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In addition, FDA has given notice that it is reviewing safety data for drotrecogin alfa (activated), marketed as Xigris, following a study (Gentry et al., Crit Care Med 2009;37:19-25) that reported an increased risk of serious bleeding events and death in patients with sepsis and baseline bleeding risk factors who received this product.
FDA notes the findings in this study are consistent with the information in the current product label and the agency is not recommending any changes in practice at this time. The agency will communicate its conclusions and any resulting recommendations to the public when the review is completed, which may take several months. FDA urges both health care professionals and patients to report side effects from the use of drotrecogin alfa to the FDA's MedWatch Adverse Event Reporting program.
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