Evidence to support this approval was collected through studies the FDA requested as part of its pediatric drug development initiatives.
The efficacy of Risperdal in the treatment of schizophrenia in adolescents was demonstrated in two short-term (6 to 8 weeks), double-blind, controlled trials. All patients were experiencing an acute episode of schizophrenia at the time of enrollment. Treated patients generally had fewer symptoms, including a decrease in hallucinations, delusional thinking, and other symptoms of their illness.
The efficacy of Risperdal in the treatment of manic or mixed episodes in children or adolescents with bipolar I disorder was demonstrated in a three-week, randomized, double-blind, placebo-controlled, multicenter trial in patients who were experiencing a manic or mixed episode. Treated patients generally had fewer symptoms, including a decrease in their elevated mood and hyperactivity, and other symptoms of their illness.
Drowsiness, fatigue, increase in appetite, anxiety, nausea, dizziness, dry mouth, tremor, and rash were among the most common side effects reported.
Schizophrenia is a serious and disabling psychiatric disorder. Symptoms may include hallucinations, delusions, and disorganized thinking. Bipolar disorder, also known as manic-depressive illness, is a serious psychiatric disorder that causes wide shifts in a person's mood, energy, and ability to function.
Risperdal is manufactured by Janssen, L.P. of Titusville, N.J.
For more information:
FDA Office of Pediatric Therapeutics
National Institute of Mental Health—Schizophrenia
National Institute of Mental Health—Bipolar Disorder
Is this a good thing, or another attempt to put our youth under the influence of synthetic molecules? It seems to me, that any child that is different will likely now be prescribed Risperidone.