Adverse events and health status following botulinum toxin type A injections in children with cerebral palsy.
OBJECTIVE
The aim of this study was to assess changes in health status before and after, as well as adverse events after, botulinum toxin type A (BoNT-A) injections in children with cerebral palsy (CP).


METHODS
A total of 334 children (190 male; 144 female) aged 1y 6mo to 19y 4mo (mean 9y 2mo, SD 4y) with CP who were undergoing BoNT-A injections (596 injection courses in total) were clinically audited over a 16-month period. Of the 334 children, 62 were classified at Gross Motor Function Classification System (GMFCS) level I, 52 of whom had unilateral CP and 10 of whom had bilateral CP. Eighty-six children were classified at GMFCS level II, 39 of whom had unilateral CP and 47 of whom had bilateral CP. Forty-four children were classified at GMFCS level III, two of whom had unilateral CP and 42 of whom had bilateral CP. Sixty-six of the 334 children were classified at GMFCS level IV and 76 as level V. All the children classified as level IV or V had bilateral involvement. The health status of the children in the month before and a prospective audit of health status and adverse events in the month after BoNT-A injections were examined in order to assess the effects of the toxin.


RESULTS
The data gathered for the month before administration of BoNT-A indicated that children with CP had significant background morbidities. After injection of BoNT-A, adverse events occurred in 23.2% of children. All adverse events were temporary and there were no deaths.


CONCLUSIONS
The results of this audit indicate that there is insufficient evidence to warrant restriction of the administration of BoNT-A in children with CP at any GMFCS level in our service.
Kids Rehab, The Children's Hospital at Westmead, Westmead, NSW, Australia.
Stephen J
SJ
O'Flaherty
Vyshnavi
V
Janakan
Angela M
AM
Morrow
Adam M
AM
Scheinberg
Mary-Clare A
MC
Waugh
D000293:Adolescent; D016907:Adverse Drug Reaction Reporting Systems; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage / Q000009:adverse effects*; D002547:Cerebral Palsy / Q000145:classification / Q000453:epidemiology / Q000534:rehabilitation*; D002648:Child; D002675:Child, Preschool; D015897:Comorbidity; D003680:Deglutition Disorders / Q000139:chemically induced; D004185:Disability Evaluation; D004305:Dose-Response Relationship, Drug; D005242:Fecal Incontinence / Q000139:chemically induced; D005260:Female; D006304:Health Status; D006801:Humans; D007223:Infant; D007273:Injections, Intramuscular; D057045:Laryngopharyngeal Reflux / Q000139:chemically induced; D008297:Male; D009517:New South Wales; D012141:Respiratory Tract Infections / Q000139:chemically induced; D012189:Retrospective Studies; D012307:Risk Factors; D014481:United States; D014486:United States Food and Drug Administration; D014549:Urinary Incontinence / Q000139:chemically induced
D019274:Botulinum Toxins, Type A