TY - JOUR
AU - Charan, Jaykaran
AU - Kaur, Rimple Jeet
AU - Bhardwaj, Pankaj
AU - Haque, Mainul
AU - Sharma, Praveen
AU - Misra, Sanjeev
AU - Godman, Brian
PY - 2021
DA - January
TI - Rapid review of suspected adverse drug events due to remdesivir in the WHO database; findings and implications
JO - Expert Review of Clinical Pharmacology
EP - 103
VL - 14
IS - 1
DO - https://doi.org/10.1080/17512433.2021.1856655
AB - 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 &gt; 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.
PB - Taylor and Francis
UR - https://pureportal.strath.ac.uk/en/publications/rapid-review-of-suspected-adverse-drug-events-due-to-remdesivir-i
KW - Coronavirus (COVID-19)
ER