FDAnews
www.fdanews.com/articles/71750-lilly-stops-pediatric-trial-of-sepsis-drug

Lilly Stops Pediatric Trial of Sepsis Drug

April 29, 2005

Eli Lilly stopped a study of its Xigris injection in children because the drug was no more effective than a placebo for treating severe sepsis, U.S. regulators and the company said. The study of about 400 children also showed more of those treated with Xigris experienced central nervous system bleeding, the Food and Drug Administration said. Four children developed brain hemorrhages over the six days of Xigris treatment, compared with one in the placebo group, the FDA and Lilly said. Three of the four hemorrhages in the Xigris group occurred in infants 60 days old or younger.

Reuters (http://reuters.com/newsArticle.jhtml?type=topNews&storyID=8341736)