FDA panel approves drugs for children

Psychiatric use deemed effective

By Matthew Perrone
Associated Press / June 11, 2009
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ADELPHI, Md. - Advisers to the Food and Drug Administration said yesterday that three blockbuster psychiatric drugs appear safe and effective for children and adolescents, despite side effects that can increase the risk of diabetes.

The FDA's panel of psychiatric experts voted to approve the use of drugs from AstraZeneca, Eli Lilly, and Pfizer for treating schizophrenia and bipolar disorder in patients ages 10 to 17.

The FDA is not required to accept the group's advice, though it usually does.

"We'll take all of this into consideration, but I can't make any promises about when we'll take action," said Dr. Thomas Laughren, FDA's director of psychiatric drugs.

All three drugs already are approved for adults with schizophrenia and bipolar disorder.

Their side effects include weight gain, high blood sugar, and sleepiness.

A positive FDA decision will expand the use of drugs that already make up the top-selling class of prescriptions in the United States, with 2008 sales of $14.6 billion, according to healthcare analysis firm IMS Health.

The panel - mainly comprised of psychiatrists - largely brushed aside concerns from patient and consumer advocates that the companies should have been required to conduct longer studies of the drugs' side effects.

The panel voted 11-4, with four abstentions, that Lilly's drug Zyprexa is safe for treating bipolar, despite evidence the drug causes significantly more weight gain than other treatments.

The Indianapolis-based company is only seeking approval for the drug as a second-choice, after other drugs have been tried.

"I had concerns about the metabolic side effects but if this is going to be used as the last treatment option then I think having other treatments available to physicians is worthwhile," said Dr. Frank Greenway, of Pennington Biomedical Research Center in Baton Rouge, La.

Schizophrenia affects about 2.4 million Americans and is characterized by hallucinations, delusions, and social withdrawal, according to the National Institute of Mental Health.

About 5.7 million Americans experience bipolar disorder, which causes rapid mood swings and shifts in energy.