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FDA Panel OKs AstraZeneca Psych Drug for Kids
Advisers to the FDA say a psychiatric drug from AstraZeneca is safe and effective for children and adolescents, despite side effects.
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Posted Wednesday, June 10, 2009 --- 3:20 p.m.
ADELPHI, Md. (AP) -- Advisers to the Food and Drug Administration say a psychiatric drug from AstraZeneca is safe and effective for children and adolescents, despite side effects that can increase the risk of diabetes.
The FDA's panel of experts has voted overwhelmingly that Seroquel is a useful treatment for schizophrenia and bipolar disorder in patients ages 13 to 17.
The group also voted 8-1 that Pfizer's Geodon is safe for children and adolescents with bipolar disorder, though nine panelists abstained, complaining of incomplete data from the company.
The group also is weighing expanded approval of Eli Lilly's Zyprexa.
All three drugs already are approved for adults with schizophrenia and bipolar disorder.
The FDA is not required to follow the group's advice, though it usually does.
Copyright 2009 by The Associated Press. All Rights Reserved.
