The FDA has approved (Giapreza) (La Jolla), an IV formulation of synthetic angiotensin II, to increase blood pressure in adults with septic or other vasodilatory shock, such as anaphylactic or neurogenic shock. Angiotensin is a naturally occurring peptide hormone in the renin-angiotensin-aldosterone system (RAAS). (Giapreza) is the first synthetic angiotensin II product to become available in the US.

The FDA has announced that Eli Lilly has voluntarily withdrawn drotrecogin alfa (activated) (Xigris) after a recently completed trial (PROWESS-SHOCK) in patients with severe sepsis and septic shock failed to show an increase in survival in those treated with the drug.1 Drotrecogin alfa is a recombinant form of human activated protein C. Native activated protein C inhibits coagulation, increases fibrinolysis and has anti-inflammatory properties. FDA approval of Xigris (for patients with severe sepsis at high risk of death) was based on a single study (PROWESS).2 Post-marketing studies found a higher rate of bleeding than that reported in PROWESS.3,4

1. FDA Drug Safety Communication: voluntary market withdrawal of Xigris [drotrecogin alfa (activated)] due to failure to show a survival benefit. Available at http://www.fda.gov/Drugs/DrugSafety/ucm277114. htm. Accessed December 1, 2011.

2. Activated protein C (Xigris) for severe sepsis. Med Lett Drugs Ther 2002; 44:17.

3. E Abraham et al. Drotrecogin alfa (activated) for adults with severe sepsis and a low risk of death. N Engl J Med 2005; 353:1332.

4. KM Rowan et al. Drotrecogin alfa (activated): real-life use and outcomes for the UK. Crit Care 2008; 12:R58.

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Drotrecogin alfa (activated) (Xigris - Lilly), recombinant human activated protein C, has been approved by the FDA for treatment, in combination with standard therapy, of critically ill adults with severe sepsis and a high risk of death.