Regulators in the USA have announced that they are looking into an increased risk of serious bleeding events and death in patients with sepsis who have received Eli Lilly’s Xigris
The US Food and Drug Administration says that it is acting on the back of a retrospective study of 73 patients who took Xigris (drotrecogin alfa) a recombinant human activated protein C indicated for the reduction of mortality in adults with severe sepsis who have a high risk of death. The label on the drug already describes the increased risk of bleeding, the FDA said in a notice on its website.
Overall, the study’s finding 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,” the FDA says.
But an editorial accompanying the study, which was published last month in the journal Critical Care Medicine, called for doctors not to administer Xigris to any sepsis patients who are at risk for bleeding problems. This means “effectively changing a warning in the product labelling to a contraindication,” the FDA added.
The agency noted that it is working with Lilly to evaluate the incidence of serious bleeding and death in Xigris patients, but that it could take several months before it makes any recommendations. For its part, the company believes that the current approved label for Xigris is appropriate.
