The United States Food and Drug Administration (“FDA”) notified healthcare professionals and the public that on October 25, 2011, Eli Lilly and Company announced a worldwide voluntary market withdrawal of Xigris (chemical name is drotrecogin alfa) because Xigris failed to show a survival benefit in the recently completed clinical trial (PROWESS-SHOCK trial). Xigris failed to show a survival benefit for patients with severe sepsis and septic shock.
Xigris was marketed to control sepsis, a condition that occurs in up to 2 percent of all hospitalizations in the United States. Sepsis is a severe and often life-threatening illness that can cause shock, shut down multiple organs, and can lead to death. In the most recent study, Xigris was found to have limited benefit in treating sepsis while having risks to patient health. Although the intravenous drug had been found to increase the risk of serious bleeding in earlier studies, no significant higher risk was found in the latest PROWESS-SHOCK study which found the drug ineffective.
“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,” Timothy Garnett, Lilly’s chief medical officer, said in a statement on Tuesday. The FDA and Lilly have stated publicly that patients currently receiving Xigris treatment should stop, while doctors should not start any new patients on the drug.
The PROWESS-SHOCK study began in March 2008 as a condition for continued European approval. Results of the 1,696-patient study showed that patients taking Xigris did not have a statistically significant reduction in deaths from any cause over a 28-day period in patients with septic shock. According to European Medicines Agency, 26.4 percent of patients taking Xigris died compared with 24.2 percent taking a placebo, a difference that was not deemed statistically significant.
“So the incremental benefit of Xigris is no longer apparent, and no longer clinically relevant,” Lilly’s Garnett acknowledged.
If you or a loved one has experienced serious bleeding or other complications, including death from sepsis, after being treated with the intravenous medication Xigris, you may have a lawsuit that should be pursued. Our drug litigation practice is national in scope, and, together with attorneys licensed in your state, our Xigris lawyers are prepared to file lawsuits and litigate Xigris cases around the country. Our attorneys can help to ascertain if you have an Xigris claim for which a lawsuit can be pursued and whether the case and lawsuit can be brought to a successful settlement, verdict, award, or other recovery. The experienced lawyer will also be able to advise you on any deadlines for bringing your legal claim for damages.
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