On October 25, 2011, Eli Lilly announced a voluntary-recall of activated drotrecoginalfa (Xigris) following a recent trial (PROWESS-SHOCK), which demonstrated no survival benefit when using the drug when compared to placebo.
Activated drotrecoginalfa 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 drotrecoginalfa 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 drotrecoginalfa 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.
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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