Xigris, a treatment for severe sepsis, is being removed from the market because it does not help prevent patients with the condition from dying, according to a safety alert issued by the Food and Drug Administration (FDA).

Sepsis is a potentially deadly illness in which the bloodstream is overwhelmed by bacteria. In sepsis, blood pressure drops which can result in shock. Major organs and body systems, including the kidney, liver, lungs, and central nervous system, stop working properly. Symptoms range from chills and confusion to fever or low body temperature, shaking and skin rash. The condition is often life threatening, especially in people with a weakened immune system or with a chronic illness.

Xigris (drotrecogin alfa), made by Eli Lilly and Company, was indicated for patients with severe sepsis or septic shock who were at high risk of death. According to a recently completed clinical trial (PROWESS-SHOCK trial) Xigris failed to show a survival benefit. In this trial of 1,696 patients, 851 received Xigris and 845 received a placebo. After 28 days, 26.4 patients in the Xigris group died, compared to 24.2 deaths in the placebo group. The FDA had previously issued an early communication about the ongoing safety review of Xigris in February 2009.

Xigris is being withdrawn from the marketplace worldwide. The FDA indicates treatment with Xigris should not be started in new patients, and it should be stopped in patients currently being treated with the drug. All remaining Xigris products should be returned to the supplier from whom it was purchased.

Source: FDA