OTTAWA — The pharmaceutical company Eli Lilly is withdrawing a drug that's used in hospital intensive-care units around the world.
The drug Xigris had been approved for treating patients at high risk of death due to serious complications of a blood infection known as sepsis or septic shock.
The company says the results of its recent PROWESS-SHOCK study showed that use of the drug didn't lead to a statistically significant reduction in 28-day mortality in patients with septic shock.
"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," Dr. Timothy Garnett, Lilly's senior vice-president and chief medical officer, said in a statement Tuesday.
Patients currently receiving treatment with Xigris should have treatment discontinued, and Xigris treatment should not be started for new patients, he said.
"We believe the original Xigris approval was appropriate and these recent results were quite unexpected," Garnett added. "A contributing factor to these study results could be advances in the standard of care for treating severe sepsis over the past 10 years."
Health Canada also issued a statement Tuesday noting that it is working with Eli Lilly on the withdrawal.
More information will be provided to hospitals as soon as it is available, the statement said.
Xigris received approval from the U.S. Food and Drug Administration in 2001 and approval in the European Union in 2002.
The PROWESS-SHOCK study began in March 2008 as a condition for continued market authorization in Europe. Lilly conducted the placebo-controlled clinical trial to help better identify patients for treatment with Xigris and to confirm benefits and risks. User Tools
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