Sepsis Drug Pulled

Xigris yanked from all markets after major study finds no survival benefit

/ Author:  / Reviewed by: Joseph V. Madia, MD

(RxWiki News) U.S. Food and Drug Administration officials announced that Eli Lily and Company have voluntarily pulled Xigris (drotrecogin alfa) from all markets because the medication failed to show increased survival for patients suffering from severe sepsis in a major study.

Xigris is prescribed to treat severe sepsis, a potentially deadly condition in which a serious infection is spread through the blood stream, and septic shock, characterized by decreased blood and oxygen flow, which can cause multiple organ failure or death.

"Call your doctor if you are currently taking Xigris."

FDA officials said the drug, offered as a treatment to lower the risk of mortality in patients with sepsis, should not be started in new patients, and that treatment with the medication should be stopped in patients already taking Xigris.

They request that remaining medication be returned to the supplier from which it was originally purchased. The drug is generally given to hospitalized intensive care patients.

During the recently completed PROWESS-SHOCK clinical trial, it was found that Xigris did not help patients survive longer. For the trial researchers enrolled 1,696 patients. Of those, 851 patients took Xigris and the remainder took a placebo.

Preliminary results submitted to the FDA indicated an all-cause mortality rate of 26 percent in patients who took the drug versus 24 percent in patients who took a placebo. The small difference was not considered statistically significant.

The study comes following a February statement by the FDA that the drug would undergo a safety review, prompted in part by a 2009 study published in journal Critical Care Medicine that found Xigris was linked to an increased risk of serious bleeding events or death in adult patients with serious sepsis. That study found that bleeding events occurred in 35 percent of patients who had a bleeding risk factor.

Health Canada also announced removal of the drug from the market today.

Reviewed by: 
Review Date: 
October 25, 2011
Last Updated:
October 25, 2011