FDA, Eli Lilly Evaluating the Drug Xigris

The U.S. Food and Drug Administration said yesterday it is investigating cases of serious bleeding associated with Xigris, a drug used to treat severe blood stream infections known as sepsis. The agency said it is working with the maker of Xigris, Eli Lilly and Company, to further evaluate the incidence of serious bleeding events and death in patients receiving the drug.

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 (drotrecogin alfa activated). 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 two 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). As noted by the authors, limitations of this study include the retrospective design (looking back at events that already have taken place) and small patient population.

Xigris is known to increase the risk of bleeding, FDA says. 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.

FDA is not recommending that prescribers stop administering this medication. Consumers and health care professionals should notify FDA of any complaints or problems associated with this product. These reports may be made to MedWatch, the FDA's voluntary reporting program, by calling 800-FDA-1088, or electronically at www.fda.gov/medwatch/report.htm. FDA will announce its conclusions and any resulting recommendations to the public when the review of Xigris is completed, which it said may take several months. For the agency's full Early Communication on the drug, visit www.fda.gov/cder/drug/early_comm/drotrecogin_alfa.html.

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