Adverse drug reactions in patients with COVID-19 in Brazil: analysis of spontaneous notifications of the Brazilian pharmacovigilance system
Autor(a) principal: | |
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Data de Publicação: | 2021 |
Outros Autores: | , , , , |
Tipo de documento: | Artigo |
Idioma: | eng por |
Título da fonte: | Cadernos de Saúde Pública |
Texto Completo: | https://cadernos.ensp.fiocruz.br/ojs/index.php/csp/article/view/7580 |
Resumo: | In March 2020, the World Health Organization announced the new COVID-19 pandemic, which represented a challenge for health services and professionals. An effective treatment against this disease has not yet been developed; as such, several drugs are used without evidence of efficacy, which in some cases may lead to unwanted events. This is a cross-sectional study with the objective of evaluating adverse drug reactions (ADRs) in patients with COVID-19, identified between March 1 and August 15, 2020, in Brazil, as well as assessing the factors associated with the emergence of severe reactions. To compare the proportions of samples related to the notifier, patient, drugs and adverse events, we used Fisher’s chi-square and exact nonparametric tests; and to compare the means of the data with normal distribution, we used the Student’s t-test and Mann-Whitney’s test. A multivariate logistic regression analysis was also performed, estimating the crude and adjusted odds ratio (OR) by the Stata software, version 10.0. A total of 631 ADRs were identified in 402 patients. The main drugs were hydroxychloroquine (59.5%), azithromycin (9.8%) and chloroquine (5.2%). The reactions manifested primarily in the cardiac system (38.8%), gastrointestinal system (14.4%), skin tissue (12.2%) and hepatic system (8.9%). Chloroquine (OR = 5.4; 95%CI: 1.9-15.6) and hydroxychloroquine (OR = 2.1; 95CI%: 1.2-3.6) were the only drugs associated with severe ADR. Our findings provide support for better practices in pharmacovigilance, contributing to effective and secure regulatory decision-making by the Brazilian Health Regulatory Agency, patients and society as a whole. |
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Adverse drug reactions in patients with COVID-19 in Brazil: analysis of spontaneous notifications of the Brazilian pharmacovigilance systemReações adversas a medicamentos em pacientes com COVID-19 no Brasil: análise das notificações espontâneas do sistema de farmacovigilância brasileiroCoronavirus InfectionsChloroquineHydroxychloroquinePharmacoepidemiologyPatient SafetyInfecções por CoronavírusCloroquinaHidroxicloroquinaFarmacoepidemiologiaSegurança do PacienteIn March 2020, the World Health Organization announced the new COVID-19 pandemic, which represented a challenge for health services and professionals. An effective treatment against this disease has not yet been developed; as such, several drugs are used without evidence of efficacy, which in some cases may lead to unwanted events. This is a cross-sectional study with the objective of evaluating adverse drug reactions (ADRs) in patients with COVID-19, identified between March 1 and August 15, 2020, in Brazil, as well as assessing the factors associated with the emergence of severe reactions. To compare the proportions of samples related to the notifier, patient, drugs and adverse events, we used Fisher’s chi-square and exact nonparametric tests; and to compare the means of the data with normal distribution, we used the Student’s t-test and Mann-Whitney’s test. A multivariate logistic regression analysis was also performed, estimating the crude and adjusted odds ratio (OR) by the Stata software, version 10.0. A total of 631 ADRs were identified in 402 patients. The main drugs were hydroxychloroquine (59.5%), azithromycin (9.8%) and chloroquine (5.2%). The reactions manifested primarily in the cardiac system (38.8%), gastrointestinal system (14.4%), skin tissue (12.2%) and hepatic system (8.9%). Chloroquine (OR = 5.4; 95%CI: 1.9-15.6) and hydroxychloroquine (OR = 2.1; 95CI%: 1.2-3.6) were the only drugs associated with severe ADR. Our findings provide support for better practices in pharmacovigilance, contributing to effective and secure regulatory decision-making by the Brazilian Health Regulatory Agency, patients and society as a whole.En marzo de 2020 la Organización Mundial de la Salud anunció la nueva pandemia denominada COVID-19, representando un desafío para los profesionales y servicios de salud. Todavía no se identificó un tratamiento eficaz contra esta enfermedad y varios fármacos se utilizan sin evidencias de su eficacia, que, en algunos casos, pueden causar eventos indeseados. Este es un estudio transversal, con el objetivo de evaluar las reacciones adversas