Federal regulators have called on health care professionals to stop treating sepsis patients with Xigris, an Eli Lilly & Co. drug that researchers say does not work and may expose users to increased risk of bleeding death.
A Xigris recall was announced on Tuesday, after an analysis of a clinical trial revealed that the drug does not provide any benefit.
The trial came after the FDA launched a review of Xigris side effects in 2009, in response to concerns that the medication may increase the risks of bleeding death in some patients.
The FDA is telling doctors not to begin any new patients on Xigris treatment and to end treatment on patients currently taking the drug.
Eli Lilly recently completed a clinical trial of Xigris efficacy called PROWESS-SHOCK that looked at 1696 patients, about half of whom were treated with a placebo. The findings indicate that there was only about a 2% difference in the survival rate of patients given Xigris to treat septic shock when compared to patients on a sugar pill. The FDA says the difference is not statistically significant.
Sepsis, which is also referred to as blood poisoning, is a potentially life-threatening condition which is characterized by a whole-body inflammatory state. It can cause inflammation of the blood vessels, formation of blood clots and lead to acute organ failure in severe cases.
Xigris (drotrecogin alfa) was introduced in 2001 after the the medication was narrowly allowed onto the market following a split decision by an FDA advisory panel about whether or not to recommend approval.
Xigris is a synthetic version of the activated protein C, a natural protein found in the body. The drug reduces inflammation, decreases blood clot formation in blood vessels and helps break down blood clots. It is mainly used during intensive care treatment for the reduction of mortality in adults with severe sepsis who already have a high risk of death.
The FDA began reviewing Xigris following a study that found a high rate of bleeding deaths linked to Xigris use. The retrospective review of patient records looked at 73 Xigris patients and found that out of 20 patients who were identified as having a bleeding risk factor, 7 (35%) suffered serious bleeding events after receiving Xigris and 13 (65%) died. For the other 53 patients, who did not have any bleeding risk factors, only 2 (3.8%) had serious bleeding events and 13 (24.5%) died.
The FDA stated that all remaining Xigris on the market should be returned to the supplier from whom it was purchased.