Drotrecogin alfa (Xigris) - Withdrawn From Worldwide Market
October 25, 2011
Eli Lily and Company announced a voluntary market withdrawal of drotrecogin alfa (Xigris). Drotrecogin alfa, or recombinant human activated protein C, was labeled for use in adults with severe sepsis to reduce mortality. However, drotrecogin alfa did not improve survival in the recently completed PROWESS-SHOCK trial in 1696 patients with severe sepsis or septic shock. The 28-day all-cause mortality rate was similar with drotrecogin alfa (26.4%) and placebo (24.2%). The relative risk for this endpoint was 1.09 (95% CI 0.92 – 1.28, p=NS).
Do not initiate drotrecogin alfa in new patients. Discontinue drotrecogin alfa in patients currently being treated with this product. Return any remaining product to the supplier. Additional information is available at the following links:
- MedWatch Alert:
- Drug Safety Communication:
October 25, 2011. University of Utah Drug Information Service. Copyright 2011, Drug Information Service, Universtiy of Utah, Salt Lake City, Utah.