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Rafaniello, Concetta; Pozzi, Marco; Pisano, Simone; Ferrajolo, Carmen; Bertella, Silvana; Sportiello, Liberata; Carnovale, Carla; Sullo, Maria Giuseppa; Cattaneo, Dario; Gentili, Marta; Rizzo, Renata; Pascotto, Antonio; Mani, Elisa; Villa, Laura; Riccio, Maria Pia; Sperandeo, Serena; Bernardini, Renato; Bravaccio, Carmela; Clementi, Emilio; Molteni, Massimo; Rossi, Francesco; Radice, Sonia; Capuano, Annalisa
Expert opinion on drug safety, 12/2016, Volume: 15, Issue: sup2Journal Article
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.
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