title: Safety of botulinum toxin A in children and adolescents with cerebral palsy in a pragmatic setting.
abstract: This retrospective study aimed to examine the safety of botulinum toxin A (BoNT-A) treatment in a paediatric multidisciplinary cerebral palsy clinic. In a sample of 454 patients who had 1515 BoNT-A sessions, data on adverse events were available in 356 patients and 1382 sessions; 51 non-fatal adverse events were reported (3.3% of the total injections number, 8.7% of the patients). On five occasions, the adverse reactions observed in GMFCS V children were attributed to the sedation used (rectal midazolam plus pethidine; buccal midazolam) and resulted in prolongation of hospitalization. Of the reactions attributed to the toxin, 23 involved an excessive reduction of the muscle tone either of the injected limb(s) or generalized; others included local pain, restlessness, lethargy with pallor, disturbance in swallowing and speech production, seizures, strabismus, excessive sweating, constipation, vomiting, a flu-like syndrome and emerging hypertonus in adjacent muscles. Their incidence was associated with GMFCS level and with the presence of epilepsy (Odds ratio (OR) = 2.74 - p = 0.016 and OR = 2.35 - p = 0.046, respectively) but not with BoNT-A dose (either total or per kilogram). In conclusion, treatment with BoNT-A was safe; adverse reactions were mostly mild even for severely affected patients. Their appearance did not necessitate major changes in our practice.
authors.affiliation: Department of Neurology, Pendeli Children's Hospital, Athens, Greece. theon@otenet.gr
authors.forename: Antigone S
authors.initials: AS
authors.lastname: Papavasiliou
authors.forename: Irene
authors.initials: I
authors.lastname: Nikaina
authors.forename: Katerina
authors.initials: K
authors.lastname: Foska
authors.forename: Panagiotis
authors.initials: P
authors.lastname: Bouros
authors.forename: George
authors.initials: G
authors.lastname: Mitsou
authors.forename: Constantine
authors.initials: C
authors.lastname: Filiopoulos
mesh_terms: D000293:Adolescent; D016907:Adverse Drug Reaction Reporting Systems; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D002547:Cerebral Palsy / Q000188:drug therapy*; D002648:Child; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000209:etiology; D005260:Female; D006115:Greece; D006801:Humans; D015994:Incidence; D008297:Male; D009465:Neuromuscular Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D017410:Practice Guidelines as Topic; D012189:Retrospective Studies; D012720:Severity of Illness Index
chemical_list: D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A; C542869:abobotulinumtoxinA