Eli Lilly is adding a new warning to the label of its sepsis treatment, Xigris (drotrecogin alfa), after the drug was linked to an increased mortality rate in clinical trials of patients with single organ dysfunction who had recently undergone surgery.

Lilly notes that an analysis of specific two clinical trials showed that “all-cause mortality was numerically higher” amongst patients treated with Xigris, versus those receiving placebo. Specifically, 10 out of 49 patients taking Xigris in the so-called Prowess trial died, and 14 were hospitalised, while eight out of 49 patients receiving placebo died, and eight were hospitalised. In the larger, Address trial, 67 out of 323 Xigris receivers died and 76 were hospitalised, versus 44 out of 313 deaths and 62 hospitalisations for the placebo group.

According to a letter posted on the US Food and Drug Administration’s website yesterday: “This new warning… applies only to patients with organ dysfunction and recent surgery. These patients may not be at high risk of death and therefore may not be indicated for Xigris.” Xigris is indicated for the treatment of adults with severe sepsis who are at high risk of death [[22/11/01b]], and Lilly says that the product should only be used in patients with single organ dysfunction and recent surgery “after careful consideration of the risks and benefits.”