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[Safety profile of heterologous serum produced by the Butantan Institute, in São Paulo-SP, Brazil, from 2012 to 2015]. / Perfil de segurança dos soros heterólogos produzidos pelo Instituto Butantan, São Paulo-SP, no período de 2012 a 2015.
Gattás, Vera Lúcia; Braga, Patrícia Emília; Koike, Marcelo Eiji; Lucchesi, Maria Beatriz; Precioso, Alexander Roberto.
Afiliação
  • Gattás VL; Instituto Butantan, Divisão de Ensaios Clínicos e Farmacovigilância, São Paulo-SP, Brasil.
  • Braga PE; Instituto Butantan, Divisão de Ensaios Clínicos e Farmacovigilância, São Paulo-SP, Brasil.
  • Koike ME; Instituto Butantan, Divisão de Ensaios Clínicos e Farmacovigilância, São Paulo-SP, Brasil.
  • Lucchesi MB; Instituto Butantan, Divisão de Ensaios Clínicos e Farmacovigilância, São Paulo-SP, Brasil.
  • Precioso AR; Instituto Butantan, Divisão de Ensaios Clínicos e Farmacovigilância, São Paulo-SP, Brasil.
Epidemiol Serv Saude ; 26(3): 639-647, 2017.
Article em Pt | MEDLINE | ID: mdl-28977188
OBJECTIVE: to describe the safety profile of the heterologous serum produced by the Butantan Institute (BI) of São Paulo-SP, Brazil. METHODS: a descriptive study of adverse events (AEs) post-exposure to serum produced by the BI, encoded in the medical terminology of the Medical Dictionary for Regulatory Activities (MedDRA), and spontaneously reported to BI from 2012 to 2015. RESULTS: 52 individuals reported AEs, mainly related to Bothrops antivenom (n=11), diphtheria antitoxin (n=9) and unspecified snakebite serum (n=9); a mean of 3.2 AEs per individual was observed; among the total of 173 AEs, 63.0% were expected considering that they were described in the package insert; most of them were classified as skin and subcutaneous tissue disorders (30.6%); there were six deaths temporally related to the use of serum, but this association was discarded. CONCLUSION: in the studied period, the serum produced by the BI had no changes in their safety profiles, considering that the AEs were expected, according to the information previously described in the package insert.
Assuntos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Antitoxinas / Soros Imunes Limite: Adolescent / Adult / Child / Child, preschool / Female / Humans / Male / Middle aged País/Região como assunto: America do sul / Brasil Idioma: Pt Revista: Epidemiol Serv Saude Ano de publicação: 2017 Tipo de documento: Article País de afiliação: Brasil País de publicação: Brasil

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Antitoxinas / Soros Imunes Limite: Adolescent / Adult / Child / Child, preschool / Female / Humans / Male / Middle aged País/Região como assunto: America do sul / Brasil Idioma: Pt Revista: Epidemiol Serv Saude Ano de publicação: 2017 Tipo de documento: Article País de afiliação: Brasil País de publicação: Brasil