FDA Reviews Sepsis Drug Xigris

U.S. health officials are reviewing cases of serious bleeding in patients taking the drug Xigris, which is used to treat severe sepsis (bloodstream infection).

A recently published study showed that the injectable drug increased the risk of dangerous internal bleeding when taken by patients with a recent history of hemorrhages, the U.S. Food and Drug Administration said Wednesday, the Associated Press reported.

The study of 73 patients treated with the Eli Lilly drug found that serious bleeding occurred in 35 percent of patients with a history of bleeding problems, compared with 3.8 percent of other patients.

Xigris already carries a warning that internal bleeding is a serious effect, but the FDA plans to work with Eli Lilly to reassess the drug's risks, the AP reported.

Patients taking Xigris should not stop taking the drug, the FDA said.

Tags:

• Heart & Blood