FDA is aware of a retrospective study (Gentry et al.: Adverse outcomes associated with the use of drotrecogin alfa (activated) in patients with severe sepsis and baseline bleeding precaution, Crit Care Med 2009),1 which reported an increased risk of serious bleeding events and of death in patients with sepsis (a severe illness related to a bloodstream infection) and baseline bleeding risk factors who received drotrecogin alfa (activated). Drotrecogin alfa (activated), marketed as Xigris, is a recombinant human activated protein C indicated for the reduction of mortality in adult patients with severe sepsis who have a high risk of death.3 The baseline bleeding risk factors as defined by this study are the same as those described in the Xigris prescribing information, under the Contraindications and the Warnings and Precautions sections of the package insert.
