Analysis of reported adverse liver reactions associated with drugs used to treat patients with coronavirus disease 2019

Detalhes bibliográficos
Autor(a) principal: Nayara Aparecida de Oliveira-Silva
Data de Publicação: 2023
Outros Autores: Albert Figueras, Daniela Oliveira de Melo
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Brazilian Journal of Pharmaceutical Sciences
Texto Completo: https://www.revistas.usp.br/bjps/article/view/214264
Resumo: Hepatic injury has been documented in patients with coronavirus disease 2019 (COVID-19). However, pharmacotherapy can frequently impact liver alterations, given the known hepatotoxic potential of drugs not effective to treat COVID-19. The objective of the present study was to evaluate reports of suspected liver reactions to drugs used for treating COVID-19, compare their use for other indications among patients with COVID-19, and assess possible interactions between them. We obtained reports on drugs used to treat COVID-19 (tocilizumab, remdesivir, hydroxychloroquine, and/or lopinavir/ritonavir), registered on June 30, 2020, from the Food and Drug Administration Adverse Event Reporting System (FAERS) Public Dashboard. We then analyzed the risk of developing liver events with these drugs by calculating the reported odds ratios (ROR). We identified 662, 744, and 1381 reports related to tocilizumab, lopinavir/ ritonavir, and hydroxychloroquine use, respectively. The RORs (95% confidence intervals) were 6.32 (5.28-7.56), 6.12 (5.22-7.17), and 9.07 (8.00-10.29), respectively, demonstrating an increased risk of liver events among patients with COVID-19 when compared with uninfected patients. The elevated risk of reporting adverse liver events in patients with COVID-19 who receive these drugs, alone or in combination, highlights the need for careful drug selection and efforts to reduce drug combinations without notable benefits. Similar to any other condition, the use of drugs without established efficacy should be avoided.
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spelling Analysis of reported adverse liver reactions associated with drugs used to treat patients with coronavirus disease 2019COVID-19HepatotoxicityPharmacovigilanceDrug-drug interactionHepatic injury has been documented in patients with coronavirus disease 2019 (COVID-19). However, pharmacotherapy can frequently impact liver alterations, given the known hepatotoxic potential of drugs not effective to treat COVID-19. The objective of the present study was to evaluate reports of suspected liver reactions to drugs used for treating COVID-19, compare their use for other indications among patients with COVID-19, and assess possible interactions between them. We obtained reports on drugs used to treat COVID-19 (tocilizumab, remdesivir, hydroxychloroquine, and/or lopinavir/ritonavir), registered on June 30, 2020, from the Food and Drug Administration Adverse Event Reporting System (FAERS) Public Dashboard. We then analyzed the risk of developing liver events with these drugs by calculating the reported odds ratios (ROR). We identified 662, 744, and 1381 reports related to tocilizumab, lopinavir/ ritonavir, and hydroxychloroquine use, respectively. The RORs (95% confidence intervals) were 6.32 (5.28-7.56), 6.12 (5.22-7.17), and 9.07 (8.00-10.29), respectively, demonstrating an increased risk of liver events among patients with COVID-19 when compared with uninfected patients. The elevated risk of reporting adverse liver events in patients with COVID-19 who receive these drugs, alone or in combination, highlights the need for careful drug selection and efforts to reduce drug combinations without notable benefits. Similar to any other condition, the use of drugs without established efficacy should be avoided.Universidade de São Paulo. Faculdade de Ciências Farmacêuticas2023-07-12info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://www.revistas.usp.br/bjps/article/view/21426410.1590/s2175-97902023e21471Brazilian Journal of Pharmaceutical Sciences; Vol. 59 (2023)Brazilian Journal of Pharmaceutical Sciences; v. 59 (2023)Brazilian Journal of Pharmaceutical Sciences; Vol. 59 (2023)2175-97901984-8250reponame:Brazilian Journal of Pharmaceutical Sciencesinstname:Universidade de São Paulo (USP)instacron:USPenghttps://www.revistas.usp.br/bjps/article/view/214264/196573Copyright (c) 2023 Brazilian Journal of Pharmaceutical Scienceshttps://creativecommons.org/licenses/by/4.0info:eu-repo/semantics/openAccessNayara Aparecida de Oliveira-SilvaAlbert FiguerasDaniela Oliveira de Melo2023-07-12T19:01:45Zoai:revistas.usp.br:article/214264Revistahttps://www.revistas.usp.br/bjps/indexPUBhttps://old.scielo.br/oai/scielo-oai.phpbjps@usp.br||elizabeth.igne@gmail.com2175-97901984-8250opendoar:2023-07-12T19:01:45Brazilian Journal of Pharmaceutical Sciences - Universidade de São Paulo (USP)false
