Lilly's Sepsis Drug Draws FDA Scrutiny

The FDA has said a study of Xigris shows an increased incidence of bleeding in some patients.
Publish date:

Updated from 3:35 p.m. EST

The good cheer aroused by

Eli Lilly's

(LLY) - Get Report

blood thinner


was tempered somewhat Wednesday by a report that the FDA was investigating an increased incidence of bleeding in another of the company's drugs, Xigris.

The Food and Drug Administration said Wednesday that a retrospective, 73-patient study of Lilly's Xigris, which is used to treat patients with sepsis, a type of blood poisoning, showed an increased the risk of internal bleeding in those with a recent history of hemorrhages.

Lilly said the drug's label indicates potential side effects, including an increased risk of bleeding. The company also said the study in question wasn't set up to evaluate patients who'd recently hemmorrhaged.

The FDA agreed that the label outlined the side effects. According to the agency's

Web site


The finding by Gentry et al. 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. Prescribers should refer to the product label for the specific contraindications, warnings, and, precautions and carefully weigh the increased risk of bleeding against the benefits of Xigris. FDA is working with the manufacturer to further evaluate the incidence of serious bleeding events and mortality in patients who received Xigris. FDA will communicate its conclusions and any resulting recommendations to the public when the review is completed, which may take several months.The FDA urges both healthcare professionals and patients to report side effects from the use of Xigris to the FDA's MedWatch Adverse Event Reporting program.

The FDA approved Xigris in 2001. Sales of the drug were about $161 million in 2008, down from $183 million in 2007.

Eli Lilly shares were down 1.6% to $38.06 in recent trading. Among its direct competitors, only


(GSK) - Get Report

was in the green, barely ticking up 0.6% to $36.56.

Novo Nordisk

(NVO) - Get Report

was down 3.7% to $53.71, and


(PFE) - Get Report

was down 2% to $14.58.