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FDA Approves Lilly's Zyprexa for Two Adolescent Indications
Date:12/4/2009

e may remit, partially or completely, if antipsychotic treatment is withdrawn.

Olanzapine may induce orthostatic hypotension associated with dizziness, tachycardia, bradycardia, and in some patients, syncope, especially during the initial dose-titration period. Particular caution should be used in patients with known cardiovascular disease, cerebrovascular diseases, or those predisposed to hypotension.

Other potentially serious adverse events include decreased white blood cell count (leukopenia, neutropenia, agranulocytosis), seizures, elevated prolactin levels, cognitive and motor impairment, body temperature elevation, and trouble swallowing.

The recommended starting dose for adolescents is lower than that for adults. Compared to patients from adult clinical trials, adolescents were likely to gain more weight, experience increased sedation, and have greater increases in total cholesterol, triglycerides, LDL cholesterol, prolactin and hepatic transaminase levels. When deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential for weight gain and hyperlipidemia compared to adults. Clinicians should consider the long-term risks when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents. Medication treatment for adolescent schizophrenia and bipolar I disorder should be initiated only after a thorough diagnostic evaluation and careful consideration of the risks associated with medication treatment. Medication treatment for both adolescent schizophrenia and bipolar I disorder is indicated as part of a total treatment program that often includes psychological, educational and social interventions. Safety and effectiveness of olanzapine in patients <13 years of age have not been established.

The most common treatment-emergent adverse event associated with oral Zyprexa in placebo-controlled, short-te
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SOURCE Eli Lilly and Company
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