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FDA, Eli Lilly Warn of Sepsis Drug Risk

Mar 17, 2005 | The Food and Drug Administration and Eli Lilly Co. (LLY) issued a warning Thursday about a treatment used in patients with severe sepsis, saying it might increase their risk of death, based on an analysis of two clinical trial databases.

The warning, however, only applies to patients who have had recent surgery and have a single organ dysfunction. The warning will be placed on the product label, which is sold under the brandname Xigris.

Sepsis is a potentially life-threatening condition that occurs when an infection spreads throughout the bloodstream. Xigris is used to treat adults with severe cases of sepsis who are at high risk of death.

The FDA said the clinical trial data showed that patients with single organ dysfunction and who have recently had surgery who took Xigris had higher rates of death than those in a placebo group.

The FDA and Lilly said "Xigris should be used in these patients only after careful consideration of the risks and benefits."

Lilly sent a letter, which the FDA released Thursday, to health-care professionals discussing Xigris and the clinical trial results.

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