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Xigris (Drotrecogin alfa (activated)) - Early Communication about an Ongoing Safety Review

Audience: Critical care healthcare professionals

[Posted 02/04/2009] FDA is aware of a recently published study, a retrospective medical record review of 73 patients who receive Drotrecogin alfa (activated), marketed as Xigris, indicated for the reduction of mortality in adult patients with severe sepsis who have a high risk of death (Gentry et al.; Crit Care Med 2009).The study reported an increased risk of serious bleeding events and of death in patients with sepsis and baseline bleeding risk factors who received this product. Serious bleeding events occurred in 7 of 20 patients (35%) who had a bleeding risk factor vs. only 2 of 53 (3.8%) patients without any bleeding risk factors. 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.

[February 04, 2009 - Early Communication about an Ongoing Safety Review - FDA]