The FDA is working with Eli Lilly to review the findingsof a recently published study showing an increased risk of serious bleedingevents and death in patients treated with Xigris (drotrecogin alfa [activated]). The study was aretrospective medical record review of 73 patients on Xigris. Serious bleedingevents occurred in 7 of 20 patients (35%) who had a bleeding risk factor versusonly 2 of 53 (3.8%) patients without any bleeding risk factors. More patientswith baseline bleeding risk factors died (13/20: 65%) compared to patientswithout any bleeding risk factors (13/53; 24.5%). These study findings of anincreased risk of death and serious bleeding events in Xigris-treated patientswho also have baseline bleeding risk factors is consistent with the informationin the current product label.

Xigris is indicated to reduce mortality in severe sepsis in patients with a high risk of death.

For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm092099.htm.