Safety of botulinum toxin type A in children younger than 2 years.
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.


OBJECTIVE
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.
Pascual-Pascual
Samuel Ignacio
SI
Pediatric Neurology Service, University Hospital La Paz, Paseo de la Castellana 261, 28046 Madrid, Spain. ipascualp.hulp@salud.madrid.org
Pascual-Castroviejo
Ignacio
I
D019274:Botulinum Toxins, Type A / Q000009:adverse effects* / Q000627:therapeutic use; D002547:Cerebral Palsy / Q000188:drug therapy; D064420:Drug-Related Side Effects and Adverse Reactions / Q000139:chemically induced*; D006801:Humans; D007223:Infant; D009465:Neuromuscular Agents / Q000009:adverse effects* / Q000627:therapeutic use; D010246:Paralysis, Obstetric / Q000188:drug therapy; D012189:Retrospective Studies; D012720:Severity of Illness Index; D013030:Spain; D013035:Spasm / Q000188:drug therapy; D016896:Treatment Outcome
D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A