Europe. The EMEA's Committee for Medicinal Products for Human Use (CHMP) has recommended drotrecogin alfa (Xigris) be used only in high-risk patients (that is patients at a high risk of death from sepsis associated with acute organ dysfunction) and when therapy can be started within 24 hours of organ failure. Additionally, the committee has recommended that drotrecogin alfa (Xigris) be used only by experienced doctors in institutions skilled in the care of patients with severe sepsis, and that the agent should not be used in patients with single organ dysfunction, especially if they have had recent surgery. It may be recalled that some months ago Eli Lilly had issued letters to health professionals in Canada and in the US warning about a higher mortality in patients treated with drotrecogin alfa compared to placebo (see WHO Pharmaceuticals newsletter No., 2005).
EMEA's post-authorisation summary of opinion for Xigris, EMEA/138447/2005, 21 April 2005 (http://www.emea.eu.int).