Xigris [drotrecogin alfa (activated)]: Market Withdrawal - Failure to Show Survival Benefit

[Posted 10/25/2011]
AUDIENCE: Critical Care Medicine
ISSUE: FDA notified healthcare professionals and the public that on October 25, 2011, Eli Lilly and Company announced a worldwide voluntary market withdrawal of Xigris [drotrecogin alfa (activated)]. In a recently completed clinical trial (PROWESS-SHOCK trial), Xigris failed to show a survival benefit for patients with severe sepsis and septic shock.

BACKGROUND: Xigris is indicated for the reduction of mortality in adult patients with severe sepsis who have a high risk of death.

RECOMMENDATION: Xigris treatment should not be started in new patients. Xigris treatment should be stopped in patients being treated with Xigris. All remaining Xigris product should be returned to the supplier from whom it was purchased.

[10/25/2011 - Drug Safety Communication1 - FDA]

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Eli Lilly withdraws sepsis treatment Xigris

Drugmaker Eli Lilly and Co. is withdrawing the severe sepsis treatment Xigris from all markets because a recently concluded study showed that it is no longer effective. Severe sepsis is blood poisoning caused by an aggressive bacterial infection that can cause major organ failure. It can develop as a complication from pneumonia or bacterial infections. The Indianapolis company said Tuesday there is no safety issue with the drug, but a study started in 2008 found it failed to reduce mortality in patients with septic shock. Lilly said patients should stop taking Xigris, which U.S. regulators approved in 2001