FDA panel cautiously OKs antipsychotic drugs for kids

ADELPHI, Maryland Wed Jun 10, 2009 9:06pm EDT

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ADELPHI, Maryland (Reuters) - Three widely used antipsychotic medications appear safe and effective overall in treating children and teenagers with schizophrenia or bipolar disorder, a U.S. advisory panel said on Wednesday.

The Food and Drug Administration's panel of outside experts backed wider use of the pills -- Eli Lilly and Co's Zyprexa, AstraZeneca's Seroquel and Pfizer's Geodon -- but expressed concern over long-term effects the medications may have in younger patients.

The drugs are already approved for adults and are given to youngsters at a doctor's discretion, reaching $10 billion in combined annual sales. FDA approval would allow the drugmakers to market them specifically for children and teenagers.

Panelists overall said the companies' data showed the drugs, known as atypical antipsychotics, are effective and reasonably safe for children as young as 10 years old. But some members said the short-term studies do not show how youngsters would fare when treated over time for the chronic conditions.

"I'm concerned about the lack of true long-term studies" especially in younger patients "who will have a long lifetime, hopefully," said Ruth Day, a researcher at Duke University.

The FDA will weigh the panel's recommendations before later making its final approval decisions for the three drugs. Agency officials, speaking to reporters after the two-day meeting, declined to say when they would rule.

The companies told panelists on Tuesday that the benefits of treating symptoms of schizophrenia, which causes hallucinations and delusions, and bipolar disorder, which causes dramatic mood swings from manic episodes to depression outweighed the drugs' risks.

But on Wednesday, a number of FDA's advisers questioned why the FDA seemed willing to accept the drugs for what could be years of use when some studies only looked at children and teenagers for as little as three or six weeks.

They also said they were troubled not only about the potential increased use among even younger patients, but also the chance the drugs may be misused to treat other conditions such as attention deficit disorder or hyperactivity.

Panelist Kenneth Towbin said he worried that "soon we'll be seeing 4-, 5- and 6-year-olds being treated."

"It's a slippery slope ... I just get worried about where this is going," said Towbin, head of the National Institute of Mental Health's child psychiatry mood disorders program.

AstraZeneca and Lilly are seeking to sell their drugs for both schizophrenia and bipolar mania, while Pfizer's is seeking approval only for bipolar disorder. The companies, in separate statements, welcomed the panel's recommendations.

Zyprexa is Lilly's top-selling drug with sales of $4.7 billion last year. Seroquel is the second-best-selling product for AstraZeneca with 2008 sales of $4.5 billion. Sales of Pfizer's Geodon topped $1 billion in 2008.

Two similar drugs are already approved for youngsters -- Johnson & Johnson's Risperdal and Bristol-Myers Squibb Co's Abilify.

Studies showed Zyprexa, Seroquel and Geodon generally have the same side effects in youth as in adults such as weight gain and sleepiness, the FDA said. Panelist agreed and noted the need for additional treatment options. But they said the question was whether over time there could be an impact on brain development and other reactions not seen in adults.

"Children and adolescents are not just little adults," said Tana Grady-Weliky, a psychiatrist at Oregon Health and Science University.

(Reporting by Susan Heavey, editing by Leslie Gevirtz and Carol Bishopric)

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