March 18, 2005

FDA ALERT

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Eli Lilly and FDA notified healthcare professionals about revisions to the WARNINGS section of labeling for Xigris [drotrecogin alfa (activated)], a biological therapeutic product indicated for the treatment of adult patients with severe sepsis who are at high risk of death. This warning is based upon analyses of two clinical trial databases. Among patients with single organ dysfunction and recent surgery, all-cause mortality was numerically higher in the Xigris group compared to the placebo group. Patients with single organ dysfunction and recent surgery may not be at high risk of death and therefore may not be among the indicated population. Xigris should be used in these patients only after careful consideration of the risks and benefits.

Read the complete MedWatch 2005 Safety Summary, with links to the Dear Healthcare Professional letter and revised label, at:
http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#Xigris