[Improve safety monitoring of antipsychotics in the French pediatric population]

M-L Menard1, F Askenazy1, P Auby2

  • 1Service universitaire de psychiatrie de l'enfant et de l'adolescent, hôpitaux pédiatriques de Nice, CHU Lenval, 57, avenue de la Californie, 06200 Nice, France.

Insights

The ETAPE study monitors adverse events in children prescribed antipsychotics, addressing a critical lack of safety data in France. This research aims to improve prescribing decisions and enhance drug safety for young patients.

Area of Science:

  • Pharmacovigilance in child and adolescent psychiatry.
  • Pediatric psychopharmacology and adverse event monitoring.

Context:

  • Rising prescription rates of second-generation antipsychotics in pediatric populations globally and in France.
  • Limited safety data and relevant methodological tools for pediatric antipsychotic use in France compared to other nations.
  • Identification of potentially serious adverse events in young patients, including neuromuscular, metabolic, and cardiovascular issues.

Purpose:

  • To report current French and international knowledge on antipsychotic use in pediatric populations.
  • To introduce the ETAPE study, a safety monitoring procedure for antipsychotic-naive pediatric patients.
  • To determine the incidence of adverse events associated with antipsychotic drugs in this vulnerable group.

Summary:

  • The ETAPE study involves 12-month safety monitoring with clinical and laboratory assessments at predefined intervals (pre-treatment, 1, 3, 6, 9, 12 months).
  • The study focuses on antipsychotic-naive pediatric patients to accurately capture incident adverse events.
  • Funding was provided by the National Security Agency of Medicines (ANSM 2012 No. 40).

Impact:

  • Contribute to educating healthcare practitioners on pediatric antipsychotic adverse events.
  • Aid prescribers in making informed decisions regarding antipsychotic drug selection and management in children.
  • Reinforce France's adverse event monitoring system for atypical antipsychotics and inform recommendations for improved pediatric safety.

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