Adverse drug reactions of botulinum neurotoxin type A in children with cerebral palsy: a pharmaco‐epidemiological study in VigiBase

Aim The aim of this study was to assess the risk of adverse drug reactions ( ADR s) with botulinum neurotoxin type A (Bo NT ‐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 ICSR s for ADR s with Bo NT ‐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 Bo NT ‐A and each ADR of interest in children and adults, calculating reporting odds ratios ( ROR s). Results In VigiBase, 162 ICSR s 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 ICSR s, 17%) followed by asthenia and muscular weakness (25 ICSR s each, 16%). Nineteen ICSR s (12%) were lethal. There was a significant association between Bo NT ‐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 ADR s seem to be linked to a systemic spread of Bo NT ‐A. Our study suggests a higher risk of ADR s with Bo NT ‐A in children than in adults.