FDA Is Urged to Approve Three Antipsychotic Drugs for Adolescent Use

By Shankar Vedantam
Washington Post Staff Writer
Thursday, June 11, 2009

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.

The antipsychotic drug market in the United States is worth $14.6 billion, according to the Associated Press.

Should the FDA grant approval for the drugs, that figure is likely to grow. If the three drugs are approved, they would join the antipsychotic drugs Risperdal and Abilify, which already have FDA approvals for use among children.

Several scientific groups, including the American Psychiatric Association and the American Academy of Child and Adolescent Psychiatry, have urged regulators to allow physicians treating children with serious disorders the flexibility to choose from a range of drugs.

More than two-thirds of adults with bipolar disorder, the scientific advocacy groups added, appear to have experienced symptoms since childhood, which the groups said underscored the importance of treating such disorders early.

Bipolar disorder is a psychiatric ailment marked by sudden mood swings between mania and depression; schizophrenia is characterized by disordered thinking, hallucinations and delusions, and marked reductions in social skills.

Critics of the drugs have said that far too many American children are on such medications, and they point to recent revelations -- often unearthed by lawyers in the context of lawsuits against pharmaceutical companies -- that suggest drugmakers have not been open with physicians and regulators about the risks and benefits of their products. Although such medications were hailed as wonder drugs when they were introduced several years ago, federally funded studies and other recent analyses have highlighted that they can have questionable long-term effectiveness, as well as serious metabolic side effects, including weight gain and an increased risk for diabetes.

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