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FDA Panel Mulls Newer Antipsychotics for Kids
Date:6/10/2009

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.

More information

For more information on atypical antipsychotics, visit the U.S. Food and Drug Administration .



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 Univer
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