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Sepsis

FDA Split On Approval Of Eli Lilly's Xigris

Published in Medical Letter on the CDC and FDA, November 11th, 2001

Government scientists are split on whether a long-anticipated drug to treat deadly sepsis works well enough to sell.

Some advisers to the U.S. Food and Drug Administration said Eli Lilly's Xigris appeared to fight the bloodstream infections, while others argued that it's impossible to tell how well the drug worked because the sickest patients were excluded from study.

Sepsis strikes about 750,000 Americans a year, at least 225,000 of whom die when the infection leads to complications that destroy their organs. Many illnesses can lead to sepsis, including trauma, surgical complications and pneumonia.

Patients are treated with...

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