View Entire Collection
By Clinical Topic
Diabetes – Summer 2012
Future of Nursing Initiative
Heart Failure - Fall 2011
Influenza - Winter 2011
Nursing Ethics - Fall 2011
Trauma - Fall 2010
Traumatic Brain Injury - Fall 2010
Fluids & Electrolytes
TUESDAY, Oct. 25 (HealthDay News) -- Xigris (drotrecogin alfa [activated]), used in the treatment of patients with severe sepsis, is being voluntarily pulled from the market by its manufacturer, Eli Lilly and Company, after failing to show a survival benefit in these patients, according to a drug safety notification issued Oct. 25 by the U.S. Food and Drug Administration.
To evaluate the mortality rate associated with the administration of Xigris, researchers enrolled 1,696 patients in a clinical trial in which 851 patients received Xigris and 845 received a placebo.
At 28 days, the researchers saw little difference between the two groups; the all-cause mortality rate in the treatment group was 26.4 percent, compared with 24.2 percent in the placebo arm.
According to the FDA, "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."
Sign up for our free enewsletters to stay up-to-date in your area of practice - or take a look at an archive of prior issues
Join our CESaver program to earn up to 100 contact hours for only $34.95
Explore a world of online resources
Back to Top