PMID- 19036619 OWN - NLM STAT- MEDLINE DCOM- 20100114 LR - 20131121 IS - 1532-2130 (Electronic) IS - 1090-3798 (Linking) VI - 13 IP - 6 DP - 2009 Nov TI - Safety of botulinum toxin type A in children younger than 2 years. PG - 511-5 LID - 10.1016/j.ejpn.2008.10.006 [doi] AB - 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. FAU - Pascual-Pascual, Samuel Ignacio AU - Pascual-Pascual SI AD - Pediatric Neurology Service, University Hospital La Paz, Paseo de la Castellana 261, 28046 Madrid, Spain. ipascualp.hulp@salud.madrid.org FAU - Pascual-Castroviejo, Ignacio AU - Pascual-Castroviejo I LA - eng PT - Journal Article DEP - 20081125 PL - England TA - Eur J Paediatr Neurol JT - European journal of paediatric neurology : EJPN : official journal of the European Paediatric Neurology Society JID - 9715169 RN - 0 (Neuromuscular Agents) RN - EC 3.4.24.69 (Botulinum Toxins, Type A) SB - IM MH - Botulinum Toxins, Type A/*adverse effects/therapeutic use MH - Cerebral Palsy/drug therapy MH - Drug-Related Side Effects and Adverse Reactions/*chemically induced MH - Humans MH - Infant MH - Neuromuscular Agents/*adverse effects/therapeutic use MH - Paralysis, Obstetric/drug therapy MH - Retrospective Studies MH - Severity of Illness Index MH - Spain MH - Spasm/drug therapy MH - Treatment Outcome EDAT- 2008/11/28 09:00 MHDA- 2010/01/15 06:00 CRDT- 2008/11/28 09:00 PHST- 2008/06/28 00:00 [received] PHST- 2008/09/28 00:00 [revised] PHST- 2008/10/07 00:00 [accepted] PHST- 2008/11/28 09:00 [pubmed] PHST- 2010/01/15 06:00 [medline] PHST- 2008/11/28 09:00 [entrez] AID - S1090-3798(08)00191-8 [pii] AID - 10.1016/j.ejpn.2008.10.006 [doi] PST - ppublish SO - Eur J Paediatr Neurol. 2009 Nov;13(6):511-5. doi: 10.1016/j.ejpn.2008.10.006. Epub 2008 Nov 25.