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APA Urges Caution in FDA Consideration of Psychotropic Drugs for Minors

APA expresses concern as the Food and Drug Administration considers approval of medications to treat bipolar disorder and schizophrenia in children.
In a statement presented on June 9 by Ronald Brown, PhD, the APA outlined to an FDA panel its concerns related to the agency's possible approval of three additional atypical antipsychotics to treat bipolar disorders and schizophrenia in children and adolescents.  PI-GRO coordinated the participation of Dr. Brown, who chaired APA's Working Group on Psychotropic Medications, and the Working Group's report provided the background for the statement.  Dr. Brown presented information on the need for more long-term effectiveness and safety data on the use of psychotropic medications in children, both generally and specifically with regard to the three drugs in question—Geodon, Seroquel, and Zyprexa.  The panel considering the applications, the Psychopharmacologic Drug Advisory Committee, ultimately voted to approve the three applications.  While the FDA is not obligated to follow this decision, it frequently follows the recommendations of its advisory committees.