Article

The aim of this study was to assess the risk of adverse drug reactions
(ADRs) with botulinum neurotoxin type A (BoNT-A) in children with cerebral palsy
(CP) using the World Health Organization global individual case safety report
(ICSR) database, VigiBase. METHOD: We extracted all children ICSRs for ADRs with
BoNT-A used as anti-spastic drug in CP recorded between 1995 and 2015 in
VigiBase. We also performed a case/non-case method (disproportionality analysis)
to assess the link between exposure to BoNT-A and each ADR of interest in
children and adults, calculating reporting odds ratios (RORs). RESULTS: In
VigiBase, 162 ICSRs were registered. They involved mainly males (n=95, 59%) and
mean (SD) age was 7 years 11 months (4y 4mo). The most frequent ADR was dysphagia
(27 ICSRs, 17%) followed by asthenia and muscular weakness (25 ICSRs each, 16%).
Nineteen ICSRs (12%) were lethal. There was a significant association between
BoNT-A and death in children (ROR=11.1 95%, confidence interval [CI] 7.0-17.7)
but not in adults. INTERPRETATION: In children with CP, most ADRs seem to be
linked to a systemic spread of BoNT-A. Our study suggests a higher risk of ADRs
with BoNT-A in children than in adults.
CI - (c) 2016 Mac Keith Press.

Langue : ANGLAIS