Eli Lilly Sends Two Warning Letters—and Gets One Itself

Oct 10, 2007
By Pharmaceutical Executive Editors

Eli Lilly mailed out two Dear Doctor letters for the drugs Zyprexa (Olanzapine) and Symbyax (Fluoxetine) and received one warning letter regarding labeling and marketing issues for Cymbalta (Duloxetine).

Letters to professionals for Zyprexa and Symbyax included new labeling warnings for weight gain and hyperlipidemia, and updated information in the warning for hyperglycemia, according to a release from the company.

The company stated that the updates stem from new information gathered from Lilly's clinical trial data in adults and adolescents, as well as information from two non-Lilly studies of atypical antipsychotics and discussions with FDA.

"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," said Sara Corya, global medical director for Lilly. "This information will continue to help healthcare professionals evaluate and make the best treatment decisions for individual patients."

Additionally, FDA sent a warning letter to Lilly, posted October 2, stating that a mailer for Cymbalta's professional advertising campaign was false or misleading and that it "overstated the efficacy of Cymbalta and omits some of the most serious and important risk information associated with its use."

According to Les Funtleyder, a drug analyst at Miller Tabak and Co., "I don't think there's anything in the warning letters that people didn't already know. The stock didn't react, so the suggestion is that the letters weren't that material."

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