reações adversas causadas por fármacos que atuam no sistema nervoso: análise de registros de um centro de farmacovigilância do brasil adverse reaction caused by drugs acting in nervous system: records analysis of a farmacovigilance center in brazil
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ID: 183692
2009
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Abstract
CONTEXTO: A morbimortalidade por uso de medicamentos é um grande problema de saúde. As reações adversas a medicamentos podem resultar em óbito, aumento de internações hospitalares e dos custos com a saúde. OBJETIVOS: Descrever e analisar as notificações de suspeitas de reações adversas causadas por medicamentos que atuam no sistema nervoso (RAM-SN), registradas no Centro de Farmacovigilância do Ceará, de janeiro de 1997 a março de 2008. MÉTODOS: As RAM-SN foram classificadas segundo os critérios da Organização Mundial da Saúde. Uma relação de causalidade entre o fármaco administrado e a reação adversa identificada foi realizada, bem como a análise da reação quanto à gravidade. RESULTADOS: Foram registradas 176 notificações de RAM-SN. A maioria (n = 145; 82,4%) ocorreu no ambiente hospitalar. O principal notificador foi o farmacêutico. As RAM-SN foram classificadas como: possíveis (n = 110), prováveis (n = 37) e definidas (n = 17). Quanto à gravidade, foram consideradas: leves (n = 21), moderadas (n = 127), graves (n = 15) e fatais (n = 1). O caso fatal foi notificado por médico e envolveu medicamentos anestésicos. Geralmente, as reações adversas observadas foram causadas predominantemente por analgésicos, anestésicos e antiepilépticos. DISCUSSÃO: Os dados demonstram o valor potencial de se ter acesso a sistemas de farmacovigilância local para registrar possíveis riscos com o uso de fármacos.
BACKGROUND: The morbi-mortality by the use of medicines is a major health problem. The drug adverse reactions may result in death, increased hospitalizations and healthcare costs. OBJECTIVES: Describe and analyze reports of suspected adverse reactions caused by drugs that act on the nervous system (SN-ADR), registered in the database of the Pharmacovigilance Centre of Ceará, from January 1997 to March 2008. METHODS: All the NS-ADRs were classified according to criteria of the World Health Organization. The causality between the drug administered and the adverse reaction was established, as well as the analysis regarding to the severity of the reaction. RESULTS: The Centre recorded 176 notifications of RAM-SN. The most of the reactions occurred in the hospital. The main reporter was the pharmacist. All the RAM-SN were classified as possible (n = 110), probable (n = 37) and definite (n = 17). With regard to severity, the NS-ADRs were considered: light (n = 21), moderate (n = 127), serious (n = 15) and fatal (n = 1). The fatal case was reported by physician, and involved anesthetic drugs. In general the adverse reactions observed were caused predominantly by analgesics, anesthetics and antiepileptics. DISCUSSION: The data demonstrate the potential values of accessing to a local system of pharmacovigilance to report possible risks with the use of nervous system drugs.
BACKGROUND: The morbi-mortality by the use of medicines is a major health problem. The drug adverse reactions may result in death, increased hospitalizations and healthcare costs. OBJECTIVES: Describe and analyze reports of suspected adverse reactions caused by drugs that act on the nervous system (SN-ADR), registered in the database of the Pharmacovigilance Centre of Ceará, from January 1997 to March 2008. METHODS: All the NS-ADRs were classified according to criteria of the World Health Organization. The causality between the drug administered and the adverse reaction was established, as well as the analysis regarding to the severity of the reaction. RESULTS: The Centre recorded 176 notifications of RAM-SN. The most of the reactions occurred in the hospital. The main reporter was the pharmacist. All the RAM-SN were classified as possible (n = 110), probable (n = 37) and definite (n = 17). With regard to severity, the NS-ADRs were considered: light (n = 21), moderate (n = 127), serious (n = 15) and fatal (n = 1). The fatal case was reported by physician, and involved anesthetic drugs. In general the adverse reactions observed were caused predominantly by analgesics, anesthetics and antiepileptics. DISCUSSION: The data demonstrate the potential values of accessing to a local system of pharmacovigilance to report possible risks with the use of nervous system drugs.
| Reference Key |
fonteles2009archivesreaes
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| Authors | ;Marta Maria de França Fonteles;Eudiana Vale Francelino;Luciana Kelly Ximenes dos Santos;Karla Marques Silva;Rodrigo Siqueira;Glauce Socorro de Barros Viana;Silvânia Maria Mendes de Vasconcelos;Francisca Cléa Florenço de Sousa;Mirian Parente Monteiro |
| Journal | arthritis research & therapy |
| Year | 2009 |
| DOI |
10.1590/S0101-60832009000400003
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| URL | |
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