February 23, 2004 INDIANAPOLIS (AP) -- Eli Lilly and Co. said it had warned doctors and psychiatrists that elderly patients suffering from dementia face a higher risk of stroke if they use the company's top-selling drug, the anti-psychotic Zyprexa.
Lilly made the warning in a letter sent nationwide on Jan. 15 based on findings from recent clinical trials of Zyprexa, Lilly spokesman Dan Collins said Friday. The U.S. Food and Drug Administration did not require the warning, he said.
"We felt it was important to be proactive in communicating this information about the increased risk of stroke in elderly patients with dementia-related psychoses," Collins said.
That category of patients accounts for about 2 percent of total Zyprexa sales, he said.
Clinical trials conducted to investigate whether to seek an FDA-approved indication for Zyprexa to treat that category of patients found those taking Zyprexa were more likely to suffer a stroke than those taking a placebo, Collins said. The Zyprexa patients also had a higher risk of death from all causes than those using a placebo.
Zyprexa is not approved for use in elderly patients with dementia, although some doctors do use the drug on a so-called "off-label" basis to help such patients get through episodes of dementia.
Because of the test findings, Lilly will not seek FDA approval for a Zyprexa indication to treat older patients with dementia, Collins said.
Introduced in 1996, Zyprexa now accounts for about a third of overall sales at Indianapolis-based Lilly, with Zyprexa sales last year reaching $4.3 billion Recently, the drug has come under competitive pressure because of the emergence of newer rivals Geodon and Abilify.
Zyprexa also is undergoing a patent challenge. Lilly and generic companies that want to introduce generic knockoffs of Zyprexa concluded a three-week bench trial in Indianapolis last week, and a federal judge is expected to issue a ruling in coming months. Industry analysts have said they expect Lilly to prevail.
On Friday, Lilly shares closed down 18 cents at $72.47 on the New York Stock Exchange.
Copyright 2004 The Associated Press. All rights reserved.
