title: Second generation antipsychotics in 'real-life' paediatric patients. Adverse drug reactions and clinical outcomes of drug switch.
abstract: OBJECTIVE
  Gap in knowledge on benefit/risk ratio of second generation antipsychotics (SGA) in the paediatric population represents a challenge for the scientific community. This study aims to analyse all suspected adverse drug reactions (ADRs) to SGA observed during the study period; compare the safety profiles of risperidone and aripiprazole; evaluate the effect of switching from risperidone to aripiprazole or to a first generation antipsychotic (FGA).
  
  
  METHODS
  Prospective analysis of spontaneously reported ADRs concerning 184 paediatric outpatients between 2012 and 2014.; clinical outcomes of drug switch were evaluated.
  
  
  RESULTS
  Out of the 184 patients, 130 experienced at least one ADR; ADRs were usually not serious and more frequently associated with aripiprazole. Switching to aripiprazole was associated with better results than switching to FGAs in the Clinical Global Impression scale- Efficacy (CGI-E) scores (p = 0.018), Disturbed behaviour checklist-parents (DBC-P) self-absorption subscale (p = 0.010); only a trend for difference between changing to aripiprazole vs FGAs in the DBC-P total score (p = 0.054) and social relating subscale (p = 0.053) was observed.
  
  
  CONCLUSIONS
  SGAs safety data were consistent with the ones already known; however, there is still a need to improve the knowledge in pharmacovigilance field among clinicians. Switching to aripiprazole may be a valid alternative to risperidone.
authors.affiliation: a Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, Department of Experimental Medicine, Section of Pharmacology L. Donatelli, School of Medicine and Surgery , Second University of Naples , Naples , Italy.
authors.forename: Concetta
authors.initials: C
authors.lastname: Rafaniello
authors.affiliation: b Scientific Institute IRCCS Eugenio Medea , Bosisio Parini, Lecco , Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Pozzi
authors.affiliation: c Department of Mental and Physical Health and Preventive Medicine, Child and Adolescent Psychiatry Division , Second University of Naples , Naples , Italy.
authors.forename: Simone
authors.initials: S
authors.lastname: Pisano
authors.affiliation: a Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, Department of Experimental Medicine, Section of Pharmacology L. Donatelli, School of Medicine and Surgery , Second University of Naples , Naples , Italy.
authors.forename: Carmen
authors.initials: C
authors.lastname: Ferrajolo
authors.affiliation: b Scientific Institute IRCCS Eugenio Medea , Bosisio Parini, Lecco , Italy.
authors.forename: Silvana
authors.initials: S
authors.lastname: Bertella
authors.affiliation: a Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, Department of Experimental Medicine, Section of Pharmacology L. Donatelli, School of Medicine and Surgery , Second University of Naples , Naples , Italy.
authors.forename: Liberata
authors.initials: L
authors.lastname: Sportiello
authors.affiliation: d Unit of Clinical Pharmacology, Department of Biomedical and Clinical Sciences L. Sacco , L. Sacco University Hospital, Università di Milano , Milan , Italy.
authors.forename: Carla
authors.initials: C
authors.lastname: Carnovale
authors.affiliation: a Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, Department of Experimental Medicine, Section of Pharmacology L. Donatelli, School of Medicine and Surgery , Second University of Naples , Naples , Italy.
authors.forename: Maria Giuseppa
authors.initials: MG
authors.lastname: Sullo
authors.affiliation: d Unit of Clinical Pharmacology, Department of Biomedical and Clinical Sciences L. Sacco , L. Sacco University Hospital, Università di Milano , Milan , Italy.
authors.forename: Dario
authors.initials: D
authors.lastname: Cattaneo
authors.affiliation: d Unit of Clinical Pharmacology, Department of Biomedical and Clinical Sciences L. Sacco , L. Sacco University Hospital, Università di Milano , Milan , Italy.
authors.forename: Marta
authors.initials: M
authors.lastname: Gentili
authors.affiliation: e Child and Adolescent Neuropsychiatry, Department of Medical and Paediatric Sciences, School of Medicine , University of Catania , Catania , Italy.
authors.forename: Renata
authors.initials: R
authors.lastname: Rizzo
authors.affiliation: c Department of Mental and Physical Health and Preventive Medicine, Child and Adolescent Psychiatry Division , Second University of Naples , Naples , Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Pascotto
authors.affiliation: b Scientific Institute IRCCS Eugenio Medea , Bosisio Parini, Lecco , Italy.
authors.forename: Elisa
authors.initials: E
authors.lastname: Mani
authors.affiliation: b Scientific Institute IRCCS Eugenio Medea , Bosisio Parini, Lecco , Italy.
authors.forename: Laura
authors.initials: L
authors.lastname: Villa
authors.affiliation: c Department of Mental and Physical Health and Preventive Medicine, Child and Adolescent Psychiatry Division , Second University of Naples , Naples , Italy.
authors.forename: Maria Pia
authors.initials: MP
authors.lastname: Riccio
authors.affiliation: c Department of Mental and Physical Health and Preventive Medicine, Child and Adolescent Psychiatry Division , Second University of Naples , Naples , Italy.
authors.forename: Serena
authors.initials: S
authors.lastname: Sperandeo
authors.affiliation: f Department of Clinical and Molecular Biomedicine, Section of Pharmacology and Biochemistry, School of Medicine , University of Catania , Catania , Italy.
authors.forename: Renato
authors.initials: R
authors.lastname: Bernardini
authors.affiliation: g Department of Translational Medical Sciences , University Federico II of Naples , Naples , Italy.
authors.forename: Carmela
authors.initials: C
authors.lastname: Bravaccio
authors.affiliation: b Scientific Institute IRCCS Eugenio Medea , Bosisio Parini, Lecco , Italy.|d Unit of Clinical Pharmacology, Department of Biomedical and Clinical Sciences L. Sacco , L. Sacco University Hospital, Università di Milano , Milan , Italy.
authors.forename: Emilio
authors.initials: E
authors.lastname: Clementi
authors.affiliation: b Scientific Institute IRCCS Eugenio Medea , Bosisio Parini, Lecco , Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Molteni
authors.affiliation: a Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, Department of Experimental Medicine, Section of Pharmacology L. Donatelli, School of Medicine and Surgery , Second University of Naples , Naples , Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Rossi
authors.affiliation: d Unit of Clinical Pharmacology, Department of Biomedical and Clinical Sciences L. Sacco , L. Sacco University Hospital, Università di Milano , Milan , Italy.
authors.forename: Sonia
authors.initials: S
authors.lastname: Radice
authors.affiliation: a Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, Department of Experimental Medicine, Section of Pharmacology L. Donatelli, School of Medicine and Surgery , Second University of Naples , Naples , Italy.
authors.forename: Annalisa
authors.initials: A
authors.lastname: Capuano
mesh_terms: D000293:Adolescent; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D000068180:Aripiprazole / Q000008:administration & dosage / Q000009:adverse effects*; D002648:Child; D057915:Drug Substitution; D005260:Female; D006801:Humans; D008297:Male; D011446:Prospective Studies; D011569:Psychiatric Status Rating Scales; D018967:Risperidone / Q000008:administration & dosage / Q000009:adverse effects*
chemical_list: D014150:Antipsychotic Agents; D000068180:Aripiprazole; D018967:Risperidone
keywords: Adverse drug reactions; aripiprazole; pharmacovigilance; risperidone; second-generation antipsychotics