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

Abstract

AIM:

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.

• Authors: Jeanne Montastruc, Philippe Marque, Florence Moulis, Véronique Bourg, Valérie Lambert, Geneviève Durrieu, Jean-Louis Montastruc, François Montastruc
• Journal: Developmental medicine and child neurology (Dev Med Child Neurol) Vol. 59 Issue 3 Pg. 329-334 (03 2017) ISSN: 1469-8749 [Electronic] England
• PMID: 27682175 (Publication Type: Journal Article)
• Copyright: © 2016 Mac Keith Press.

Chemical References

• Neuromuscular Agents
• Botulinum Toxins, Type A

Topics

• Adolescent
• Botulinum Toxins, Type A (therapeutic use)
• Cerebral Palsy (drug therapy, epidemiology)
• Child
• Child, Preschool
• Databases, Factual
• Drug-Related Side Effects and Adverse Reactions (etiology)
• Epidemiologic Studies
• Female
• Humans
• Infant
• Longitudinal Studies
• Male
• Neuromuscular Agents (therapeutic use)
• Retrospective Studies