Xigris May Cause Blood Infections. October 25,2011: Health Canada to withdraw Xigris from Canadian Market!
The Canadian Health Department (Health Canada) issued a statement informing Canadians that it is working with Eli Lilly Canada to withdraw Xigris (drotrecogin alfa) from the Canadian market, in light of the company’s decision to withdraw Xigris from the market worldwide. Read more from Health Canada here…
Read the Eli Lilly News Release about Xigris recall following PROWESS-SHOCK test results study
Eli Lilly and Co.’s sepsis treatment Xigris has been the focus of intense scrutiny since the U.S. Food and Drug Administration approved it in November 2001. It was approved despite an FDA advisory panel’s split decision on whether or not to recommend approval. The FDA has required Lilly to conduct a number of additional trials, including a current study of adult patients with severe sepsis who were at low risk of death.
Xigris is Linked to an Often-Fatal Blood Infection
A drug approved in the United States for treating severe sepsis, Xigris is linked to an often-fatal blood infection accompanied by acute organ failure. For less severely ill septic patients, drotrecogin alfa (activated), the first bioengineered drug therapy for the treatment of sepsis, appears to be no more effective than a placebo in reducing death. It also poses a serious risk of bleeding and should not be used, an international research team has concluded. The multi-center trial to test the effects of the drug in low death-risk patients was terminated early when an interim analysis of data showed little chance it would reduce the risk of death.
Here’s a drug that’s potentially harmful, that causes increased bleeding episodes in patients, and if there’s no evidence of any benefit, really the appropriate thing to do is to stop the study,” explained lead author Dr. Edward Abraham, co-head of the division of pulmonary sciences and critical care medicine at the University of Colorado Health Sciences Center in Denver.
Severe sepsis kills 215,000 people in the United States each year, according to the Society of Critical Care Medicine. It often develops from infections associated with pneumonia, trauma, surgery, burns, or cancer, and can cause clotting and inflammation in the blood vessels. Drotrecogin alfa (activated) is a genetically engineered version of the activated protein C, a naturally occurring substance that regulates blood clotting, controls inflammation, and helps break down clots.