Potential kidney damage associated with the use of remdesivir for COVID-19: analysis of a pharmacovigilance database
Autor(a) principal: | |
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Data de Publicação: | 2021 |
Outros Autores: | , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Cadernos de Saúde Pública |
Texto Completo: | https://cadernos.ensp.fiocruz.br/ojs/index.php/csp/article/view/7845 |
Resumo: | The U.S. Food and Drug Administration (FDA) has stated that the prescription of remdesivir should be cautious for patients with estimated glomerular filtration rate (eGFR) < 30 and some studies reported risk of adverse renal events. The available information on the renal safety profile for remdesivir is limited, thus we analyzed the renal and urinary adverse reactions attributed to remdesivir reported in a large open pharmacovigilance database. We obtained reports of remdesivir and other drugs used to treat COVID-19 (tocilizumab, hydroxychloroquine, lopinavir/ritonavir) registered by September 30 2020, from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS). We analyzed the reporting odds ratios (RORs) for reports of adverse renal and urinary events for remdesivir and other drugs. We found 2,922 reports with remdesivir registered in FAERS for COVID-19. Among these, 493 renal and urinary adverse effects (16.9%) were reported. The most frequent events were acute kidney injury (338; 11.6%), renal impairment (86; 2.9%), and renal failure (53; 1.8%). Versus hydroxychloroquine, lopinavir/ritonavir, or tocilizumab, the use of remdesivir was associated with an increased chance of reporting renal and urinary disorders regardless of gender and age of patients (2.53; 95%CI: 2.10-3.06). The ROR remained significant when we restricted the analysis to hydroxychloroquine (4.31; 95%CI: 3.25-5.71) or tocilizumab (3.92; 95%CI: 2.51-6.12). Our results reinforce this already reported signal, emphasizing that it could be extremely useful for health professionals who prescribe this new antiviral to treat COVID-19, mainly knowing its low efficacy. |
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Potential kidney damage associated with the use of remdesivir for COVID-19: analysis of a pharmacovigilance databaseCoronavirus InfectionsPharmacovigilanceAdverse Drug Reaction Reporting SystemsDrug-Related Side Effects and Adverse ReactionsThe U.S. Food and Drug Administration (FDA) has stated that the prescription of remdesivir should be cautious for patients with estimated glomerular filtration rate (eGFR) < 30 and some studies reported risk of adverse renal events. The available information on the renal safety profile for remdesivir is limited, thus we analyzed the renal and urinary adverse reactions attributed to remdesivir reported in a large open pharmacovigilance database. We obtained reports of remdesivir and other drugs used to treat COVID-19 (tocilizumab, hydroxychloroquine, lopinavir/ritonavir) registered by September 30 2020, from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS). We analyzed the reporting odds ratios (RORs) for reports of adverse renal and urinary events for remdesivir and other drugs. We found 2,922 reports with remdesivir registered in FAERS for COVID-19. Among these, 493 renal and urinary adverse effects (16.9%) were reported. The most frequent events were acute kidney injury (338; 11.6%), renal impairment (86; 2.9%), and renal failure (53; 1.8%). Versus hydroxychloroquine, lopinavir/ritonavir, or tocilizumab, the use of remdesivir was associated with an increased chance of reporting renal and urinary disorders regardless of gender and age of patients (2.53; 95%CI: 2.10-3.06). The ROR remained significant when we restricted the analysis to hydroxychloroquine (4.31; 95%CI: 3.25-5.71) or tocilizumab (3.92; 95%CI: 2.51-6.12). Our results reinforce this already reported signal, emphasizing that it could be extremely useful for health professionals who prescribe this new antiviral to treat COVID-19, mainly knowing its low efficacy.La Agencia Americana de Control de Alimentos y Medicamentos (FDA) ha destacado que la prescripción de remdesivir debe ser prudente con pacientes con tasa de filtración glomerular estimada (TGFe) < 30; además, algunos estudios informaron del riesgo de reacciones adversas renales. La información disponible sobre el perfil de seguridad renal, en el caso del remdesivir, es limitada. Por ello, analizamos las reacciones adversas renales y urinarias atribuidas al remdesivir e notificadas en una extensa base de datos abierta de farmacovigilancia. Obtuvimos las notificaciones de remdesivir y otros medicamentos usados para tratar la COVID-19 (tocilizumab, hidroxicloroquina, lopinavir/ritonavir) registrados el 30 de septiembre de 2020 por el Sistema de Notificación de Eventos Adversos de la FDA (FAERS). Analizamos las odds ratios informadas (RORs) en el caso de informes de eventos adversos renales y urinarios adversos relacionados con el remdesivir y otros medicamentos. En el FAERS, encontramos 2.922 notificaciones de remdesivir registradas como medicament sospechoso usado en COVID-19. De estos, habían 493 con efectos renales y urinarios adversos (16,9%). Los efectos adversos más frecuentes fueron lesiones renales agudas (338; 11,6%), insuficiencia renal (86; 2,9%), y fallo renal (53; 1,8%). Frente a hidroxicloroquina, lopinavir/ritonavir, o tocilizumab, el uso de remdesivir se asoció con un riesgo mayor de notificar alteraciones renales y urinarios, independientemente del género y edad de los pacientes (2,53; IC95%: 2,10-3,06). La ROR permaneció significativo al restringir el análisis a la hidroxicloroquina (4,31; IC95%: 3,25-5,71) o tocilizumab (3,92; IC95%: 2,51-6,12). Nuestros resultados corroboran datos previos, algo que podría ser extremadamente útil para los profesionales de la salud que decidan usar este nuevo antiviral para tratar la COVID-19, sobre todo conociendo su baja eficacia.De acordo com a Agência de Controle de Alimentos e Medicamentos dos Estados Unidos (FDA), a prescrição do remdesivir deve ser feita com cautela em pacientes com taxa de filtração glomerular estimada (TFGe) < 30, sendo que diversos estudos relatam risco de eventos adversos renais. São limitados os dados disponíveis sobre o perfil de segurança renal do remdesivir. Assim, analisamos as reações adversas renais e urinárias atribuídas ao remdesivir e notificadas em um grande base de dados abertos de farmacovigilância. Obtivemos notificações sobre remdesivir e outros medicamentos usados para tratar a COVID-19 (tocilizumabe, hidroxicloroquina, lopinavir/ritonavir) registradas até 30 de setembro de 2020 do Sistema de Notificação de Eventos Adversos da FDA (FAERS). Analisamos as razões de chances de notificação (RORs) para notificações de eventos adversos renais e urinários referentes ao remdesivir e outros medicamentos. Encontramos 2.922 notificações sobre remdesivir registradas no FAERS para COVID-19. Entre esses casos, foram notificados 493 efeitos adversos renais e urinários (16,9%). Os eventos mais frequentes foram lesão renal aguda (338; 11,6%), comprometimento renal (86; 2,9%) e insuficiência renal (53; 1,8%). Comparado com a hidroxicloroquina, lopinavir/ritonavir ou tocilizumabe, o uso do remdesivir esteve associado com um aumento das chances de notificação de transtornos renais e urinários, independentemente do sexo e idade dos pacientes (2,53; IC95%: 2,10-3,06). A ROR permaneceu significativo quando limitamos a análise à hidroxicloroquina (4,31; IC95%: 3,25-5,71) ou ao tocilizumabe (3,92; IC95%: 2,51-6,12). Nossos resultados corroboram outros estudos e destacam a utilidade para profissionais da saúde que usam esse novo antiviral para tratar a COVID-19, sobretudo em função de sua baixa eficácia.Reports in Public HealthCadernos de Saúde Pública2021-11-12info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersiontext/htmlapplication/pdfhttps://cadernos.ensp.fiocruz.br/ojs/index.php/csp/article/view/7845Reports in Public Health; Vol. 37 No. 10 (2021): OctoberCadernos de Saúde Pública; v. 37 n. 10 (2021): Outubro1678-44640102-311Xreponame:Cadernos de Saúde Públicainstname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZenghttps://cadernos.ensp.fiocruz.br/ojs/index.php/csp/article/view/7845/17552https://cadernos.ensp.fiocruz.br/ojs/index.php/csp/article/view/7845/17553Nayara Aparecida de Oliveira SilvaAna Laura de Sene Amâncio ZaraAlbert FiguerasDaniela Oliveira de Meloinfo:eu-repo/semantics/openAccess2024-03-06T15:30:12Zoai:ojs.teste-cadernos.ensp.fiocruz.br:article/7845Revistahttps://cadernos.ensp.fiocruz.br/ojs/index.php/csphttps://cadernos.ensp.fiocruz.br/ojs/index.php/csp/oaicadernos@ensp.fiocruz.br||cadernos@ensp.fiocruz.br1678-44640102-311Xopendoar:2024-03-06T13:09:00.630135Cadernos de Saúde Pública - Fundação Oswaldo Cruz (FIOCRUZ)true |
dc.title.none.fl_str_mv |
Potential kidney damage associated with the use of remdesivir for COVID-19: analysis of a pharmacovigilance database |
title |
Potential kidney damage associated with the use of remdesivir for COVID-19: analysis of a pharmacovigilance database |
spellingShingle |
Potential kidney damage associated with the use of remdesivir for COVID-19: analysis of a pharmacovigilance database Nayara Aparecida de Oliveira Silva Coronavirus Infections Pharmacovigilance Adverse Drug Reaction Reporting Systems Drug-Related Side Effects and Adverse Reactions |
