tizaoui, Kalthoum; Wasuwanich, Paul; Hong, Sung Hwi; Ghayda, Ramy Abou; Yoo, Hae Won; Kim, Hanna; Jacob, Louis; Salem, Joe-Elie; Kostev, Karel; Shin, Youn Ho; Kim, So Young; Gamerith, Gabriele; Yon, Dong Keon; Shin, Jae Il; Smith, Lee.
  • Kim MS; 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.
  • Jung SY; 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 Korea.
  • Li H; University of Florida College of Medicine, Gainesville, Florida.
  • Koyanagi A; 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 23, Barcelona, Spain; Instituto de Salud Carlos III, Centro de Investigación Biomédica en Red de Salud Mental, CIBERSAM, Madrid, S
  • Kronbichler A; Department of Internal Medicine IV, Medical University Innsbruck, Innsbruck, Austria.
  • Dragioti E; Pain and Rehabilitation Centre, Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden.
  • Tizaoui K; Laboratory Microorganismes and Active Biomolecules, Sciences Faculty of Tunis, University Tunis El Manar, Tunis, Tunisia.
  • Wasuwanich P; University of Florida College of Medicine, Gainesville, Florida.
  • Hong SH; Yonsei University College of Medicine, Seoul, Republic of Korea.
  • Ghayda RA; Urology Institute, University Hospitals System, Case Western Reserve University School of Medicine, Cleveland, Ohio.
  • 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, Barcelona, Spain; Faculty of Medicine, University of Versailles Saint-Quentin-en-Yvelines, Montigny-le-Bretonneux, France.
  • Salem JE; Sorbonne Université, INSERM, CIC-1901 Paris-Est, CLIP(2) Galilée, UNICO-GRECO Cardio-oncology Program, and Department of Pharmacology, Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris, 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, 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: yonkkang@gmail.com.
  • Shin JI; Department of Pediatrics, Yonsei University College of Medicine, Seoul, Republic of Korea. Electronic address: shinji@yuhs.ac.
  • Smith L; The Cambridge Centre for Sport and Exercise Sciences, Anglia Ruskin University, Cambridge, United Kingdom.
Clin Gastroenterol Hepatol ; 19(9): 1970-1972.e3, 2021 09.
Article in English | MEDLINE | ID: covidwho-1212376
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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Drug-Related Side Effects and Adverse Reactions / COVID-19 Drug Treatment Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: Clin Gastroenterol Hepatol Journal subject: Gastroenterology Year: 2021 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Drug-Related Side Effects and Adverse Reactions / COVID-19 Drug Treatment Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: Clin Gastroenterol Hepatol Journal subject: Gastroenterology Year: 2021 Document Type: Article