February 04, 2009
FDA reviews Xigris safetyThe FDA is working with Eli Lilly to review the findings of a recently published study showing an increased risk of serious bleeding events and death in patients treated with Xigris (drotrecogin alfa [activated]). The study was a retrospective medical record review of 73 patients on Xigris. Serious bleeding events occurred in 7 of 20 patients (35%) who had a bleeding risk factor versus only 2 of 53 (3.8%) patients without any bleeding risk factors. More patients with baseline bleeding risk factors died (13/20: 65%) compared to patients without any bleeding risk factors (13/53; 24.5%). These study findings of an increased risk of death and serious bleeding events in Xigris-treated patients who also have baseline bleeding risk factors is consistent with the information in 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.