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

nited States for the treatment of schizophrenia, acute treatment of mixed and manic episodes of bipolar I disorder, and maintenance treatment of bipolar I disorder.

Zyprexa is indicated for the treatment of schizophrenia and manic or mixed episodes associated with bipolar I disorder in adolescents 13 to 17 years of age. When deciding among alternative treatments available for adolescents, clinicians should consider the increased potential for weight gain and hyperlipidemia compared to adults. Clinicians should consider the potential long-term risks when prescribing to adolescents, and in many cases this may lead clinicians to consider prescribing other drugs first in adolescents.

Olanzapine 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 death.

In addition, compared to elderly patients with dementia-related psychosis taking a placebo, there was a significantly higher incidence of cerebrovascular adverse events (e.g. stroke, transient ischemic attack) in elderly patients with dementia-related psychosis treated with olanzapine.

The possibility of a suicide attempt is inherent in schizophrenia and bipolar I disorder. Close supervision of high-risk patient should accompany drug therapy.

As with all antipsychotic medications, a rare and potentially fatal condition known as Neuroleptic Malignant Syndrome (NMS) has been reported with olanzapine. If signs and symptoms appear, immediate discontinuation is recommended. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmia). Additional signs may include elevated creatinine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.

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SOURCE Eli Lilly and Company
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