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FDA Advisory Committee Votes in Favor of Zyprexa for Two Adolescent Indications
Date:6/10/2009

unced in adolescents compared to adults, we agreed with the FDA that in many cases other available treatment options should be considered before Zyprexa when treating adolescents," said Dr. Hayes.

About Schizophrenia in Adolescents

Schizophrenia affects about 1 percent of Americans(4). A substantial portion of first psychotic breaks for schizophrenia occur in adolescence. It has been estimated that 39 percent of males and 23 percent of females with schizophrenia experience onset of the disease before the age of 19(5). Studies have suggested that early-onset schizophrenia is associated with worse long-term outcomes compared to onset of illness in adulthood(6).

About Bipolar Disorder in Adolescents

Bipolar disorder affects approximately 5.7 million American adults, or about 2.6 percent of the U.S. population age 18 and older in a given year(7). It has an estimated prevalence of 0.1 percent to 2 percent among adolescents(8). Lifetime prevalence of bipolar I disorder in community samples has varied from 0.4 percent to 1.6 percent(9). It has been estimated that 20 percent of all patients with bipolar disorder experience their first manic episode during adolescence, with the peak age of onset for this group of patients occurring between 15 and 19 years of age(10). Early onset of bipolar disorder is associated with greater severity of illness and more functional impairment(11).

Safety information for Oral Zyprexa (olanzapine)

Zyprexa is indicated in adults in the United States for the acute and maintenance treatment of schizophrenia, acute mixed and manic episodes of bipolar I disorder, and maintenance treatment of bipolar I disorder.

Zyprexa is not approved for the treatment of patients with dementia-related psychosis. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of deat
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SOURCE Eli Lilly and Company
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