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

Samuel Ignacio Pascual-Pascual1, Ignacio Pascual-Castroviejo

  • 1Pediatric Neurology Service, University Hospital La Paz, Paseo de la Castellana 261, 28046 Madrid, Spain. ipascualp.hulp@salud.madrid.org

European Journal of Paediatric Neurology : EJPN : Official Journal of the European Paediatric Neurology Society
|November 28, 2008
PubMed

Insights

Botulinum toxin type A (BoNT-A) is safe for infants under two years old, with mild side effects like temporary weakness. This study confirms its good safety profile in young children, similar to older patients.

Area of Science:

  • Pediatric Neurology
  • Pharmacology
  • Clinical Trials

Background:

  • Botulinum toxin type A (BoNT-A) is approved for spasticity in children over 2 years old.
  • Limited data exists on BoNT-A use in infants under 2 years.

Purpose of the Study:

  • To retrospectively evaluate the safety of BoNT-A in infants under 2 years old.
  • To analyze adverse events in this young patient population.

Main Methods:

  • Retrospective review of 74 infants treated with BoNT-A.
  • Infants were divided into two groups: under 1 year and 1-2 years old.
  • Data on indications, dosages (Botox, Dysport), and adverse events were collected.

Main Results:

  • Common indications included obstetric brachial palsy (OBP) and cerebral palsy (CP).
  • Adverse events were infrequent (3.6% in the first year, 6.5% in the second year).
  • Reported adverse events were mild weakness or tiredness, resolving within 1-4 days.

Conclusions:

  • BoNT-A demonstrates a favorable safety profile in infants under 2 years old.
  • Adverse events observed are comparable to those in older pediatric populations.
  • BoNT-A is a safe treatment option for infants requiring management of conditions like spasticity.
Abstract

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