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Eli Lilly: Zyprexa and Symbyax labels to show new warnings

Fri Oct 5, 2007 7:15am EDT

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Oct 5 (Reuters) - Eli Lilly and Co (LLY.N) said U.S. product labels for its schizophrenia and bipolar depression drugs Zyprexa and Symbyaxto will include new warnings for weight gain, cholesterol and elevated blood sugar, after talks with regulators.

Regulatory News

Cases of metabolic changes and weight gain have been reported as adverse events since Zyprexa's approval in the U.S. in 1996 and Symbyax's approval in 2003, the company said in a statement.

Labels for both drugs have also contained the U.S. Food and Drug Administration-mandated warning, which recommends monitoring patients for elevated blood sugar and diabetes, since 2003, it added. (Reporting by Aditi Samajpati in Bangalore)



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