Blood Infection Drug Withdrawn From Market
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Xigris, which is a drug given to patients with severe sepsis and in danger of death, was withdrawn from the market today. The drug was approved by the FDA in 2001 in the United States, and it was approved in Europe in 2002. The drug is made by Eli Lilly & Co., who said it was being withdrawn because it failed to show a benefit in a recent clinical trial. The trial, the PROWESS-SHOCK trial, showed that the people taking Xigris actually had a higher mortality rate than those taking a placebo. The study began in 2008 at the request of a European regulatory advisory panel, who had concluded that the inital efficacy results seen in the approval studies of the drug hadn't been reproduced in further studies.
"Since the drug is no longer conferring an incremental benefit, it should be withdrawn from use.", said Timothy Garnett, Lilly's senior vice president and chief medical officer. The drug had come under watch from the FDA in 2009 when another clinical trial showed it increased bleeding and death in patients with sepsis. The global sales for the drug totaled $104 milion last year and were $74 million for the first nine months of 2011.
The FDA has issued a communication indicating that patients receiving the drug should have it discontinued, and no new patients should be started on the drug.