Drugs

FDA Drug Safety Podcast for Healthcare Professionals: Voluntary market withdrawal of Xigris [drotrecogin alfa (activated)] due to failure to show a survival benefit

Narrator: Welcome to the FDA Drug Safety Podcast for Healthcare Professionals from the Division of Drug Information. Today's topic: Voluntary market withdrawal of Xigris [drotrecogin alfa (activated)] due to failure to show a survival benefit.

Lindsay Davison, a pharmacist in the Division, will provide you with additional information about this Communication.

Guest speaker: On October 25, 2011 the Food and Drug Administration issued a Drug Safety Communication informing healthcare professionals and the public that on October 25, 2011, Eli Lilly and Company announced a worldwide voluntary market withdrawal of Xigris. In a recent study, Xigris failed to show a survival benefit for patients with severe sepsis and septic shock.

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.

In a recently completed clinical trial, the PROWESS-SHOCK trial, Xigris failed to show a survival benefit. In this trial of 1696 patients, 851 patients were enrolled in the Xigris arm and 845 patients were enrolled in the placebo arm. Results based on preliminary analyses done by Eli Lilly and Company, that were submitted to the FDA, showed a 28-day all cause mortality rate of 26.4% in Xigris-treated patients compared to 24.2% in placebo-treated patients, equivalent to a relative risk of 1.09; with a p-value of 0.31, which is not statistically significant.

FDA previously issued an early communication about the ongoing safety review of Xigris in February 2009.

Narrator: Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information. A link to this communication can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.