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Favipiravir Use in COVID-19: Analysis of Suspected Adverse Drug Events Reported in the WHO Database

BACKGROUND: COVID-19 caused by SARS-CoV-2 virus emerged as an unprecedented challenge to discover effective drugs for its prevention and cure. Hyperinflammation-induced lung damage is one of the poor prognostic indicators causing a higher rate of morbidity and mortality of COVID-19 patients. Favipir...

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Autores principales: Kaur, Rimple Jeet, Charan, Jaykaran, Dutta, Siddhartha, Sharma, Paras, Bhardwaj, Pankaj, Sharma, Praveen, Lugova, Halyna, Krishnapillai, Ambigga, Islam, Salequl, Haque, Mainul, Misra, Sanjeev
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dove 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7751706/
https://www.ncbi.nlm.nih.gov/pubmed/33364790
http://dx.doi.org/10.2147/IDR.S287934
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author Kaur, Rimple Jeet
Charan, Jaykaran
Dutta, Siddhartha
Sharma, Paras
Bhardwaj, Pankaj
Sharma, Praveen
Lugova, Halyna
Krishnapillai, Ambigga
Islam, Salequl
Haque, Mainul
Misra, Sanjeev
author_facet Kaur, Rimple Jeet
Charan, Jaykaran
Dutta, Siddhartha
Sharma, Paras
Bhardwaj, Pankaj
Sharma, Praveen
Lugova, Halyna
Krishnapillai, Ambigga
Islam, Salequl
Haque, Mainul
Misra, Sanjeev
author_sort Kaur, Rimple Jeet
collection PubMed
description BACKGROUND: COVID-19 caused by SARS-CoV-2 virus emerged as an unprecedented challenge to discover effective drugs for its prevention and cure. Hyperinflammation-induced lung damage is one of the poor prognostic indicators causing a higher rate of morbidity and mortality of COVID-19 patients. Favipiravir, an antiviral drug, is being used for COVID-19 treatment, and we currently have limited information regarding its efficacy and safety. Thus, the present study was undertaken to evaluate the adverse drug events (ADEs) reported in the WHO pharmacovigilance database. METHODS: This study analyzed all suspected ADEs related to favipiravir reported from 2015. The reports were analyzed based on age, gender, and seriousness of ADEs at the System Organ Classification (SOC) level and the individual Preferred Term (PT) level. RESULTS: This study is based on 194 ADEs reported from 93 patients. Most frequent ADEs suspected to be caused by the favipiravir included increased hepatic enzymes, nausea and vomiting, tachycardia, and diarrhea. Severe and fatal ADEs occurred more frequently in men and those over the age of 64 years. Blood and lymphatic disorders, cardiac disorders, hepatobiliary disorders, injury poisoning, and procedural complications were more common manifestations of severe ADEs. CONCLUSION: This study revealed that favipiravir appears to be a relatively safe drug. An undiscovered anti-inflammatory activity of favipiravir may explain the improvement in critically ill patients and reduce inflammatory markers. Currently, the data is based on very few patients. A more detailed assessment of the uncommon ADEs needs to be analyzed when more information will be available.
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spelling pubmed-77517062020-12-22 Favipiravir Use in COVID-19: Analysis of Suspected Adverse Drug Events Reported in the WHO Database Kaur, Rimple Jeet Charan, Jaykaran Dutta, Siddhartha Sharma, Paras Bhardwaj, Pankaj Sharma, Praveen Lugova, Halyna Krishnapillai, Ambigga Islam, Salequl Haque, Mainul Misra, Sanjeev Infect Drug Resist Original Research BACKGROUND: COVID-19 caused by SARS-CoV-2 virus emerged as an unprecedented challenge to discover effective drugs for its prevention and cure. Hyperinflammation-induced lung damage is one of the poor prognostic indicators causing a higher rate of morbidity and mortality of COVID-19 patients. Favipiravir, an antiviral drug, is being used for COVID-19 treatment, and we currently have limited information regarding its efficacy and safety. Thus, the present study was undertaken to evaluate the adverse drug events (ADEs) reported in the WHO pharmacovigilance database. METHODS: This study analyzed all suspected ADEs related to favipiravir reported from 2015. The reports were analyzed based on age, gender, and seriousness of ADEs at the System Organ Classification (SOC) level and the individual Preferred Term (PT) level. RESULTS: This study is based on 194 ADEs reported from 93 patients. Most frequent ADEs suspected to be caused by the favipiravir included increased hepatic enzymes, nausea and vomiting, tachycardia, and diarrhea. Severe and fatal ADEs occurred more frequently in men and those over the age of 64 years. Blood and lymphatic disorders, cardiac disorders, hepatobiliary disorders, injury poisoning, and procedural complications were more common manifestations of severe ADEs. CONCLUSION: This study revealed that favipiravir appears to be a relatively safe drug. An undiscovered anti-inflammatory activity of favipiravir may explain the improvement in critically ill patients and reduce inflammatory markers. Currently, the data is based on very few patients. A more detailed assessment of the uncommon ADEs needs to be analyzed when more information will be available. Dove 2020-12-14 /pmc/articles/PMC7751706/ /pubmed/33364790 http://dx.doi.org/10.2147/IDR.S287934 Text en © 2020 Kaur et al. http://creativecommons.org/licenses/by-nc/3.0/ This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php).
spellingShingle Original Research
Kaur, Rimple Jeet
Charan, Jaykaran
Dutta, Siddhartha
Sharma, Paras
Bhardwaj, Pankaj
Sharma, Praveen
Lugova, Halyna
Krishnapillai, Ambigga
Islam, Salequl
Haque, Mainul
Misra, Sanjeev
Favipiravir Use in COVID-19: Analysis of Suspected Adverse Drug Events Reported in the WHO Database
title Favipiravir Use in COVID-19: Analysis of Suspected Adverse Drug Events Reported in the WHO Database
title_full Favipiravir Use in COVID-19: Analysis of Suspected Adverse Drug Events Reported in the WHO Database
title_fullStr Favipiravir Use in COVID-19: Analysis of Suspected Adverse Drug Events Reported in the WHO Database
title_full_unstemmed Favipiravir Use in COVID-19: Analysis of Suspected Adverse Drug Events Reported in the WHO Database
title_short Favipiravir Use in COVID-19: Analysis of Suspected Adverse Drug Events Reported in the WHO Database
title_sort favipiravir use in covid-19: analysis of suspected adverse drug events reported in the who database
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7751706/
https://www.ncbi.nlm.nih.gov/pubmed/33364790
http://dx.doi.org/10.2147/IDR.S287934
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