The US Food and Drug Administration (FDA) announced in an early communication that it is conducting a safety review of an Eli Lilly & Co. (LLY) drug. The drug in question is a recombinant human activated protein C indicated for the treatment of severe sepsis, and a recent study indicated the drug could increase the risk of serious bleeding and death.

Posted Wednesday on the FDA's Web site, the agency communication said it was working with Lilly "to further evaluate the incidence of serious bleeding events and mortality in patients who received Xigris."

An early communication means that the FDA is working on but has not reached a conclusion whether any regulatory action is called for. The FDA is working with the drug manufacturer to evaluate the incidence of serious bleeding and mortality reported to affect patients treated with this drug. The review could take several months to complete and the FDA would forward its findings as well as any recommendations after the review process is completed. The FDA said, "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."

Sepsis is a potentially life-threatening condition that occurs when an infection spreads throughout the bloodstream. The drug Xigris is used as treatment for adults who have severe sepsis and are at a high risk of dying. The drug already has warnings that it could increase the risk of bleeding and death in certain patients and recommends the drug not be used by such patients as those who have had a recent severe head injury.

The study that brought the risks to the forefront was a recently published retrospective study published last month in the journal Critical Care Medicine.

It involved a review of 73 patients who received the drug Xigris and serious bleeding events occurred in 7 or 35 % of 20 patients who had a risk factor for bleeding. In patients who did not have underlying factors that would increase the risk of bleeding, two or 3.8 % of the patients had a bleeding problem. The study also highlighted that more patients with bleeding risks died at 13 or 65% of 20 patients as compared to patients with no bleeding risks at 13 or 24.5 % of 53 patients.

In a statement, a Lilly spokesman said, "there are appropriate disclaimers in the warnings section for the physician to carefully assess the potential benefit versus risk of using Xigris in these very ill patients."