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Xigris to be Recalled Worldwide

Oct 26, 2011 | Parker Waichman LLP

Xigris patients in a clinical trial did not experience any added survival benefit compared to those treated with placebo, prompting Eli Lilly to issue a worldwide recall of the drug.  Xigris was approved a decade ago to treat sepsis and septic shock in patients admitted to hospital intensive care units.

The clinical trial that prompted the Xigris recall was called the PROWESS-SHOCK trial.

The study began in 2008, and involved 1696 patients. Roughly half  were treated with Xigris. Results based on preliminary analyses done by Eli Lilly that were submitted to the U.S. Food & Drug Administration (FDA) showed a 28-day all cause mortality rate of 26.4% (223/846) in Xigris-treated patients compared to 24.2%  in placebo-treated patients.

While earlier Xigris studies had linked it with a risk of serious bleeding, no significant higher risk was found in the PROWESS-SHOCK trial. 

According to the FDA, all remaining Xigris product should be returned to the supplier from whom it was purchased.  Xigris treatment should not be started in any new patients, while patients currently being treated with the drug should have the treatment terminated.

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