Adverse Drug Reactions of Potential Antiviral Drugs under Evaluation for the Treatment of COVID-19: Analysis of WHO Global Pharmacovigilance Database

Main Article Content

Sangam Subedi
Nim Bahadur Dangi
Aashish Bhattarai

Abstract

Background: VigiBase database is a world health organization global pharmacovigiliance database of spontaneous reported adverse drug reaction (ADR).There is no standard treatment so far, against Coronavirus disease 2019 ( COVID-19). Azithromycin, chloroquine, hydroxychloroquine, lopinavir, ritonavir, and remdesivir are the potential antiviral drugs under evaluation for the treatment of COVID-19. So, this study aimed to assess spontaneously reported ADRs to these drugs being evaluated for treatment of COVID-19.


Methods:This was a retrospective observational study. ADRs reported till 19th August 2020 retrieved from VigiBase Safety Reports .Comparative analysis was done for the ADRs reported for those drugs.


Results: Gastrointestinal disorders, Injury, poisoning and procedural complication, Investigations, and Skin and subcutaneous tissue disorders were mostly reported for azithromycin (20415), lopinavir(237), remdesivir(1058) and chloroquine (1923) respectively . General disorders and administrative site conditions were mostly reported for hydroxychloroquine (10640) and ritonavir (3348). ADRs reported vary with sex, age group and geographical loactionamong those drugs. Reporting rates were found to decline from 2016 to 2018 in case of Azithromycin and chloroquine whereas reporting rates was found to increase in case of hydroxychloroqine.


Conclusion: Health professionals shall report ADRs observed in the clinical practice and be informed about the reported ADRs through the WHO Global Database.

Downloads

Download data is not yet available.

Article Details

How to Cite
Subedi, S. ., Bahadur Dangi, N. ., & Bhattarai, A. . (2021). Adverse Drug Reactions of Potential Antiviral Drugs under Evaluation for the Treatment of COVID-19: Analysis of WHO Global Pharmacovigilance Database. Nigerian Journal of Pharmaceutical and Applied Science Research, 10(3), 17–22. Retrieved from https://nijophasr.net/index.php/nijophasr/article/view/445
Section
Articles

References

World Health Organization. International drug monitoring: the role of national centers. Geneva: World Health Organization; 1972. 48p. Report No.:498.

World Health Organization. Vigiaccess [Internet]. Uppsala, Sweden: Uppsala Monitoring Centre; 2015 [cited 2020 Aug 19]. Available from: http://www.vigiaccess.org/.

Lindquist M. VigiBase, the WHO global ICSR database system: basic facts. Drug Information Journal. 2008 Sep;42(5):409-19.

World Health Organization [Internet]. Geneva, World Health Organization; 2020. Naming the coronavirus disease (COVID-19) and the virus that causes it; 2020 [cited 2020 Aug 15]. Available from: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance/naming- the-coronavirus-disease-(covid-2019)-and-the-virus-that-causes-it.

World Health Organization. Coronavirus disease 2019 (COVID-19): situation report. Geneva: World Health organization, 2020. 9p. Report No.: 51.

World Health Organization. Coronavirus disease 2019 (COVID-19): situation report. Geneva: World Health Organization, 2020. 16p. Report No.: 209.

Aljofan M, Gaipov A. COVID-19 Treatment: The Race Against Time. Electron J Gen Med. 2020;17(6):em227.

Mucke HAM. COVID-19 and the Drug Repurposing Tsunami. Assay Drug Dev Technol. 2020;18(5):211-214.

COVID-19 Treatment Guidelines Panel. Coronavirus Disease 2019 (COVID-19) Treatment Guidelines. National Institutes of Health; 2020 [cited 2020 Aug 23].Available from: https://www.covid19treatmentguidelines.nih.gov/whats-new/.

US National Library of Medicine [Internet]. Bethesda, MD; 2020. ClinicalTrials.gov; 2020[cited 2020 Aug 24].Available from: www.clinicaltrials.gov.

Aschenbrenner DS. Remdesivir Receives Emergency Use Authorization for Severely Ill Patients with COVID-19. AJN The American Journal of Nursing. 2020 Jul 1;120(7):26.

Bleyzac N, Goutelle S, Bourguignon L, Tod M. Azithromycin for COVID-19: More Than Just an Antimicrobial?.Clin Drug Investig. 2020;40(8):683–6.

Chorin E, Dai M, Shulman E, Wadhwani L, Bar-Cohen R, Barbhaiya C, Aizer A, Holmes D, Bernstein S, Spinelli M, Park DS. The QT interval in patients with COVID-19 treated with hydroxychloroquine and azithromycin. Nature Medicine. 2020 Apr 24:1-2.

Food and Drug Administration [Internet]. United States: United States Government; 2020. FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems; 2020 Jan 07 [cited 2020 Aug 24]. Available from: https://www.fda.gov/drugs/drug-safety-and-availability/fda-cautions-against-use- hydroxychloroquine-or-chloroquine-covid-19-outside-hospital-setting-or

Wang Y, Zhang D, Du G, Du R, Zhao J, Jin Y, et al. Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial. The Lancet. 2020 May;395(10236):1569-78.

Watson S, Caster O, Rochon PA, den Ruijter H. Reported adverse drug reactions in women and men: aggregated evidence from globally collected individual case reports during half a century. EClinicalMedicine. 2019 Dec 1; 17:100188.

Sikdar KC, Alaghehbandan R, MacDonald D, Barrett B, Collins KD, Donnan J, Gadag V. Adverse drug events in adult patients leading to emergency department visits. Annals of Pharmacotherapy. 2010 Apr;44(4):641-9.

Wei RL, Xie YM, Zhang WL. Analysis on 1500 adverse reactions of GuizhiFuling Capsules based on spontaneous response system. ZhongguoZhongyaozazhi= Zhongguozhongyaozazhi= China journal of Chinese material medica. 2019 Apr 1;44(7):1497-502.

Chhabra P, Chen X, Weiss SR. Adverse event reporting patterns of newly approved drugs in the USA in 2006: an analysis of FDA Adverse Event Reporting System data. Drug safety. 2013 Nov 1;36(11):1117-23.

Weber JCP. Epidemiology of adverse reactions to nonsteroidal antiinflammatory drugs. In: Rainaford KD, Velo GP, editors. Side-effects of anti-inflammatory drugs, advances in inflammation research. New York: Raven Press; 1984. P. 1-7