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Patent Pending rhAPC has been the subject of significant controversy since its approval for clinical use in 2001. A 2011 Cochrane review concluded that it does not decrease mortality in severe sepsis or septic shock.[8] It has been noted that rates of severe hemorrhages, drug infusion-related fatal events and termination of infusion due to adverse reactions are all higher in clinical use and open-label trials than in controlled trials. There is a dispute as to whether or not studies after PROWESS confirm its results, and if so, for what subgroups.
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