Voluntary withdrawal of Xigris

[spacecowgirl]

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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.




http://www.fda.gov/Safety/MedWatch/...tyAlertsforHumanMedicalProducts/ucm277143.htm

 

[All4MyDaughter]

This sounds like a good journal club topic!!

 

[delano2000]

This sounds like a good journal club topic!!

👍


Saw that this morning.

 

[xiphoid2010]

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.




http://www.fda.gov/Safety/MedWatch/...tyAlertsforHumanMedicalProducts/ucm277143.htm

Woot! Time to go read that one.

 

[Trent Steele]

Looks like their explanation is that the model of care for sepsis has changed a lot over ten years, and ten years ago xigris was legit; not so much anymore.

 

[awval999]

In a recently completed clinical trial (PROWESS-SHOCK trial), Xigris failed to show a survival benefit. In this trial of 1696 patients, 851 patients were enrolled in the Xigris arm and 845 patients were enrolled in the placebo arm. Results based on preliminary analyses done by Eli Lilly and Company, that were submitted to the FDA, showed a 28-day all cause mortality rate of 26.4% (223/846) in Xigris-treated patients compared to 24.2% (202/834) in placebo-treated patients, for a relative risk of 1.09; 95% CI (0.92, 1.28), and P-value = 0.31 (not statistically significant).

 

[psychoandy]

Looks like their explanation is that the model of care for sepsis has changed a lot over ten years, and ten years ago xigris was legit; not so much anymore.

Early goal directed therapy, so hot right now!

 

[rph3664]

This was occasionally ordered at my previous hospital, and honestly, this drug scared me. On top of it, most of the time the patients didn't recover anyway.