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News From the Food and Drug Administration
January 2, 2002

Drug for Severe Adult Sepsis

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JAMA. 2002;287(1):33. doi:10.1001/jama.287.1.33

The FDA has approved drotrecogin alfa (activated) (Xigris, Eli Lilly, Indianapolis), a recombinant form of human activated protein C, for the reduction of mortality in adults with severe sepsis (associated with acute organ dysfunction).

The effectiveness of the drug was shown in a multicenter, randomized, double-blind, placebo-controlled trial of 1690 adult patients with severe sepsis. Entry criteria included a systemic inflammatory response presumed due to infection and at least one of the following: cardiovascular, respiratory, or renal dysfunction; thrombocytopenia; or metabolic acidosis.