Document Detail

Safety of botulinum toxin type A in children younger than 2 years.
MedLine Citation:
PMID:  19036619     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Botulinum toxin type A (BoNT-A) has been used in many indications and is licensed for the treatment of spasticity in children older than 2 years. However, there are few reports of BoNT-A treatment in patients younger than 2 years of age. AIMS: To review retrospectively the safety data from all infants treated with botulinum toxin type A (BoNT-A) before 2 years of age in a paediatric neurology unit. METHODS: There were 74 infants: 28 received the first dose before 1 year of age, and 46 between the ages of 1 and 2 years. RESULTS: In the first year of life, the most frequent indication was obstetric brachial palsy (OBP) (71.4% of cases) and in the second year, cerebral palsy (CP) (73.9%). Both Botox and Dysport, the two commercially-available BoNT-A products in Spain, were used. The average starting dose by session was 6.55 U/kg body weight Botox in infants in their first year of life, and 8.4 U/kg body weight Botox and 21.1 U/kg body weight Dysport in the second year of life. Only 3.6% of cases treated in the first year and 6.5% of those treated in the second experienced adverse events (AEs), which consisted of mild weakness or tiredness lasting 1-4 days. CONCLUSIONS: BoNT-A has a good safety profile in infants younger than 2 years old. AEs are similar to those found in older children.
Samuel Ignacio Pascual-Pascual; Ignacio Pascual-Castroviejo
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Publication Detail:
Type:  Journal Article     Date:  2008-11-25
Journal Detail:
Title:  European journal of paediatric neurology : EJPN : official journal of the European Paediatric Neurology Society     Volume:  13     ISSN:  1532-2130     ISO Abbreviation:  Eur. J. Paediatr. Neurol.     Publication Date:  2009 Nov 
Date Detail:
Created Date:  2009-11-02     Completed Date:  2010-01-14     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9715169     Medline TA:  Eur J Paediatr Neurol     Country:  England    
Other Details:
Languages:  eng     Pagination:  511-5     Citation Subset:  IM    
Pediatric Neurology Service, University Hospital La Paz, Paseo de la Castellana 261, 28046 Madrid, Spain.
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MeSH Terms
Botulinum Toxin Type A / adverse effects*,  therapeutic use
Cerebral Palsy / drug therapy
Drug Toxicity / chemically induced*
Neuromuscular Agents / adverse effects*,  therapeutic use
Paralysis, Obstetric / drug therapy
Retrospective Studies
Severity of Illness Index
Spasm / drug therapy
Treatment Outcome
Reg. No./Substance:
0/Botulinum Toxin Type A; 0/Neuromuscular Agents

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