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