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FDA Medwatch Alert: Xigris [drotrecogin alfa (activated)]: Market Withdrawal - Failure to Show Survival Benefit
Posted 27 Oct 2011 by Drugs.com
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 ...
FDA Medwatch Alert: Xigris (Drotrecogin alfa (activated)) - Early Communication about an Ongoing Safety Review
Posted 4 Feb 2009 by Drugs.com
[Posted 02/04/2009] FDA is aware of a recently published study, a retrospective medical record review of 73 patients who receive Drotrecogin alfa (activated), marketed as Xigris, indicated for the reduction of mortality in adult patients with severe sepsis who have a high risk of death (Gentry et al.; Crit Care Med 2009).The study reported an increased risk of serious bleeding events and of death ...
FDA Medwatch Alert: Xigris [drotrecogin alfa (activated)] - Mar 17, 2005
Posted 17 Mar 2005 by Drugs.com
Eli Lilly and FDA notified healthcare professionals about revisions to the WARNINGS section of labeling for Xigris [drotrecogin alfa (activated)], a biological therapeutic product indicated for the treatment of adult patients with severe sepsis who are at high risk of death. This warning is based upon analyses of two clinical trial databases. Among patients with single organ dysfunction and ...
FDA Medwatch Alert: Xigris [drotrecogin alfa (activated)] - Apr 28, 2005
Posted 28 Apr 2005 by Drugs.com
Eli Lilly and FDA notified healthcare professionals of the stopping of enrollment in a randomized, double-blind, placebo-controlled trial of Xigris in pediatric patients with severe sepsis. Xigris is not indicated for use in pediatric severe sepsis. A planned interim analysis showed that Xigris was highly unlikely to show an improvement over placebo in the primary endpoint of "Composite Time to ...