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Lilly Admits $1.4 Billion Zyprexa Mistake – Off Label Use

1/16/2009 11:00:00 PM  ,  

Was there not just something in the news this week about allowing off label use, well guess it doesn’t apply here.  The new ruling states the information provided has to be documented in medical journals in order to be distributed, but still it seems a bit gray.  At any rate, for elderly patients Lilly bit the dust on this one, no details on how it was promoted for off label use.  BD 

FDA lets drugmakers advise doctors on unapproved or off label use

Eli Lilly was the picture of remorse on Thursday, when the pharmaceutical company admitted to the improper marketing of its imageantipsychotic drug Zyprexa, agreeing to pay more than $1.4 billion in settlements.

The Indianapolis-based company admitted guilt in a misdemeanor violation of the Food, Drug and Cosmetic Act for its improper marketing of Zyprexa to elderly patients with dementia during the period of September 1999 to March 2001.

Zyprexa is approved by the U.S. Food and Drug Administration as a treatment for schizophrenia in patients over 18. Lilly admitted to promoting the drug to elderly patients for off-label use as a treatment for dementia. The drug caused increased risk of death in this patient group. Zyprexa was approved in 1996 and will lose patent protection in 2011. It had annual sales of $4.7 billion in 2007.

Lilly Admits $1.4 Billion Zyprexa Mistake - Forbes.com

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