On October 25, 2011, Eli Lilly announced a voluntary-recall of activated drotrecogin alfa (Xigris) following a recent trial (PROWESS-SHOCK), which demonstrated no survival benefit when using the drug when compared to placebo.
Activated drotrecogin alfa is a recombinant form of human activated protein C previously recommended for adults with severe sepsis and a high-risk of death (APACHE II > 25 or multi-organ failure); it is included in the 2008 International Sepsis Guidelines (Grade 2b recommendation).
The PROWESS-SHOCK trial reported an all-cause mortality rate of 26.4% in the drotrecogin alfa group compared with 24.2% in the placebo group; this difference was not statistically significant.
Interestingly, the study also found that severe bleeding (the drug's main side-effect) was found to be 1.2% in the activated drotrecogin alfa group compared to 1.0% for the placebo group (also non-significant) suggesting it does not increase the risk of bleeding as it had previously been reported.
Hospitals should revise their sepsis guidelines based on this recent news.
www.medscape.com/viewarticle/752169?sssdmh=dm1.728719&src=nl_newsalert
Dellinger, R. P., et al. Surviving Sepsis Campaign: International guidelines for management of severe sepsis and septic shock: 2008. Critical Care Medicine, 36(1), 296–327. doi:10.1097/01.CCM.0000298158.12101.41
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