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Lilly Pulls Sepsis Drug WorldWide

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div itemprop="articleBody" class="article">Washington, DCThe US Food and Drug Administration (FDA) has issued a communication informing 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)]. Eli Lilly took the decision based on results from a recently completed clinical trial in which Xigris failed to show a survival benefit in patients with severe sepsis and septic shock. Xigris is indicated for the reduction of mortality in adult patients with severe sepsis who have a high risk of death.

According to the FDA statement, "Xigris treatment should not be started in new patients. Xigris treatment should be stopped in patients being treated with Xigris."

The recently completed PROWESS-SHOCK trial enrolled 1696 patients, 851 patients in the Xigris arm and 845 patients in the placebo arm. Results based on preliminary analyses done by Eli Lilly, that were submitted to the FDA, showed no statistically significant difference between the two arms.


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Posted by

I've had a totally different experience with Xigris. After being misdiagnosed in June 2002 I developed a servere case of bilateral pneumonia and servere sepsis and subsequently went into respiratory failure. The attending physicians notified my family and my prognosis was poor, they had never seen anyone that sick survive. However, after careful consideration I was given Xigris and the Doctors were amazed at both the fact that I recovered but also at how quick my recovery was.

Posted by

Now when will the stop Cymbalta? The drug from HELL!!!!


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