Reações adversas a medicamentos no sistema de farmacovigilância do Brasil, 2008 a 2013: estudo descritivo
The study aimed to analyze suspected adverse drug reactions reported to Brazil’s pharmacovigilance system (Notivisa-medicamento) from 2008 to 2013. This was a descriptive study whose analytical units in the database were reports and drug-adverse reactions pairs. A total of 26,554 reports were identi...
| Autores: | , , |
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| Tipo de recurso: | artículo |
| Estado: | Versión publicada |
| Fecha de publicación: | 2019 |
| País: | Brasil |
| Institución: | Fundação Oswaldo Cruz (FIOCRUZ) |
| Repositorio: | Cadernos de Saúde Pública |
| Idioma: | portugués |
| OAI Identifier: | oai:ojs.teste-cadernos.ensp.fiocruz.br:article/6992 |
| Acceso en línea: | https://cadernos.ensp.fiocruz.br/ojs/index.php/csp/article/view/6992 |
| Access Level: | acceso abierto |
| Palabra clave: | Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos Farmacoepidemiologia Farmacovigilância Sistemas de Notificação de Reações Adversas a Medicamentos |
| Sumario: | The study aimed to analyze suspected adverse drug reactions reported to Brazil’s pharmacovigilance system (Notivisa-medicamento) from 2008 to 2013. This was a descriptive study whose analytical units in the database were reports and drug-adverse reactions pairs. A total of 26,554 reports were identified, for a reporting rate of 22.8/million inhabitants/year. Reports in female patients prevailed (60.5%), as did white color/race (58.1%). Age ranged from 0 to 112 years (median = 46 years). Nearly one-third (32.5%) of suspected adverse drug reactions occurred in vulnerable populations (elderly and children). A total of 54,288 drug- adverse reactions pairs were analyzed, with a prevalence of severe adverse drug reactions (59.2%), featuring those that resulted in clinically important effects (83.1%). The most frequent drugs in severe adverse drug reactions belonged to groups L, antineoplastic and immunomodulating agents (32.1%), and J, general anti-infectious agents for systemic use (27%), while the most affected system-organ-class was conditions of the skin and related disorders (23.7%). Notivisa-medicamento is an important resource for producing warning signs and hypotheses on the safety of drugs marketed in Brazil. However, the reporting rate per million inhabitants/year was far lower than that described in middle and high-income countries. |
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