a medicamentos (RAMs) en pacientes con COVID-19, identificadas desde el 1º de marzo al 15 agosto de 2020 en Brasil, y los factores asociados al surgimiento de reacciones graves. Para comparar las proporciones de las muestras relacionadas con el notificador, paciente, fármacos y eventos adversos, utilizamos los tests no paramétricos chi-cuadrado y exacto de Fisher, y para comparar las medias de los datos con la distribución normal, se utilizó el test t y de Mann-Whitney. También se realizó un análisis de regresión logística multivariable, estimando las odds ratio (OR) brutas y ajustadas, mediante el software Stata, versión 10.0. Se identificaron 631 RAMs en 402 pacientes. Los medicamentos más implicados fueron: hidroxicloroquina (59,5%), azitromicina (9,8%) y la cloroquina (5,2%). Las reacciones se manifestaron prioritariamente en el sistema cardíaco (38,8%), gastrointestinal (14,4%), tejido cutáneo (12,2%) y hepático (8,9%). La cloroquina (OR = 5,4; IC95%: 1,9-15,6) e hidroxicloroquina (OR = 2,1; IC95%: 1,2-3,6) fueron los únicos medicamentos asociados a RAM grave. Nuestros resultados proporcionan apoyo para mejores prácticas en farmacovigilancia, contribuyendo a las tomas de decisiones regulatorias efectivas y seguras, por parte de la Agencia Nacional de Vigilancia Sanitaria, para los pacientes y toda la sociedad.Em março de 2020, a Organização Mundial da Saúde anunciou a nova pandemia denominada de COVID-19, representando um desafio para os profissionais e serviços de saúde. Ainda não foi identificado um tratamento eficaz contra essa doença e vários fármacos são utilizados sem evidências de sua eficácia, que em alguns casos pode causar eventos indesejados. Esse é um estudo transversal com o objetivo de avaliar as reações adversas a medicamentos (RAMs) nos pacientes com COVID-19, identificadas entre 1º de março e 15 agosto de 2020 no Brasil, e os fatores associados ao surgimento de reações graves. Para comparar as proporções das amostras relacionadas ao notificador, paciente, fármacos e eventos adversos utilizamos os testes não paramétricos qui-quadrado e exato de Fisher, e para comparar as médias dos dados com a distribuição normal foi usado o teste t e de Mann-Whitney. Também foi realizada a análise de regressão logística multivariável, estimando as odds ratio (OR) brutas e ajustadas pelo software Stata, versão 10.0. Foram identificadas 631 RAMs em 402 pacientes. Os medicamentos mais envolvidos foram hidroxicloroquina (59,5%), azitromicina (9,8%) e a cloroquina (5,2%). As reações se manifestaram prioritariamente no sistema cardíaco (38,8%), gastrointestinal (14,4%), tecido cutâneo (12,2%) e hepático (8,9%). A cloroquina (OR = 5,4; IC95%: 1,9-15,6) e a hidroxicloroquina (OR = 2,1; IC95%: 1,2-3,6) foram os únicos medicamentos associados a RAM grave. Nossos achados fornecem subsídios para melhores práticas em farmacovigilância, contribuindo para tomadas de decisões regulatórias efetivas e seguras pela Agência Nacional de Vigilância Sanitária, para os pacientes e toda a sociedade.Reports in Public HealthCadernos de Saúde Pública2021-01-22info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersiontext/htmltext/htmlapplication/pdfapplication/pdfhttps://cadernos.ensp.fiocruz.br/ojs/index.php/csp/article/view/7580Reports in Public Health; Vol. 37 No. 1 (2021): JanuaryCadernos de Saúde Pública; v. 37 n. 1 (2021): Janeiro1678-44640102-311Xreponame:Cadernos de Saúde Públicainstname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZengporhttps://cadernos.ensp.fiocruz.br/ojs/index.php/csp/article/view/7580/16866https://cadernos.ensp.fiocruz.br/ojs/index.php/csp/article/view/7580/16867https://cadernos.ensp.fiocruz.br/ojs/index.php/csp/article/view/7580/16868https://cadernos.ensp.fiocruz.br/ojs/index.php/csp/article/view/7580/16869José Romério Rabelo MeloElisabeth Carmen DuarteMarcelo Vogler de MoraesKaren FleckAmanda Soares do Nascimento e SilvaPaulo Sérgio Dourado Arraisinfo:eu-repo/semantics/openAccess2024-03-06T15:30:02Zoai:ojs.teste-cadernos.ensp.fiocruz.br:article/7580Revistahttps://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:2024-03-06T13:08:43.512525Cadernos de Saúde Pública - Fundação Oswaldo Cruz (FIOCRUZ)true |
dc.title.none.fl_str_mv |
Adverse drug reactions in patients with COVID-19 in Brazil: analysis of spontaneous notifications of the Brazilian pharmacovigilance system Reações adversas a medicamentos em pacientes com COVID-19 no Brasil: análise das notificações espontâneas do sistema de farmacovigilância brasileiro |
title |
Adverse drug reactions in patients with COVID-19 in Brazil: analysis of spontaneous notifications of the Brazilian pharmacovigilance system |
spellingShingle |
