FDA reacts to worries about Lilly's Xigris

The US Food and Drug Administration says it is working with Eli Lilly to further evaluate the incidence of serious bleeding events and death in  patients who receive the firm's Xigris (drotrecogin alfa activated) for  the treatment of severe sepsis.

A retrospective study published in the journal Critical Care Medicine  found that serious bleeding events occurred in seven of 20 patients  (35%) who had a bleeding risk factor versus two of 53 (3.8%) subjects  who did not have any of the factors. Additionally, more people with  baseline bleeding risk factors died (13 of 20 patients, or 65%) compared  to those without (13 of 53, or 24.5%). However, the authors noted the  limitations of the study included the retrospective design and small  patient population.

Xigris' current labeling contra-indicates the use of the drug in several  clinical situations where bleeding could lead to significant adverse  reactions or death.