FDA Panel Mulls Newer Antipsychotics for Kids

June 10 (HealthDay News) -- A U.S. Food and Drug Administration advisory panel is expected to vote Wednesday on whether several powerful but controversial antipsychotic drugs be approved for use by children.

The drugs in question include new-generation "atypical" antipsychotics such as Geodon, Seroquel, and Zyprexa, currently approved for adult use. The medications are also being prescribed "off-label" by many doctors to treat schizophrenia and bipolar disorder in children ages 10 to 17, despite possible serious side effects, including diabetes and heart woes.

There is a pressing need for effective antipsychotics for children, one expert noted.

"Schizophrenia and bipolar disorder are very real illnesses, which collectively affect between 1 percent and 3 percent of all young people," noted Dr. David Fassler, a clinical professor of psychiatry at the University of Vermont College of Medicine, who testified before the panel Tuesday. "Without treatment, children have problems at school, at home, and with their friends. They're also at increased risk of accidents, hospitalization, and death at an early age from multiple causes, including suicide."

Fortunately, treatment is available to help children and adolescents who suffer from schizophrenia and bipolar disorder, including the medications being considered by the FDA panel, Fassler added.

Drug maker AstraZeneca is asking the FDA to let it market Seroquel to adolescents with schizophrenia and bipolar mania, also called manic depressive disorder. Pharmaceutical giant Lilly is asking for the same permission for its drug, Zyprexa. In addition, drug maker Pfizer wants approval to market a third atypical antipsychotic, Geodon, used to treat bipolar disorder, to patients 10 to 17.

And yet safety concerns plague many of these drugs. In 2004, the FDA ordered AstraZeneca to add a special "black box" warning to Seroquel's packaging, outlining increased risks of hyperglycemia, high blood pressure and diabetes associated with use of the drug. Also, older patients with dementia-related psychosis treated with Seroquel are at an increased risk of death, according to the FDA.

And in a unanimous vote in early April, an FDA advisory panel determined that Seroquel should not be approved as first-line therapy for adult depression, because of continued questions about its safety profile -- most notably, a link to higher risk for sudden cardiac death. However, the drug was approved for use in patients for whom other antidepressants didn't work.

The family of atypical antipsychotics has other well-documented potential side effects, including weight gain and high blood sugar, which can increase the risk of diabetes, as well as rapid heart beat, difficulty sleeping and trouble concentrating.

Prior studies have also found that these newer drugs are no more effective than older medications. Their main advantage is that they do not cause the tremors and muscle spasms associated with older agents.

Cost is an issue, as well: According to the Associated Press, these newer drugs are patent-protected and costs range between $300 to $500 per month, compared with about $100 per month for older antipsychotics.

There's also concern about the rapid increase in the use of these medications in pediatric populations in the absence of adequate research on long-term safety and efficacy, Fassler said.

"None of these medications should be used without careful considerations of the risks and benefits," Fassler said. "Children and adolescents taking these medications should be monitored closely for evidence of significant side effects or adverse reactions. Nonetheless, when used appropriately, these medications can be a helpful and effective component of treatment for children and adolescents with schizophrenia or bipolar disorder," he added.

Ronald T. Brown, dean and professor of public health at Temple University Health Sciences Center, also testified before the panel on Tuesday. He told the experts that there is still too little known about the efficacy and side effects of these medications in children to make them a standard of care.

"Serious questions have not been answered regarding the long-term effectiveness and, more importantly, safety of atypical antipsychotics in treating childhood disorders," Brown told the panel. "Continued, strong development of the research and knowledge base related to serious emotional disturbance and its treatment during childhood should be of the highest priority, and finally, physicians may continue prescribing Geodon, Seroquel, and Zyprexa off-label to children, as we continue to grow this knowledge base."

In any case, drugs should never be viewed as the only therapeutic option open to young patients, according to Fassler.

"Medication, including the atypical antipsychotics, can be helpful to control some of the signs and symptoms associated with these disorders, but medication alone is rarely an adequate or sufficient intervention. It should only be used as part of a comprehensive treatment plan, individualized to the needs of the child and family," Fassler said.

Although the FDA isn't required to follow advisory committee recommendations, it usually does.


SOURCES: David Fassler, M.D., clinical professor of psychiatry, University of Vermont College of Medicine, Burlington; Ronald T. Brown, Ph.D., dean and professor of public health, Temple University Health Sciences Center, Philadelphia; June 10, 2009, Associated Press

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