TA84 Sepsis (severe) - drotrecogin: Guidance

Since the NICE guidance on drotrecogin alpha (activated) was issued, the European Medicines Evaluation Agency has recommended changes to the way that drotrecogin alpha (activated) should be used. These changes can be found on the EMEA website at http://www.emea.eu.int/htms/hotpress/h13844405.htm

In summary, the EMEA consider that drotrecogin alfa (activated) should only be used in high-risk patients, mainly in situations when therapy can be started within 24 hours of the onset of organ failure. In addition, it should only be used by experienced doctors in institutions skilled in the care of patients with severe sepsis. Drotrecogin alfa (activated) should not be used in patients with single organ dysfunction, especially if they have had recent surgery (within 30 days).

NICE advises that clinicians wishing to prescribe drotrecogin alpha (activated) should take the EMEA advice into account alongside the guidance from NICE when deciding whether or not to prescribe drotrecogin alpha (activated).