Lilly Warns of Zyprexa Risks Among Elderly

Use of Schizophrenia Drug May Increase Risk of Death and Stroke Among Elderly

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Feb. 20, 2004 -- Drug manufacturer Eli Lilly and Co. is warning doctors that its drug Zyprexa may increase the risk of death and stroke when used by elderly patients with dementia.

Zyprexa is currently approved by the FDA for use in treating schizophrenia and some forms of bipolar disorder. It has not been approved for treating dementia-related mental problems among the elderly.

But some doctors have reported using the drug to treat dementia-related mental problems, such as anxiety, delusions, and aggression. A Lilly spokesman says this "off-label" use of the drug may account for up to 2% of all Zyprexa use.

Janssen Pharmaceutica, Inc., maker of the schizophrenia drug Risperdal, issued a similar warning in April 2003 about the use of their drug and the increased risk of stroke among elderly people with dementia.

Schizophrenia Drugs May Increase Risks Among Elderly

The Zyprexa warning letter was sent to doctors last month and was based on a review of five placebo-controlled studies conducted by Lilly involving more than 1,600 elderly patients with various forms of dementia, including Alzheimer's disease.

The review showed that the risk of death was more than twice as high among those taking Zyprexa than in the placebo group (3.5% death rate vs. 1.5%, respectively). Deaths did not appear to be associated to the dose of the drug they were taking or the duration of use.

But researchers found factors associated with a higher risk of death among Zyprexa users included:

The studies also showed an increased risk of stroke among elderly patients with dementia using Zyprexa. Prescribing information for the drug was updated in January 2004 to include information on this risk.

Lilly officials say the effectiveness of Zyprexa in elderly people with dementia has not been established.

"This information reconfirms the need for careful patient assessment and consideration of risk in the treatment of elderly patients with dementia-related psychosis," they write.

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SOURCES: Eli Lilly and Company. FDA.
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