title: Preliminary and ongoing French multicenter prospective naturalistic study of adverse events of antipsychotic treatment in naive children and adolescents.
abstract: BACKGROUND
  The prescription of antipsychotics (AP), and especially second generation AP, is increasing worldwide in the pediatric population. Most prescriptions are off-label and despite the identification of frequent and potentially severe adverse events (AE), there are only a few guidelines for the safety management. France is one of the countries with no official safety guidelines.
  
  
  METHODS
  Psychotropic drug-naive adolescents (13-18 years), hospitalized for an acute psychotic episode and treated with a second-generation antipsychotic were consecutively included in a prospective cohort study. Patients were assessed for their AE at baseline, 2, 6 and 12 weeks after the introduction of drug.
  
  
  RESULTS
  The majority of patients was treated with risperidone (n = 13), 2 with aripiprazole. The principal findings are: (1) A high incidence of neuromuscular AE: 8/15 muscle weakness, 8/15 extrapyramidal syndrome, 6/15 akathisia, 3/15 oro-facial acute dystonia; (2) Severe catatonia symptoms in 2 patients despite a low to moderate treatment dose, requiring transfer in intensive care unit for one; (3) Weight gain and significant increase of the BMI for all 13 patients who had a 12 weeks follow-up.
  
  
  CONCLUSIONS
  All adolescents experienced AE, with significant weight gain being observed in all patients who completed the 12-week follow-up. The fact that our patient population was first episode drug naïve may partially explain this observation. Despite the limitation due to the small sample size of this prospective short-term study, such findings are important to report and warrant further research.
  Because of the lack of naturalistic follow up studies of antipsychotic treatments in AP-naive children and adolescents and the absence of safety guidelines for the pediatric population in France, we decided to continue our research at a national level. We therefore started a prospective, naturalistic and multicenter study funded by the French National Agency for Medicines and Health Products Safety (ANSM). Study purpose is to evaluate the incidence of adverse events related to antipsychotic drugs in AP-naive children and adolescents. In addition, we aim to provide further evidence for the necessity of national safety guidelines for AP prescription in the pediatric population.
authors.affiliation: University Department of Child and Adolescent Psychiatry, Nice Children's Hospitals CHU-Lenval, 57 avenue de la Californie, 06200 Nice, France.
authors.forename: Marie-Line
authors.initials: ML
authors.lastname: Menard
authors.affiliation: University Department of Child and Adolescent Psychiatry, Nice Children's Hospitals CHU-Lenval, 57 avenue de la Californie, 06200 Nice, France.
authors.forename: Susanne
authors.initials: S
authors.lastname: Thümmler
authors.affiliation: Paediatrics and CDC, Lundbeck SAS, 92445 Issy-les-Moulineaux, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Auby
authors.affiliation: University Department of Child and Adolescent Psychiatry, Nice Children's Hospitals CHU-Lenval, 57 avenue de la Californie, 06200 Nice, France.
authors.forename: Florence
authors.initials: F
authors.lastname: Askenazy
keywords: Adverse drug events; Antipsychotics; Child psychiatry; Drug-naïve population; Pediatrics; Therapeutic drug monitoring