title: Onabotulinumtoxin A injections: a safety review of children with clubfoot under 2 years of age at BC Children's Hospital.
abstract: BACKGROUND
  Pediatric indications for Onabotulinumtoxin A extend beyond treatment of skeletal muscle conditions. Each of the indications for Onabotulinumtoxin A use have adverse events reported in the past. The aim of this study was to review dverse events in children less than 2 years of age who were treated with Onabotulinumtoxin A injections as part of equinus foot deformity, in the setting of clubfoot at British Columbia's Children Hospital.
  
  
  METHODS
  A retrospective review of all clubfoot patients at British Columbia's Children Hospital, less than 2 years of age, who received a Onabotulinumtoxin A injection for equinus correction, between September 2000 and December 2012 was conducted. Data collected included demographics, clinical diagnosis, treatment history, ankle range of motion and any adverse event noted by the clubfoot team or reported by the families.
  
  
  RESULTS
  A total of 239 eligible subjects (361 feet) had received 523 Onabotulinumtoxin A injections before the age of 2 years. There was only one adverse event reported out of the 523 Onabotulinumtoxin A injections (adverse events rate of 0.19%) given at British Columbia's Children Hospital. However, this adverse event was not found related to the Onabotulinumtoxin A injection.
  
  
  CONCLUSIONS
  Onabotulinumtoxin A appears to be safe with respect to the adverse events, for use in children under 2 years of age with the diagnosis of clubfoot when dosed at 10 units per kilogram. However, the dose of Onabotulinumtoxin A and underlying diagnosis should always be kept in mind.
authors.affiliation: Department of Orthopaedics, BC Children's Hospital, Vancouver, BC, Canada. Electronic address: hchhina@cw.bc.ca.
authors.forename: Harpreet
authors.initials: H
authors.lastname: Chhina
authors.affiliation: Department of Orthopaedics, BC Children's Hospital, Vancouver, BC, Canada.
authors.forename: Alyssa
authors.initials: A
authors.lastname: Howren
authors.affiliation: Department of Orthopaedics, BC Children's Hospital, Vancouver, BC, Canada.
authors.forename: Andrea
authors.initials: A
authors.lastname: Simmonds
authors.affiliation: Department of Orthopaedics, BC Children's Hospital, Vancouver, BC, Canada.
authors.forename: Christine M
authors.initials: CM
authors.lastname: Alvarez
mesh_terms: D019274:Botulinum Toxins, Type A / Q000009:adverse effects*; D002675:Child, Preschool; D003025:Clubfoot / Q000188:drug therapy*; D005260:Female; D006776:Hospitals, Pediatric / Q000706:statistics & numerical data; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D009465:Neuromuscular Agents / Q000009:adverse effects*; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A
keywords: Adverse events; Botulinum toxin type A; Children; Clubfoot; Safety review