The U.S. Food and Drug Administration
today approved Risperdal (risperidone) for the treatment of
schizophrenia in adolescents, ages 13 to 17, and for the short-term
treatment of manic or mixed episodes of bipolar I disorder in
children and adolescents ages 10 to 17. This is the first FDA
approval of an atypical antipsychotic drug to treat either disorder
in these age groups.
Until now, there has been no FDA-approved drug for the treatment
of schizophrenia for pediatric use and only lithium is approved for
the treatment of bipolar disorder in adolescents ages 12 and up.
"The pediatric studies of Risperdal provided an opportunity to
assess the effectiveness, proper dose, and safety of using this
product in the pediatric population," said Dianne Murphy, M.D.,
director of FDA's Office of Pediatric Therapeutics. "These data have
permitted the identification of the effective pediatric dose ranges
and have provided an evidence-based approach for treating these
disorders in pediatric patients."
The FDA first approved Risperdal in 1993 for the treatment of
schizophrenia in adults. The drug later was approved for the
short-term treatment of acute manic or mixed episodes associated
with bipolar I disorder in adults and the treatment of irritability
associated with autistic disorder in children and adolescents 5 to
16 years old.
Evidence to support this approval was collected through studies
the FDA requested as part of its pediatric drug development
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
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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
from U.S. Food and Drug Administration