The Food & Drug Administration (FDA) is reviewing the sepsis treatment, Xigris, after a study showed that the drug increased the risk of death in people with bleeding problems.

The study cited by the FDA Early Communication announcing the Xigris review followed 73 sepsis patients who were treated with Xigris.  The study found that serious internal bleeding occurred in 35 percent of patients with a history of bleeding problems, compared with 3.8 percent of patients with no such history.

The FDA said it plans to consult with Xigris maker Eli Lilly and reevaluate the drug’s labeling in the coming months. The agency said prescribers should refer to the product label for the specific contraindications, warnings, and precautions.  The should carefully weigh the increased risk of bleeding against the benefits of Xigris.

The current prescribing information for Xigris describes the increased risk of bleeding, and includes a statement in the Warnings and Precautions section that bleeding is the most common serious adverse reaction experienced by patients who received the drug. The Warnings and Precautions section also lists a number of risk factors for the increased risk of bleeding that should be taken into account when considering use of Xigris therapy. The Contraindications section states that Xigris is not to be used in the following clinical situations where bleeding could lead to significant morbidity or death:

• Active internal bleeding
• Recent (within 3 months) hemorrhagic stroke
• Recent (within 2 months) intracranial or intraspinal surgery, or severe head trauma
• Trauma with an increased risk of life threatening bleeding
• Presence of an epidural catheter
• Intracranial neoplasm or mass lesion or evidence of cerebral herniation