Three antipsychotic drugs that have long been prescribed to adolescents even though they were not approved for such use by the Food and Drug Administration deserve to have the regulatory agency's imprimatur, an FDA advisory committee said yesterday.
After weighing the costs and benefits of prescribing the antipsychotic drugs Seroquel, Geodon and Zyprexa for children 10 to 17 years old who suffer from schizophrenia and manic depression, the medical experts recommended that the drugs be approved for such use.
The regulatory agency is not required to follow the recommendations by the medical panel but usually does. In a briefing document, Thomas Laughren, the FDA's director of the division of psychiatry products, indicated that the agency's evaluation of clinical trials conducted by AstraZeneca, Pfizer and Eli Lilly, had shown the medications were effective in children. The risk profile of the drugs among children, Laughren added, was similar to the side effects they caused among adults, for whom the drugs are already approved.
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