Eli Lilly and Company announced withdrawal of its Xigris® [drotrecogin alfa (activated)] product in all markets following results of the PROWESS-SHOCK study, which showed the study did not meet the primary endpoint of a statistically significant reduction in 28-day, all-cause mortality in patients with septic shock. The company is working with regulatory agencies on this withdrawal, and is in the process of notifying healthcare professionals and clinical trial investigators.
Physicians should not initiate treatment with Xigris in new patients and should stop ongoing treatment. The Society of Critical Care Medicine will keep the critical care community updated on this issue as appropriate.
More information for clinicians about the withdrawal of activated drotrecogin alfa is available on the European Medicines Agency and the U.S. Food and Drug Administration websites.
Adult
Update regarding rhAPC Recommendation in Surviving Sepsis Campaign Guidelines*
In response to the removal of Xigris® [drotrecogin alfa (activated)], also referred to as rhAPC, in all markets following results of the PROWESS-SHOCK study, the Surviving Sepsis Campaign withdraws its suggestions for use of rhAPC as stated in “Surviving Sepsis Campaign: International guidelines for management of severe sepsis and septic shock.” (1). The study did not meet the primary endpoint of a statistically significant reduction in 28-day, all-cause mortality in patients with septic shock.
Eli Lilly and Company, the maker of Xigris ®, is working with regulatory agencies on this withdrawal, and is in the process of notifying healthcare professionals and clinical trial investigators. According to their news release, physicians should not initiate treatment with Xigris in new patients and should stop ongoing treatment.
1. Dellinger RP, Levy MM, Carlet JM, et al. Surviving Sepsis Campaign: International guidelines for management of severe sepsis and septic shock. Crit Care Med 2008; [published correction appears in Crit Care Med 2008; 36:1394-1396] 36:296-327
*This revised recommendation was approved by the Surviving Sepsis Campaign Executive Committee and posted on the SSC website and list-serve on October 27, 2011.
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