FDA Approves Antipsychotic Risperdal For Adolescents And Children

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Main Category: Pediatrics / Children's Health
Also Included In: Schizophrenia;  Bipolar;  Regulatory Affairs / Drug Approvals
Article Date: 23 Aug 2007 - 2:00 PDT

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The US Food and Drug Administration (FDA) has approved Johnson & Johnson's (J&J) atypical antipsychotic drug Risperdal (chemical name risperidone) for use in two types of treatment with children and adolescents. The approval was given yesterday, 22nd August.

One application is for short treatment of schizophrenia in adolescents aged from 13 to 17 and the other is for short term treatment of manic or mixed episodes of bipolar I disorder in children aged between 10 and 17.

Lithium has been the only FDA approved pediatric drug for treating schizophrenia and bipolar disorder in these age groups until now.

Risperdal first gained FDA approval in 1993 for treating adult schizophrenia and later for short term treatment of acute manic or mixed episodes of bipolar I disorder in adults. At the second approval it was also approved for treating irritability associated with autistic disorders in children from 5 to 16 years of age.

Director of FDA's Office of Pediatric Therapeutics, Dr Dianne Murphy said the studies on Risperdal showed that at the proper dose, the drug was safe and effective for use as indicated. The data from the studies have:

"Permitted the identification of the effective pediatric dose ranges and have provided an evidence-based approach for treating these disorders in pediatric patients," said Murphy.

The evidence for approving use to treat schizophrenia came from two short term double blind, controlled trials, lasting up to 8 weeks.

The participants were all having an acute schizophrenia episode when they enrolled in the trials.

After treatment with the drug, patients experienced fewer symptoms such as fewer delusional thoughts and hallucinations.

The evidence to support the use of Risperdal to treat children and adolescents with bipolar I disorder manic or mixed episodes came from a 3 week trial.

The evidence was gathered across a number of treatment centres where patients were enrolled in the randomized, double-blind, placebo-controlled trial.

All patients were having a a manic or mixed episode at the time of enrollment.

Results from this trial showed that patients generally experienced fewer symptoms after treatment with the drug. Reductions were seen in hyperactivity, elevated mood, and other symptoms.

The most common side effects included fatigue, increased appetite, feelings of nausea and drowsiness, increased anxiety, dizzy spells, dryness in the mouth, tremors and rash.

About 1 in 100 adults in the US have schizophrenia, a severe, chronic and disabling brain disorder that makes people hear voices and believe that others are plotting against them. The result is people with schizophrenia become frightened and withdrawn and this affects their ability to form secure and happy relationships with others and hold down jobs.

Bipolar disorder, also called manic depressive illness, is a serious condition that seriously affects a person's ability to function in everyday life. They experience severe shifts in mood and energy, much more extreme than the ups and downs that most people have. Bipolar disorder affects 2 out of every 100 adult Americans. Like schizophrenia it damages relationships, makes it difficult to hold down a job and do well at school.

When treated, most people with schizophrenia or bipolar disorder can be helped to lead full and active lives.

Click here for more information on schizophrenia (National Institute of Mental Health, US).

Click here for more information on bipolar disorder (National Institute of Mental Health, US).

Click here for FDA.

Written by: Catharine Paddock


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