Eli Lilly’s sepsis treatment, Xigris (drotrecogin alfa activated), has had its use restricted by the European authorities after data showing an increased mortality rate in clinical trials of patients with single organ dysfunction who had recently undergone surgery.

Back in March, the US Food and Drug Administration was quick to vocalize its warning that Xigris should be limited to patients who are at high-risk of death [[18/03/05b]]. At the time, Lilly also explained that the product should only be used in patients with single organ dysfunction and recent surgery “after careful consideration of the risks and benefits.”

However, Europe has gone one step further and deemed that Xigris only be used in high-risk patients with multiple organ failure and only if therapy can be initiated within 24 hours following onset of organ failure. In addition, the region’s advisory panel has recommended it only be used “by experienced doctors in institutions skilled in the care of patients with severe sepsis.”

The news will be a bitter pill to Lilly. Xigris was originally touted as one of the drugs that would help the US giant clamber out of the depression left by the earlier-than-expected loss of Prozac (fluoxetine) back in 2001, but suffered from the start with poor sales [[05/03/02a]], [[20/11/02f]].