Drug Recall Lawyer

Xigris

Xigris Has Been Withdrawn From The Market

The Food and Drug Administration has notified healthcare professionals and the public that as of October 25, 2011, Eli Lilly and Company has withdrawn Xigris [drotrecogin alfa (activated)] from the market on a worldwide basis.  The reason for the withdrawal was a recently completed clinical trial, called the PROWESS-SHOCK trial, that failed to show a survival benefit for the drug.  Xigris is a drug given to patients with severe sepsis (a blood infection) who have a high risk of death.  The recent trial failed to show that Xigris provided a survival benefit for patients with severe sepsis and septic shock.  The FDA has recommended that Xigris treatment should not be started in new patients and those on the drug should be taken off.  Further, the FDA has indicated that the drug should be returned to the suppliers.

Previously, in February of 2009 the FDA had issued an Early Communication about an Ongoing Safety Review of the drug, indicating that a study published at that time showed an increased risk of bleeding and death associated with the drug.  In the recent PROWESS-SHOCK trial, the results actually showed a higher mortality rate in people taking Xigris than in people taking placebo.  Xigris was approved by the FDA for use in the U.S. for treatment of patients with severe sepsis in November of 2001.  It was approved by the European Medical Agency in 2002.

Lilly's Senior Vice President and Chief Medical Officer, Timothy Garnett, M.D., stated that "While there were no new safety findings, the study failed to demonstrate that Xigris improved patient survival and thus calls into question the benefit-risk profile of Xigris and its continued use."

If you know someone who was given Xigris for sepsis, a blood infection, and later died, please contact our drug recall lawyers or call 855.646.4355.  Our Xigris lawyer can help you evaluate the situation and determine whether a lawsuit should be filed.  We represent clients nationwide, including the states of Alabama, Florida, Mississippi, and the cities of Mobile, Pascagoula, Biloxi, Gulfport, Pensacola and all of Mobile and Baldwin Counties.