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A Journal on Pediatrics, Neonatology, Adolescent Medicine,
Child and Adolescent Psychiatry

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Minerva Pediatrica 2014 June;66(3):187-99

language: Italian

Safety and tolerability of psychotropic medications in childhood: preliminary data of a pharmacovigilance study

Magazù A. 1, Masi G. 3, Germanò E. 2, Gagliostro M. S. 1, Siracusano R. 2, Arcoraci V. 1, Spina E. 1, Gagliano A. 2

1 Dipartimento Clinico‑Sperimentale di Medicina e Farmacologia, Università di Messina, Messina, Italia;
2 Unità Operativa Complessa di Neuropsichiatria Infantile, Università di Messina, Messina, Italia;
3 IRCCS Fondazione Stella Maris, Calambrone, Pisa, Italia


AIM: The aim of this study was to evaluate adverse drug reactions (ADRs) of psychotropic medications in childhood.
METHODS: One hundred and two children and adolescents (M 82.4%, F 17.6%) followed-up at the Division of Child Neurology and Psychiatry at the University of Messina, and at the Scientific Institute Child Neurology and Psychiatry, IRCCS Stella Maris, Calambrone, Pisa, were recruited between January 2009 and December 2011. All participants met DSM-IV diagnostic criteria for psychiatric disorders. The data were collected using a recording sheet for ADRs. An electronic database was also used. The recording sheet was designed to note all relevant information about drug treatment and ADRs according to AIFA (Agenzia Italiana del Farmaco) suggestions.
RESULTS: The most prescribed drugs were: risperidone (19.6%), aripiprazole (18.4%) and valproic acid (14.8%). The ADRs more frequently recorded had been: weight gain (12.6%), sleepiness (8.4%), and irritability (6.7%). None of recorded ADRs were classified as “serious”.
CONCLUSION: This study can provide a basic model to collect information on safety and tolerability of psychotropic drugs in childhood.

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