Second generation antipsychotics in ‘real-life’ paediatric patients. Adverse drug reactions and clinical outcomes of drug switch

Concetta Rafaniello, Marco Pozzi, Simone Pisano, Carmen Ferrajolo, Silvana Bertella, Liberata Sportiello, Carla Carnovale, Maria Giuseppa Sullo, Dario Cattaneo, Marta Gentili, Renata Rizzo, Antonio Pascotto, Elisa Mani, Laura Villa, Maria Pia Riccio, Serena Sperandeo, Renato Bernardini, Carmela Bravaccio, Emilio Giuseppe Ignazio Clementi, Massimo MolteniFrancesco Rossi, Sonia Radice, Annalisa Capuano

Research output: Contribution to journalArticlepeer-review


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.

Original languageEnglish
Pages (from-to)1-8
Number of pages8
JournalExpert Opinion on Drug Safety
Publication statusPublished - 2016


  • Adverse drug reactions
  • Aripiprazole
  • Pharmacovigilance
  • Risperidone
  • Secondgeneration antipsychotics

ASJC Scopus subject areas

  • Pharmacology (medical)


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