PMID- 28977188
OWN - NLM
STAT- MEDLINE
DCOM- 20181219
LR  - 20181219
IS  - 2237-9622 (Electronic)
IS  - 1679-4974 (Linking)
VI  - 26
IP  - 3
DP  - 2017 Jul-Sep
TI  - [Safety profile of heterologous serum produced by the Butantan Institute, in Sao 
      Paulo-SP, Brazil, from 2012 to 2015].
PG  - 639-647
LID - S2237-96222017000300639 [pii]
LID - 10.5123/S1679-49742017000300021 [doi]
AB  - OBJECTIVE: to describe the safety profile of the heterologous serum produced by 
      the Butantan Institute (BI) of Sao 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.
FAU - Gattas, Vera Lucia
AU  - Gattas VL
AD  - Instituto Butantan, Divisao de Ensaios Clinicos e Farmacovigilancia, Sao 
      Paulo-SP, Brasil.
FAU - Braga, Patricia Emilia
AU  - Braga PE
AD  - Instituto Butantan, Divisao de Ensaios Clinicos e Farmacovigilancia, Sao 
      Paulo-SP, Brasil.
FAU - Koike, Marcelo Eiji
AU  - Koike ME
AD  - Instituto Butantan, Divisao de Ensaios Clinicos e Farmacovigilancia, Sao 
      Paulo-SP, Brasil.
FAU - Lucchesi, Maria Beatriz
AU  - Lucchesi MB
AD  - Instituto Butantan, Divisao de Ensaios Clinicos e Farmacovigilancia, Sao 
      Paulo-SP, Brasil.
FAU - Precioso, Alexander Roberto
AU  - Precioso AR
AD  - Instituto Butantan, Divisao de Ensaios Clinicos e Farmacovigilancia, Sao 
      Paulo-SP, Brasil.
LA  - por
PT  - Journal Article
TT  - Perfil de seguranca dos soros heterologos produzidos pelo Instituto Butantan, Sao 
      Paulo-SP, no periodo de 2012 a 2015.
PL  - Brazil
TA  - Epidemiol Serv Saude
JT  - Epidemiologia e servicos de saude : revista do Sistema Unico de Saude do Brasil
JID - 101248287
RN  - 0 (Antitoxins)
RN  - 0 (Immune Sera)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Antitoxins/administration & dosage/*adverse effects
MH  - Brazil
MH  - Child
MH  - Child, Preschool
MH  - Female
MH  - Humans
MH  - Immune Sera/administration & dosage/*adverse effects
MH  - Immunization, Passive/adverse effects
MH  - Male
MH  - Middle Aged
MH  - Young Adult
EDAT- 2017/10/05 06:00
MHDA- 2018/12/20 06:00
CRDT- 2017/10/05 06:00
PHST- 2016/10/14 00:00 [received]
PHST- 2017/03/24 00:00 [accepted]
PHST- 2017/10/05 06:00 [entrez]
PHST- 2017/10/05 06:00 [pubmed]
PHST- 2018/12/20 06:00 [medline]
AID - S2237-96222017000300639 [pii]
AID - 10.5123/S1679-49742017000300021 [doi]
PST - ppublish
SO  - Epidemiol Serv Saude. 2017 Jul-Sep;26(3):639-647. doi: 
      10.5123/S1679-49742017000300021.