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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 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 Communication - FDA]   Read more

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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 in patients with sepsis and baseline bleeding risk factors who received this product. Serious bleeding events occurred in 7 of 20 patients (35%) who had a bleeding risk factor vs. only 2 of 53 (3.8%) patients without any bleeding risk factors. The finding by Gentry et al. of an increased risk of death and serious bleeding events in patients treated with Xigris who also have baseline bleeding risk factors is consistent with the information in the current product label. Prescribers should refer ... Read more

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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 recent surgery, all-cause mortality was numerically higher in the Xigris group compared to the placebo group. Patients with single organ dysfunction and recent surgery may not be at high risk of death and therefore may not be among the indicated population. Xigris should be used in these patients only after careful consideration of the risks and benefits.[March 2005 - Letter - Eli Lilly] PDF Format[December 2004 - Revised Label - Eli Lilly] Read more

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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 Complete Organ Failure Resolution" over 14 days.A numerical increase in the rate of central nervous system (CNS) bleeding in the Xigris versus the placebo group was also noted. Over the infusion period the number of patients experiencing an intracranial hemorrhage event was 4 versus 1 for the overall population (Xigris vs. placebo), with 3 of the 4 events in the Xigris group occurring in patients aged 60 days or less. [April 21, 2005 - Read more

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