The Medical Letter on Drugs and Therapeutics
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1379
In Brief: Xigris Withdrawn
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 Select a term to see related articles  drotrecogin alfa   Drug Safety   Protein c   Septic shock   Xigris 

The FDA has announced that Eli Lilly has voluntarily withdrawn drotrecogin alfa (activated) (Xigris) after a recently completed trial (PROWESS-SHOCK) in patients with severe sepsis and septic shock failed to show an increase in survival in those treated with the drug.1 Drotrecogin alfa is a recombinant form of human activated protein C. Native activated protein C inhibits coagulation, increases fibrinolysis and has anti-inflammatory properties. FDA approval of Xigris (for patients with severe sepsis at high risk of death) was based on a single study (PROWESS).2 Post-marketing studies found a higher rate of bleeding than that reported in PROWESS.3,4

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