Adverse drug reactions in patients with COVID-19 in Brazil: analysis of spontaneous notifications of the Brazilian pharmacovigilance system José Romério Rabelo Melo Coronavirus Infections Chloroquine Hydroxychloroquine Pharmacoepidemiology Patient Safety Infecções por Coronavírus Cloroquina Hidroxicloroquina Farmacoepidemiologia Segurança do Paciente |
title_short |
Adverse drug reactions in patients with COVID-19 in Brazil: analysis of spontaneous notifications of the Brazilian pharmacovigilance system |
title_full |
Adverse drug reactions in patients with COVID-19 in Brazil: analysis of spontaneous notifications of the Brazilian pharmacovigilance system |
title_fullStr |
Adverse drug reactions in patients with COVID-19 in Brazil: analysis of spontaneous notifications of the Brazilian pharmacovigilance system |
title_full_unstemmed |
Adverse drug reactions in patients with COVID-19 in Brazil: analysis of spontaneous notifications of the Brazilian pharmacovigilance system |
title_sort |
Adverse drug reactions in patients with COVID-19 in Brazil: analysis of spontaneous notifications of the Brazilian pharmacovigilance system |
author |
José Romério Rabelo Melo |
author_facet |
José Romério Rabelo Melo Elisabeth Carmen Duarte Marcelo Vogler de Moraes Karen Fleck Amanda Soares do Nascimento e Silva Paulo Sérgio Dourado Arrais |
author_role |
author |
author2 |
Elisabeth Carmen Duarte Marcelo Vogler de Moraes Karen Fleck Amanda Soares do Nascimento e Silva Paulo Sérgio Dourado Arrais |
author2_role |
author author author author author |
dc.contributor.author.fl_str_mv |
José Romério Rabelo Melo Elisabeth Carmen Duarte Marcelo Vogler de Moraes Karen Fleck Amanda Soares do Nascimento e Silva Paulo Sérgio Dourado Arrais |
dc.subject.por.fl_str_mv |
Coronavirus Infections Chloroquine Hydroxychloroquine Pharmacoepidemiology Patient Safety Infecções por Coronavírus Cloroquina Hidroxicloroquina Farmacoepidemiologia Segurança do Paciente |
topic |
Coronavirus Infections Chloroquine Hydroxychloroquine Pharmacoepidemiology Patient Safety Infecções por Coronavírus Cloroquina Hidroxicloroquina Farmacoepidemiologia Segurança do Paciente |
description |
In March 2020, the World Health Organization announced the new COVID-19 pandemic, which represented a challenge for health services and professionals. An effective treatment against this disease has not yet been developed; as such, several drugs are used without evidence of efficacy, which in some cases may lead to unwanted events. This is a cross-sectional study with the objective of evaluating adverse drug reactions (ADRs) in patients with COVID-19, identified between March 1 and August 15, 2020, in Brazil, as well as assessing the factors associated with the emergence of severe reactions. To compare the proportions of samples related to the notifier, patient, drugs and adverse events, we used Fisher’s chi-square and exact nonparametric tests; and to compare the means of the data with normal distribution, we used the Student’s t-test and Mann-Whitney’s test. A multivariate logistic regression analysis was also performed, estimating the crude and adjusted odds ratio (OR) by the Stata software, version 10.0. A total of 631 ADRs were identified in 402 patients. The main drugs were hydroxychloroquine (59.5%), azithromycin (9.8%) and chloroquine (5.2%). The reactions manifested primarily in the cardiac system (38.8%), gastrointestinal system (14.4%), skin tissue (12.2%) and hepatic system (8.9%). Chloroquine (OR = 5.4; 95%CI: 1.9-15.6) and hydroxychloroquine (OR = 2.1; 95CI%: 1.2-3.6) were the only drugs associated with severe ADR. Our findings provide support for better practices in pharmacovigilance, contributing to effective and secure regulatory decision-making by the Brazilian Health Regulatory Agency, patients and society as a whole. |
publishDate |
2021 |
dc.date.none.fl_str_mv |
2021-01-22 |
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/7580 |
url |
https://cadernos.ensp.fiocruz.br/ojs/index.php/csp/article/view/7580 |
dc.language.iso.fl_str_mv |
eng por |
language |
eng por |
dc.relation.none.fl_str_mv |
https://cadernos.ensp.fiocruz.br/ojs/index.php/csp/article/view/7580/16866 https://cadernos.ensp.fiocruz.br/ojs/index.php/csp/article/view/7580/16867 https://cadernos.ensp.fiocruz.br/ojs/index.php/csp/article/view/7580/16868 https://cadernos.ensp.fiocruz.br/ojs/index.php/csp/article/view/7580/16869 |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
text/html text/html application/pdf 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. 1 (2021): January Cadernos de Saúde Pública; v. 37 n. 1 (2021): Janeiro 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 |
institution |
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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