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Optimer Pharmaceuticals, AŞ Message Board

  • mikeadd Nov 23, 2011 11:49 AM Flag

    More need for Vanco

    The withdrawal of the drug below from the market, IMO, will make the need for vanco that much greater in fighting systemic infections; hence, physicians should worry about drug resistance and hopefully use Fido first-line to avoid use of vanco for C diff.

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    • You are a complete idiot. The drug you are referring to "Xigris" is not an antibiotic. It is a immunomodulator used to halt the cascade of shock. Eli-Lilly withdrew thr drug because patient outcome was no better than no intervention at all. Vancomycin is an antibiotic, Xigris is not.... This board's IQ has gone to new lows.

    • Can't see the article, since it requires me to register. Do you have another link?

      • 1 Reply to wisemanrax
      • mikeadd Nov 23, 2011 12:28 PM Flag

        from Medscape Education Clinical Briefs > FDA Approvals and Safety Changes for CME

        FDA Safety Changes: Sepsis Drug Withdrawn From All Markets CME/CE

        News Author: Robert Lowes
        CME Author: Laurie Barclay, MD

        Authors and Disclosures

        CME/CE Released: 11/04/2011; Valid for credit through 11/04/2012

        Clinical Context

        Activated drotrecogin alfa is a recombinant form of human activated protein C. It was approved by the US Food and Drug Administration (FDA) nearly a decade ago to lower mortality rates in adults with severe sepsis and high mortality risk.

        However, the efficacy of activated drotrecogin alfa has always been controversial. The original vote by the FDA advisory panel that recommended approval was 20 to 20. As of 2007, trials had failed to replicate favorable results from the pivotal Recombinant Human Activated Protein C Worldwide Evaluation in Severe Sepsis (PROWESS) study.

        Study Synopsis and Perspective

        Eli Lilly is withdrawing activated drotrecogin alfa (Xigris), a drug intended to treat severe sepsis in high-risk patients, from all markets including the United States in the wake of a new study showing that the agent did no better than a placebo in reducing mortality risk.