FDA to examine bleeding with Lilly''s Xigris

WASHINGTON (Reuters) - U.S. health regulators are taking a closer look at the possible risk of serious bleeding with Eli Lilly and Co''s Xigris that is used to treat severe sepsis and whether some patients should not be given the drug.

The action comes after a retrospective study of 73 sepsis patients who took Xigris found that they had an increased risk of serious bleeding and death, the U.S. Food and Drug Administration said on Wednesday. The study was published last month in the journal Critical Care Medicine.

Xigris, also known by its generic name drotrecogin alfa, treats bloodstream infections, or sepsis, in adults. Its label already describes the increased risk of bleeding, the FDA said in a notice on its web site.

"Overall, the finding...of an increased risk of death and serious bleeding events in patients treated with Xigris who also have baseline bleeding risk factors is consistent with the information in the current product label," it wrote.

But an editorial accompanying the study called for doctors not to give the drug to any sepsis patients who are at risk for bleeding problems, "effectively changing a warning in the product labeling to a contraindication," the FDA added.

The FDA said it was working with Lilly to evaluate the incidence of serious bleeding and death in Xigris patients, but that it could take several months before the agency makes any recommendations.

Representatives for Eli Lilly were not immediately available for comment.

Shares of the company were up 13 cents at $38.82 in morning New York Stock Exchange trade.

The FDA posted its statement on its website here