Study Prompts FDA Safety Review of Xigris

Study Shows Increased Risk of Death

The US Food and Drug Administration (FDA) has announced that it is working with the maker of Xigris (drotrecogin alfa activated), Eli Lilly and Company, to further evaluate the incidence of serious bleeding events and death in patients who receive Xigris, a drug used to treat severe sepsis (a blood stream infection). A recent study and an accompanying editorial published in the journal Critical Care Medicine reported an increased risk of serious bleeding events and death in patients with sepsis and baseline bleeding risk factors who received Xigris.

The study, a retrospective review of medical records of 73 patients who were treated with Xigris, found that serious bleeding events occurred in seven of 20 patients (35 percent) who had a bleeding risk factor versus 2 of 53 (3.8 percent) of patients without any bleeding risk factors.

More patients with baseline bleeding risk factors died (13 of 20, or 65 percent) compared with patients without any bleeding risk factors (13 of 53, or 24.5 percent).

Xigris is known to increase the risk of bleeding. The drug's current prescribing information (labeling) includes a warning that describes bleeding as the most common serious adverse effect and lists a number of risk factors that should be carefully considered when deciding whether to use Xigris. The labeling contraindicates the use of Xigris in several clinical situations where bleeding could lead to significant adverse reactions or death. This latest study is cause for further concern.

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Published on Feb-4-09