Affiliations 

  • 1 Department of Pharmacology, All India Institute of Medical Sciences , Jodhpur, India
  • 2 Department of Pharmacology, S.N. Medical College , Jodhpur, India
  • 3 Department of Community and Family Medicine, All India Institute of Medical Sciences , Jodhpur, India
  • 4 Unit of Pharmacology, Faculty of Medicine and Defence Health, Universiti Pertahanan Nasional Malaysia (National Defence University of Malaysia) , Kuala Lumpur, Malaysia
  • 5 Department of Biochemistry, All India Institute of Medical Sciences , Jodhpur, India
  • 6 Department of Surgical Oncology, All India Institute of Medical Sciences , Jodhpur, India
  • 7 Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde , Glasgow, UK
Expert Rev Clin Pharmacol, 2021 Jan;14(1):95-103.
PMID: 33252992 DOI: 10.1080/17512433.2021.1856655

Abstract

Objectives: Remdesivir has shown promise in the management of patients with COVID-19 although recent studies have shown concerns with its effectiveness in practice. Despite this there is a need to document potential adverse drug events (ADEs) to guide future decisions as limited ADE data available before the COVID-19 pandemic. Methods: Interrogation of WHO VigiBase® from 2015 to 2020 coupled with published studies of ADEs in COVID-19 patients. The main outcome measures are the extent of ADEs broken down by factors including age, seriousness, region and organ. Results: A total 1086 ADEs were reported from the 439 individual case reports up to July 19, 2020, in the VigiBase®, reduced to 1004 once duplicates were excluded. Almost all ADEs concerned COVID-19 patients (92.5%), with an appreciable number from the Americas (67.7%). The majority of ADEs were from males > 45 years and were serious (82.5%). An increase in hepatic enzymes (32.1%), renal injury (14.4%), rise in creatinine levels (11.2%), and respiratory failure (6.4%) were the most frequently reported ADEs. Conclusions: Deterioration of liver and kidney function are frequently observed ADEs with remdesivir; consequently, patients should be monitored for these ADEs. The findings are in line with ADEs included in regulatory authority documents.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.