FDA announced that" Xigris treatment should not be started in new patients. Xigris treatment should be stopped in patients being treated with Xigris.
All remaining Xigris product should be returned to the supplier from whom it was purchased''.
This announcment is based on PROWESS-SHOCK study, now complete, showed no benefit in its primary endpoint of 28 day mortality when compared with placebo in septic shock patients. There was also no benefit in a subgroup of patients with protein C deficiency, and no significant increased risk of severe bleeding.
By the way Xigris (drotrecogin alfa (activated)) is a recombinant form of human activated protein C
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