ABSTRACT
Title
Post-marketing drug surveillance of psychotropic drugs: a pilot study in a pediatric setting
Authors
M.S. Gagliostro1, A. Magazù2, V. Arcoraci1, P. Cutroneo1, A. Gagliano2, E. Germanò2, R. Siracusano2, G. Masi3, E. Spina1.
1Department of Clinical and Experimental Medicine and Pharmacology, Pharmacology Unit, University of Messina, 2Division of Child Neurology and Psychiatry, University of Messina, Messina, and 3IRCCS Stella Maris, Scientific Institute of Child Neurology and Psychiatry, Calambrone (Pisa), Italy
1Department of Clinical and Experimental Medicine and Pharmacology, Pharmacology Unit, University of Messina, 2Division of Child Neurology and Psychiatry, University of Messina, Messina, and 3IRCCS Stella Maris, Scientific Institute of Child Neurology and Psychiatry, Calambrone (Pisa), Italy
Abstract
Over the past decade, an increased use of psychotropic drugs, in particular newer antipsychotics and antidepressants, has been reported in children and adolescents. However, there is a growing concern about safety of these agents in pediatric settings since psychotropic medications are commonly prescribed off-label. Aim of the present pilot study was to conduct a prospective pharmacovigilance investigation to monitor adverse drug reactions (ADRs) associated with psychotropic drugs in a pediatric population.
Children and adolescents, outpatients or inpatients attwo Child Neurology and Psychiatry Units,who started a treatment with antipsychotics, antidepressants or mood stabilizers in the period June 2010-December 2010, were followed prospectively. Data were collected by the use of a specific form including demographic and clinical data of the participants.
Seventy-nine patients (64 males and 15 females; mean age at baseline 12.6 ± 3.0 years for females and 11.8 ± 3.4 for males) were monitored during the study period. The most common psychiatric diagnoses according to DSM-IV were, pervasive developmental disorder (31.6%), attention deficit hyperactivity disorder (30.4%), mood disorders (27.8%) and obsessive-compulsive disorder (26.6%). Second-generation antipsychotics were the most commonly prescribed psychotropic drugs. Forty-five patients received risperidone, 37 aripiprazole, 7 olanzapine and 5 quetiapine. Of the 18 patients treated with selective serotonin reuptake inhibitors, 9 were receiving sertraline. Seven patients were treated with methylphenidate. Drugs were occasionally given in combination. The total number of ADRs observed during the study period was 110. Thirty-seven patients (46.8%) experienced at least one ADR. The most commonly reported ADRs were weight gain (14 pts), sedation (12 pts), irritability (8 pts) and increased appetite (6 pts). Drugs more frequently responsible for ADRs were: risperidone (n=37), aripiprazole (n=18), sertraline (n=8) and methylphenidate (n=7). Seven ADRs (6.4%) were considered serious.
The reported data are preliminary and the study is still ongoing. The type and frequency of ADRs appear to be consistent with the use of these drugs in this age group. This pilot study raised many methodological issues which should be addressed for the study to be extended to other centers.
Children and adolescents, outpatients or inpatients attwo Child Neurology and Psychiatry Units,who started a treatment with antipsychotics, antidepressants or mood stabilizers in the period June 2010-December 2010, were followed prospectively. Data were collected by the use of a specific form including demographic and clinical data of the participants.
Seventy-nine patients (64 males and 15 females; mean age at baseline 12.6 ± 3.0 years for females and 11.8 ± 3.4 for males) were monitored during the study period. The most common psychiatric diagnoses according to DSM-IV were, pervasive developmental disorder (31.6%), attention deficit hyperactivity disorder (30.4%), mood disorders (27.8%) and obsessive-compulsive disorder (26.6%). Second-generation antipsychotics were the most commonly prescribed psychotropic drugs. Forty-five patients received risperidone, 37 aripiprazole, 7 olanzapine and 5 quetiapine. Of the 18 patients treated with selective serotonin reuptake inhibitors, 9 were receiving sertraline. Seven patients were treated with methylphenidate. Drugs were occasionally given in combination. The total number of ADRs observed during the study period was 110. Thirty-seven patients (46.8%) experienced at least one ADR. The most commonly reported ADRs were weight gain (14 pts), sedation (12 pts), irritability (8 pts) and increased appetite (6 pts). Drugs more frequently responsible for ADRs were: risperidone (n=37), aripiprazole (n=18), sertraline (n=8) and methylphenidate (n=7). Seven ADRs (6.4%) were considered serious.
The reported data are preliminary and the study is still ongoing. The type and frequency of ADRs appear to be consistent with the use of these drugs in this age group. This pilot study raised many methodological issues which should be addressed for the study to be extended to other centers.