FDA advisory committee to vote on antipsychotic drugs for kids

Eli Lilly, Pfizer, AstraZeneca

On Wednesday, an advisory committee of the Food and Drug Administration will vote on whether three best-seller psychiatric drugs, presently approved for treatment of schizophrenia and bipolar disorder in adults, should be used for treating similar disorders in adolescents as well.

Already commonly prescribed "off-label" to children and teens, these three drugs are Seroquel from AstraZeneca PLC; Geodon from Pfizer; and Zyprexa from Eli Lilly - which together achieved over $7.4 billion sales in 2008. Meanwhile, two other antipsychotic drugs - Risperdal and Abilify - are currently the approved drugs for treating bipolar disease and schizophrenia in patients below the age of 18 years.

In a memo to the FDA advisory committee members, Thomas Laughren - Director Psychiatry Products Division of FDA - said: "We generally are in agreement that the sponsors - the makers of Seroquel, Geodon and Zyprexa - have provided adequate support to suggest effectiveness" for treating schizophrenia and bipolar disorder conditions in children aged 10-17 years. 

Laughren also added that the safety of the three mentioned drugs was apparently akin in quality to the safety profiles observed with these drugs in adult patients. However, Laughren further said that these essentially "atypical" antipsychotics can cause some adverse reactions, which include weight gain, sedation, increases in blood fats and sugars and tardive dyskinesia or the involuntary repetitive movements' condition.

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