title_short |
Potential kidney damage associated with the use of remdesivir for COVID-19: analysis of a pharmacovigilance database |
title_full |
Potential kidney damage associated with the use of remdesivir for COVID-19: analysis of a pharmacovigilance database |
title_fullStr |
Potential kidney damage associated with the use of remdesivir for COVID-19: analysis of a pharmacovigilance database |
title_full_unstemmed |
Potential kidney damage associated with the use of remdesivir for COVID-19: analysis of a pharmacovigilance database |
title_sort |
Potential kidney damage associated with the use of remdesivir for COVID-19: analysis of a pharmacovigilance database |
author |
Nayara Aparecida de Oliveira Silva |
author_facet |
Nayara Aparecida de Oliveira Silva Ana Laura de Sene Amâncio Zara Albert Figueras Daniela Oliveira de Melo |
author_role |
author |
author2 |
Ana Laura de Sene Amâncio Zara Albert Figueras Daniela Oliveira de Melo |
author2_role |
author author author |
dc.contributor.author.fl_str_mv |
Nayara Aparecida de Oliveira Silva Ana Laura de Sene Amâncio Zara Albert Figueras Daniela Oliveira de Melo |
dc.subject.por.fl_str_mv |
Coronavirus Infections Pharmacovigilance Adverse Drug Reaction Reporting Systems Drug-Related Side Effects and Adverse Reactions |
topic |
Coronavirus Infections Pharmacovigilance Adverse Drug Reaction Reporting Systems Drug-Related Side Effects and Adverse Reactions |
description |
The U.S. Food and Drug Administration (FDA) has stated that the prescription of remdesivir should be cautious for patients with estimated glomerular filtration rate (eGFR) < 30 and some studies reported risk of adverse renal events. The available information on the renal safety profile for remdesivir is limited, thus we analyzed the renal and urinary adverse reactions attributed to remdesivir reported in a large open pharmacovigilance database. We obtained reports of remdesivir and other drugs used to treat COVID-19 (tocilizumab, hydroxychloroquine, lopinavir/ritonavir) registered by September 30 2020, from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS). We analyzed the reporting odds ratios (RORs) for reports of adverse renal and urinary events for remdesivir and other drugs. We found 2,922 reports with remdesivir registered in FAERS for COVID-19. Among these, 493 renal and urinary adverse effects (16.9%) were reported. The most frequent events were acute kidney injury (338; 11.6%), renal impairment (86; 2.9%), and renal failure (53; 1.8%). Versus hydroxychloroquine, lopinavir/ritonavir, or tocilizumab, the use of remdesivir was associated with an increased chance of reporting renal and urinary disorders regardless of gender and age of patients (2.53; 95%CI: 2.10-3.06). The ROR remained significant when we restricted the analysis to hydroxychloroquine (4.31; 95%CI: 3.25-5.71) or tocilizumab (3.92; 95%CI: 2.51-6.12). Our results reinforce this already reported signal, emphasizing that it could be extremely useful for health professionals who prescribe this new antiviral to treat COVID-19, mainly knowing its low efficacy. |
publishDate |
2021 |
dc.date.none.fl_str_mv |
2021-11-12 |
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://cadernos.ensp.fiocruz.br/ojs/index.php/csp/article/view/7845 |
url |
https://cadernos.ensp.fiocruz.br/ojs/index.php/csp/article/view/7845 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
https://cadernos.ensp.fiocruz.br/ojs/index.php/csp/article/view/7845/17552 https://cadernos.ensp.fiocruz.br/ojs/index.php/csp/article/view/7845/17553 |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
text/html application/pdf |
dc.publisher.none.fl_str_mv |
Reports in Public Health Cadernos de Saúde Pública |
publisher.none.fl_str_mv |
Reports in Public Health Cadernos de Saúde Pública |
dc.source.none.fl_str_mv |
Reports in Public Health; Vol. 37 No. 10 (2021): October Cadernos de Saúde Pública; v. 37 n. 10 (2021): Outubro 1678-4464 0102-311X reponame:Cadernos de Saúde Pública instname:Fundação Oswaldo Cruz (FIOCRUZ) instacron:FIOCRUZ |
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Fundação Oswaldo Cruz (FIOCRUZ) |
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FIOCRUZ |
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FIOCRUZ |
reponame_str |
Cadernos de Saúde Pública |
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Cadernos de Saúde Pública |
repository.name.fl_str_mv |
Cadernos de Saúde Pública - Fundação Oswaldo Cruz (FIOCRUZ) |
repository.mail.fl_str_mv |
cadernos@ensp.fiocruz.br||cadernos@ensp.fiocruz.br |
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