title: [Improve safety monitoring of antipsychotics in the French pediatric population].
abstract: In France, as in the rest of the world, the prescription of second generation antipsychotics is on the rise in the pediatric population. At the same time, the use of first generation antipsychotics continues, although it is declining in France as in other countries. In France, we lack data on the pediatric population to ensure a safe prescription, unlike other countries such as Canada and the United States. This is disturbing when many adverse events, potentially serious for young patients' health (neuromuscular complications, risk factors, cardiovascular problems) are beginning to be identified. This article reports the current French and international knowledge on antipsychotics in the pediatric population. It appears that data in the French population are nearly nonexistent and that the methodological tools used are not always relevant (population already exposed to psychotropic drugs, short studies, debatable rating scale and somatic parameters). Within this context, a safety monitoring procedure for the naive pediatric population treated with antipsychotics was developed (ETAPE study) to determine the incidence of adverse events appearing with these drugs. Safety monitoring during the 12-month study period will include clinical assessments and laboratory testing. These assessments will be performed before treatment and at 1, 3, 6, 9, and 12 months after the introduction of the antipsychotic drug. This study received funding from the National Security Agency of Medicines (ANSM 2012 No. 40). The results should contribute to educating all practitioners (general physicians, pediatricians, psychiatrists, child psychiatrists) on adverse events, helping practitioners with prescribing decisions, reinforcing the French system of monitoring adverse events caused by atypical antipsychotic drugs, and developing recommendations to improve the safety of atypical antipsychotic drugs in child psychiatry.
authors.affiliation: Service universitaire de psychiatrie de l'enfant et de l'adolescent, hôpitaux pédiatriques de Nice, CHU Lenval, 57, avenue de la Californie, 06200 Nice, France. Electronic address: ml.menard@pediatrie-chulenval-nice.fr.
authors.forename: M-L
authors.initials: ML
authors.lastname: Menard
authors.affiliation: Service universitaire de psychiatrie de l'enfant et de l'adolescent, hôpitaux pédiatriques de Nice, CHU Lenval, 57, avenue de la Californie, 06200 Nice, France.
authors.forename: F
authors.initials: F
authors.lastname: Askenazy
authors.affiliation: Département recherche clinique international pédiatrique de Lundbeck, participation indépendante du laboratoire, 37-45, quai du Président-Roosevelt, 92445 Issy-les-Moulineaux, France.
authors.forename: P
authors.initials: P
authors.lastname: Auby
authors.affiliation: Service universitaire de psychiatrie de l'enfant et de l'adolescent, CHU de Nantes, 7, quai Moncousu, 44093 Nantes, France.
authors.forename: O
authors.initials: O
authors.lastname: Bonnot
authors.affiliation: Service universitaire de psychiatrie de l'enfant et de l'adolescent, hôpital de la Pitié-Salpêtrière, 47-83, boulevard de l'Hôpital, 75013 Paris XIII, France.
authors.forename: D
authors.initials: D
authors.lastname: Cohen
mesh_terms: D000293:Adolescent; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D002648:Child; D016903:Drug Monitoring; D005602:France; D006801:Humans; D001523:Mental Disorders / Q000188:drug therapy; D010372:Pediatrics; D011159:Population Surveillance
chemical_list: D014150:Antipsychotic Agents