title: Safety of high-dose botulinum toxin type A therapy for the treatment of pediatric spasticity.
abstract: This retrospective chart review examines the safety of high-dose (> or = 15 U/kg body weight or > or = 800 total units) botulinum toxin type A (BOTOX, Allergan Inc., Irvine, CA) in children and young adults with spasticity. Ninety-four children weighing < 45 kg received a mean total dose of 334.1 U or 19.1 U/kg. Fourteen young adults weighing > or = 45 kg received a mean total dose of 927.3 U or 15.2 U/kg. Adverse events were reported by 3 of the 108 patients (2.8%) and included single instances of rash and enuresis. The only serious adverse event consisted of mild, generalized botulism in a 13-year-old patient who received a 23 U/kg dose to the hamstrings and gastrocnemius/soleus bilaterally. No serious adverse events were noted in children weighing < 45 kg who received botulinum toxin type A doses of 15 to 22 U/kg of body weight or in young adults > or = 45 kg who received total doses of 800 to 1200 U in a single injection protocol. High-dose botulinum toxin type A is safe for the treatment of spasticity in children and young adults.
authors.affiliation: Child Neurology Associates, Children's Healthcare of Atlanta at Scottish Rite Children's Medical Center, Marcus Institute Division of Child Neurology, Atlanta, GA 30342, USA. egoldstein@childneuro.org
authors.forename: Edward M
authors.initials: EM
authors.lastname: Goldstein
mesh_terms: D000293:Adolescent; D000328:Adult; D019274:Botulinum Toxins, Type A / Q000009:adverse effects* / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D035002:Lower Extremity; D009128:Muscle Spasticity / Q000188:drug therapy*; D009465:Neuromuscular Agents / Q000009:adverse effects* / Q000627:therapeutic use; D012189:Retrospective Studies; D034941:Upper Extremity
chemical_list: D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A