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FDA Issues Early Communication about a Safety Review of Xigris

February 4, 2009 -- The U.S. Food and Drug Administration today 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 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. 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.

The FDA is not recommending that prescribers stop administering this medication. Consumers and health care professionals should notify the 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

The FDA uses a variety of tools to communicate important and sometimes emerging drug safety information. Early Communications mean that the FDA has begun an ongoing safety review about an important drug safety issue that has not yet been fully analyzed or confirmed by the agency. The FDA will announce its conclusions and any resulting recommendations to the public when the review of Xigris is completed, which may take several months.

The full Early Communication can be found here:

Source: Food and Drug Administration

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