AN EVALUATION OF ADVERSE DRUG REACTIONS WITH REMDESIVIR IN PATIENTS OF COVID-19
DOI:
https://doi.org/10.22159/ajpcr.2022.v15i8.44985Keywords:
Remdesivir, Adverse drug reactions, COVID-19, Causality assessmentAbstract
Objectives: The aim of the study was to evaluate the adverse drug reactions (ADR) following Remdesivir therapy in patients of COVID-19.
Methods: All patients more than 18 years of age of any gender, diagnosed with COVID-19 infection receiving remdesivir therapy and fulfilling the selection criteria were included in the study after informed consent. They were monitored for ADRs till end of treatment and analyzed for characteristics of the ADRs: Causality, severity, and preventability.
Results: Out of 80 patients (mean age of 49.27±16.22 years) enrolled, 51 (63.75%) developed 84 ADRs. Most common ADRs included increased aspartate transaminases, (20.23%), increased bilirubin (19.04%), increased alanine transaminases (13.09%), increased creatinine (11.90%), and increased blood urea (9.52%). Causality assessment using WHO-UMC scale showed, 85.71% possible, 13.09% probable, and 1% certain causal association of the ADRs with remdesivir. A total 75% ADRs were mild in severity and 45% patients recovered from the event at the end of treatment.
Conclusion: Hepatic and Renal dysfunctions are observed with remdesivir in COVID-19 patients. Intensive monitoring of ADRs with newer drugs with EUA such as remdesivir is warranted to ensure safer use in patients.
Downloads
References
Hamzah FB, Lau C, Nazri H, Ligot DV, Lee G, Tan CL, Shaib MK, Zaidon UH, Abdullah AB, Chung MH. CoronaTracker: worldwide COVID-19 outbreak data analysis and prediction. Bull World Health Organ. 2020 Mar 19;1(32).
Wang Y, Zhang D, Du G, Du R, Zhao J, Jin Y, Fu S, Gao L, Cheng Z, Lu Q, Hu Y. Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial. The Lancet. 2020 May 16;395(10236):1569-78.
Pimentel J, Laurie C, Cockcroft A, Andersson N. Clinical studies assessing the efficacy, effectiveness and safety of remdesivir in management of COVID‐19: A scoping review. British journal of clinical pharmacology. 2021 Jul;87(7):2663-84.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/214787Orig1s000lbl.pdf
Spinner CD, Gottlieb RL, Criner GJ, López JR, Cattelan AM, Viladomiu AS, Ogbuagu O, Malhotra P, Mullane KM, Castagna A, Chai LY. Effect of remdesivir vs standard care on clinical status at 11 days in patients with moderate COVID-19: a randomized clinical trial. Jama. 2020 Sep 15;324(11):1048-57.
Naranjo CA, Busto U, Sellars EM, et al. Method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981;30: 239-45.
Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm. 1992;49:2229-32.
Schumock GT, Thornton JP, Focusing on the preventability of adverse drug reactions. Hosp Pharm. 1992; 27: 538.
Zekarias A, Watson S, Vidlin SH, Grundmark B. Sex differences in reported adverse drug reactions to COVID-19 drugs in a global database of individual case safety reports. Drug safety. 2020 Dec;43(12):1309-14.
Grein J, Ohmagari N, Shin D, Diaz G, Asperges E, Castagna A, Feldt T, Green G, Green ML, Lescure FX, Nicastri E. Compassionate use of remdesivir for patients with severe Covid-19. New England Journal of Medicine. 2020 Jun 11;382(24):2327-36.
Charan J, Kaur RJ, Bhardwaj P, Haque M, Sharma P, Misra S, Godman B. Rapid review of suspected adverse drug events due to remdesivir in the WHO database; findings and implications. Expert review of clinical pharmacology. 2021 Jan 2;14(1):95-103.
http://www.ipc.gov.in/images/Drug_Safety_Alert_December_2021.pdf
Published
How to Cite
Issue
Section
Copyright (c) 2022 Miruthu Bashini, Suchi Shah, Chetna Desai
This work is licensed under a Creative Commons Attribution 4.0 International License.
The publication is licensed under CC By and is open access. Copyright is with author and allowed to retain publishing rights without restrictions.