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Eli Lilly updates Zyprexa and Symbyax labels
Eli Lilly has announced that, following its recently-completed analysis of clinical trial data and discussions with regulators, it has updated the product labels for Zyprexa (olanzapine) and Symbyax (olanzapine and fluoxetine Hcl).
The labelling for these pharmaceuticals has been revised in the US after dialogue with the US Food and Drug Administration (FDA), with the new information for the antipsychotic drugs including an updated warning for hyperglycemia and new warnings relating to weight gain and hyperlipidemia.
Zyprexa is a compound indicated as a treatment for schizophrenia, in addition to maintenance treatment of bipolar disorder and acute mixed and manic episodes of bipolar I disorder. Symbyax is indicated as a treatment for bipolar depression.
Sara Corya, global medical director at Lilly, said: “Zyprexa is an important treatment option for patients suffering from the devastating effects of schizophrenia and bipolar disorder, as is Symbyax for patients with bipolar depression.
“This information will continue to help healthcare professionals evaluate and make the best treatment decisions for individual patients.”
She added that the company recommends that doctors refer to expert guidelines treating patients with antipsychotics – irrespective of what medication is being administered.
In June 2007, Lilly reported the results of a survey claiming that product liability litigation relating to antipsychotics can adversely affect the treatment outcomes of patients with mental illness.
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