FDA MedWatch Alert Warns About Risks of Eli Lilly's Xigris

Eli Lilly's Xigris may increase the risk of death in sepsis patients with single-organ dysfunction who recently underwent surgery, the FDA warned in a MedWatch alert.

The FDA alert, which came in conjunction with a "Dear Healthcare Professional" letter from Lilly, was prompted by exploratory analyses of two clinical trial databases. Researchers concluded that among sepsis patients with single-organ dysfunction and recent surgery, all-cause mortality was numerically higher in the Xigris group (drotrecogin alfa activated) compared to the placebo group.

Xigris, a biological therapeutic product, is intended to treat adult patients with severe sepsis who are at a high risk of death. Lilly noted in its letter that patients covered in the warning do not necessarily fall under Xigris' indication, and advised that patients only take the drug after careful consideration of its risks and benefits.

For more information, go to http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#Xigris (http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#Xigris).