Antipsychotic drug Risperdal approved for use in children

Aug 23 2007

The Food and Drug Administration (FDA) in the U.S. has given approval for the antipsychotic drug Risperdal to be used to treat schizophrenia and bipolar disorder in children and teenagers.

The prescription drug is the first medicine cleared specifically to treat schizophrenia in children, but is already used to treat adults with schizophrenia and bipolar disorder and also for the irritability associated with autism in children ages 5 to 16.

Risperdal is produced by drug company Johnson & Johnson and the FDA approval will allow the company to promote the drug for schizophrenic patients ages 13 to 17, and for short-term treatment of bipolar episodes in ages 10 to 17.

The FDA approval comes with important information for doctors about dosing and side effects.

Risperdal was first approved in 1993 and is worth more than $4 billion to Johnson & Johnson each year but is expected to face stiff competition from cheaper generics next year.

Experts say schizophrenia usually manifests itself around age 18 for men and 25 for women.

It is a chronic, severe, and disabling brain disorder that has been recognized throughout recorded history and affects about 1 percent of Americans.

People with schizophrenia may hear voices other people don't hear or they may believe that others are reading their minds, controlling their thoughts, or plotting to harm them.

These experiences are terrifying and can cause anxiety, withdrawal, or extreme agitation.

People with schizophrenia may not make sense when they talk, may sit for hours without moving or talking much, or may seem perfectly fine until they talk about what they are really thinking.

Many people with schizophrenia have difficulty holding down a job or caring for themselves, placing a significant burden on their families and on society.

Although treatments can relieve many of the disorder's symptoms, there is no cure and and most people with schizophrenia will suffer from residual symptoms as long as they live.

The FDA says up to 1 percent of schizophrenia cases are seen in the younger age group for which Risperdal was approved.

Bipolar disorder which is also known as manic-depressive illness, causes wide swings in mood, energy and ability to function.

Studies by Johnson & Johnson found that a higher Risperdal dose was no more effective than a lower one in children and that information will be included on the drug's label.

According to the FDA patients taking Rispderal generally had fewer symptoms, including a decrease in hallucinations, delusional thinking, and other schizophrenia symptoms and bipolar patients generally had fewer symptoms of their disorder, including an easing of their elevated mood and hyperactivity.

Researchers found that side effects in the pediatric studies were similar to those experienced in adults and included drowsiness, fatigue, increase in appetite, anxiety, nausea, dizziness, dry mouth, tremor and rashes.

Dr. Thomas Laughren, director of the FDA's psychiatry drugs division says some studies have also suggested that weight gain could also be an issue as with many other anti-psychotic drugs used in adults.

Dr. Laughren says while both schizophrenia and bipolar disorders are serious conditions, doctors and families should weigh the risks and benefits of drug treatment.

Analysts say the use of antipsychotic drugs in patients up to age 19 jumped nearly 82 percent from 2001 to 2006.

Risperdal is known generically as risperidone and before the FDA granted approval only lithium was approved for treating bipolar disorder in adolescents age 12 years and up.