A Systematic Review and a VigiBase Study of Accidental Clozapine Intoxications in Children and Adolescents

OBJECTIVES: This study aimed to: (1) systematically review published cases of accidental clozapine poisoning in children and adolescents, and (2) study accidental pediatric clozapine intoxications reported to VigiBase, the global pharmacovigilance database. METHODS: A systematic review was conducted following PRISMA guidelines, and a retrospective analysis of accidental pediatric clozapine intoxication cases was performed using VigiBase. RESULTS: A systematic review identified 5 studies describing 8 cases of accidental clozapine ingestion in children aged 10 months to 10 years. The most common clinical manifestations were acute neuro-respiratory complications. One fatality was reported, in a two-year-old child. The VigiBase observational analysis included 32 accidental intoxication cases, 3 in adolescents and 29 in children under seven years of age. Among adolescents, all cases resulted from in-hospital medication administration errors; none were fatal. In the children, nearly half required prolonged hospitalization, and 2 resulted in death due to aspiration pneumonia or cardiopulmonary failure. CONCLUSIONS: Accidental clozapine poisoning in pediatric populations, although rare, can result in severe and potentially life-threatening outcomes, particularly in very young children. At home, preventive strategies are essential to reduce accidental overdose. The 3 cases of hospitalized adolescents are relatively recent, and many hospitals currently have systems in place to prevent medication errors.