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Friday September 3, 2010

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FDA Advisory Panel Recommends Seroquel, Zyprexa, Geodon for Use in Kids

A panel of medical experts who advise the Food and Drug Administration on the safety and effectiveness of drugs has just announced that Seroquel, Zyprexa, and Geodon, three potent antipsychotics already used in adults, should also be approved for use in teens and younger children.

The makers of Seroquel, Zyprexa, and Geodon had asked for permission to market the drugs for treatment of schizophrenia or bipolar disorder in kids. The advisory FDA panel found that Seroquel is a useful treatment for adolescents between the ages of 13 and 17. It also recommended allowing the marketing of Zyprexa and Geodon to teens as young as 10 years old.

Seroquel is made by AstraZeneca, Zyprexa is from Eli Lilly and Co., and Geodon is marketed by Pfizer.

While the FDA is not required to follow the advice of its advisory panels, it most often does. A final ruling on the adolescent use of the drugs could be announced in the coming weeks.

Seroquel and other antipsychotics are big money makers for drug companies and are the top-selling class of prescription drugs in the United States. As many as 2.4 million Americans are diagnosed with schizophrenia, a disorder which causes delusional thoughts, hallucinations, and aggressive social interaction. Another 5.7 million Americans battle bipolar disorder, which results in wide and unpredictable mood swings.

However, Seroquel, Zyprexa, and Geodon have been associated with severe side effects and complications, including diabetes and weight gain.

The FDA panel, while recommending broader uses of the drugs, did express concerns about the long-term use of powerful antipsychotic drugs among younger patients, who being taking the drugs as children and continue taking them into adulthood. Short-terms studies of the drugs have not addressed the continued use of the drugs, officials cautioned.

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