Tolerability and safety profile of risperidone in a sample of children and adolescents

Abstract

The aim of this prospective observational study was to verify the tolerability and safety profile of risperidone in a sample of antipsychotic-naive children/adolescent patients having a different psychiatric diagnosis. Twenty-two (mean age of 12±3.2) antipsychotic-naive patients who started therapy with risperidone were recruited. The assessment involved anthropometric data (weight, height, BMI, BMI z-score and BMI percentile), cardiovascular parameters (blood pressure and QTc interval) and blood tests (levels of glucose, triglycerides, total cholesterol, glutamic oxaloacetic and pyruvic transaminases, γ-glutamyl transferase, prolactin, free triiodothyronine, free thyroxine, thyroid-stimulating hormone, thyroglobulin, antithyroid peroxidase and antithyroglobulin). After an average follow-up of 6 months of risperidone therapy, a statistically significant increase in weight and body composition was observed. Furthermore, an increase in serum levels of prolactin was observed in 50% of patients. No other significant changes in metabolic and cardiovascular parameters were found. Although an increase in these parameters was detected, it remained in the normal range. This study suggests the use of specific protocols for monitoring children/adolescents treated with second-generation antipsychotics to manage the metabolic long-term complications and progression to more severe disease states.

Adherence to Guidelines for Glucose Assessment in Starting Second-Generation Antipsychotics

“…7 Andrade et al 8 reported an increased rate of diabetes among 5 to 18 year olds exposed to SGAs; however, findings were inconsistent and depended on the comparison group. Margari et al 9 found a nonsignificant increase in blood glucose in a small study of antipsychoticnaïve children and adolescents starting risperidone. There is little comparative data on the risk of hyperglycemia and type 2 diabetes mellitus in youth treated with various SGAs.…”

Risperidone-induced weight gain and reduced locomotor activity in juvenile female rats: The role of histaminergic and NPY pathways

“…The majority of antipsychotic drugs prescribed in children and adolescents are second generation antipsychotics (SGAs) including risperidone and olanzapine, which have serious weight gain and other metabolic side-effects [5][6][7][8][9][10]. Of even greater concern, however, is evidence clearly demonstrating that the paediatric population appears to be at greater risk than adults for SGA-induced weight gain and metabolic side-effects [11].…”

9‐Hydroxyrisperidone‐Induced Hyperprolactinaemia in Thai Children and Adolescents with Autism Spectrum Disorder

“…Elevation of prolactin concentration corresponds to dopamine D2 receptor blockade [9,10]. Most studies report that children and adolescents treated with risperidone have 38-50% incidence of hyperprolactinaemia [4,[11][12][13][14][15][16].Early studies reported adverse effects associated with prolactin elevation because hyperprolactinaemia is one of the most common endocrinological disorders of the hypothalamic-pituitary axis [8]. Hyperprolactinaemia in female patients can result in amenorrhoea, galactorrhoea, anovulation and irregular menses, and in male patients, it can lead to azoospermia, impotence, gynaecomastia and galactorrhoea [17].…”

“…Moreover, risperidone has been demonstrated to have moderate and clinically significant benefits [3] in treatment of behavioural disturbances, including attention deficit hyperactivity disorder, anxiety disorders and obsessive-compulsive disorder [4].…”

“…Elevation of prolactin concentration corresponds to dopamine D2 receptor blockade [9,10]. Most studies report that children and adolescents treated with risperidone have 38-50% incidence of hyperprolactinaemia [4,[11][12][13][14][15][16].…”