dc.title.none.fl_str_mv Analysis of reported adverse liver reactions associated with drugs used to treat patients with coronavirus disease 2019
title Analysis of reported adverse liver reactions associated with drugs used to treat patients with coronavirus disease 2019
spellingShingle Analysis of reported adverse liver reactions associated with drugs used to treat patients with coronavirus disease 2019
Nayara Aparecida de Oliveira-Silva
COVID-19
Hepatotoxicity
Pharmacovigilance
Drug-drug interaction
title_short Analysis of reported adverse liver reactions associated with drugs used to treat patients with coronavirus disease 2019
title_full Analysis of reported adverse liver reactions associated with drugs used to treat patients with coronavirus disease 2019
title_fullStr Analysis of reported adverse liver reactions associated with drugs used to treat patients with coronavirus disease 2019
title_full_unstemmed Analysis of reported adverse liver reactions associated with drugs used to treat patients with coronavirus disease 2019
title_sort Analysis of reported adverse liver reactions associated with drugs used to treat patients with coronavirus disease 2019
author Nayara Aparecida de Oliveira-Silva
author_facet Nayara Aparecida de Oliveira-Silva
Albert Figueras
Daniela Oliveira de Melo
author_role author
author2 Albert Figueras
Daniela Oliveira de Melo
author2_role author
author
dc.contributor.author.fl_str_mv Nayara Aparecida de Oliveira-Silva
Albert Figueras
Daniela Oliveira de Melo
dc.subject.por.fl_str_mv COVID-19
Hepatotoxicity
Pharmacovigilance
Drug-drug interaction
topic COVID-19
Hepatotoxicity
Pharmacovigilance
Drug-drug interaction
description Hepatic injury has been documented in patients with coronavirus disease 2019 (COVID-19). However, pharmacotherapy can frequently impact liver alterations, given the known hepatotoxic potential of drugs not effective to treat COVID-19. The objective of the present study was to evaluate reports of suspected liver reactions to drugs used for treating COVID-19, compare their use for other indications among patients with COVID-19, and assess possible interactions between them. We obtained reports on drugs used to treat COVID-19 (tocilizumab, remdesivir, hydroxychloroquine, and/or lopinavir/ritonavir), registered on June 30, 2020, from the Food and Drug Administration Adverse Event Reporting System (FAERS) Public Dashboard. We then analyzed the risk of developing liver events with these drugs by calculating the reported odds ratios (ROR). We identified 662, 744, and 1381 reports related to tocilizumab, lopinavir/ ritonavir, and hydroxychloroquine use, respectively. The RORs (95% confidence intervals) were 6.32 (5.28-7.56), 6.12 (5.22-7.17), and 9.07 (8.00-10.29), respectively, demonstrating an increased risk of liver events among patients with COVID-19 when compared with uninfected patients. The elevated risk of reporting adverse liver events in patients with COVID-19 who receive these drugs, alone or in combination, highlights the need for careful drug selection and efforts to reduce drug combinations without notable benefits. Similar to any other condition, the use of drugs without established efficacy should be avoided.
publishDate 2023
dc.date.none.fl_str_mv 2023-07-12
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv https://www.revistas.usp.br/bjps/article/view/214264
10.1590/s2175-97902023e21471
url https://www.revistas.usp.br/bjps/article/view/214264
identifier_str_mv 10.1590/s2175-97902023e21471
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv https://www.revistas.usp.br/bjps/article/view/214264/196573
dc.rights.driver.fl_str_mv Copyright (c) 2023 Brazilian Journal of Pharmaceutical Sciences
https://creativecommons.org/licenses/by/4.0
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Copyright (c) 2023 Brazilian Journal of Pharmaceutical Sciences
https://creativecommons.org/licenses/by/4.0
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Universidade de São Paulo. Faculdade de Ciências Farmacêuticas
publisher.none.fl_str_mv Universidade de São Paulo. Faculdade de Ciências Farmacêuticas
dc.source.none.fl_str_mv Brazilian Journal of Pharmaceutical Sciences; Vol. 59 (2023)
Brazilian Journal of Pharmaceutical Sciences; v. 59 (2023)
Brazilian Journal of Pharmaceutical Sciences; Vol. 59 (2023)
2175-9790
1984-8250
reponame:Brazilian Journal of Pharmaceutical Sciences
instname:Universidade de São Paulo (USP)
instacron:USP
instname_str Universidade de São Paulo (USP)
instacron_str USP
institution USP
reponame_str Brazilian Journal of Pharmaceutical Sciences
collection Brazilian Journal of Pharmaceutical Sciences
repository.name.fl_str_mv Brazilian Journal of Pharmaceutical Sciences - Universidade de São Paulo (USP)
repository.mail.fl_str_mv bjps@usp.br||elizabeth.igne@gmail.com
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