HSA Updates On The Voluntary Worldwide Recall Of Xigris - 27 Oct 2011
Eli Lilly and Company has voluntarily recalled Xigris® [drotrecogin alfa (activated)] worldwide due to new clinical trial findings of lack of efficacy of the product.
2 Xigris® has been licensed locally since August 2002 for use in the reduction of mortality (number of deaths) in adult patients with severe sepsis* who have a high risk of death.
Background
3 The decision by Eli Lilly to withdraw Xigris® from the market was based on the recent 28-day mortality results from a clinical trial called the PROWESS-SHOCK**. In this clinical trial, Xigris® failed to show a survival benefit in patients with severe sepsis and septic shock. The study revealed an overall 28-day mortality of 26.4% in Xigris®-treated patients compared to 24.3% in the placebo control group. One possible reason for these findings could be that the standard of care for patients with sepsis and septic shock have advanced over the years.
HSA's Actions
4 Xigris® is available in both public and private healthcare institutions. The local recall of Xigris® is with immediate effect from today. Healthcare professionals have been informed of the recall and are advised to discontinue patients who are currently on Xigris® and not to initiate treatment in new patients.
*Severe sepsis is characterised by whole-body inflammation, presence of infection and organ dysfunction.
**The PROWESS-SHOCK is a placebo-controlled study and was conducted to determine if Xigris® treatment provides significant mortality reduction improvement in patients with septic shock compared with placebo treatment. This study also assessed the effectiveness of Xigris® in reducing 28-day mortality in patients with septic shock.
HEALTH SCIENCES AUTHORITY
27 OCTOBER 2011
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