According to a recent Drug & Safety Communication, The U.S. Food and Drug Administration (FDA) is informing healthcare professionals and the public that on October 25, 2011, Eli Lilly and Company announced a worldwide voluntary market withdrawal of Xigris. In a recent study, Xigris failed to show a survival benefit for patients with severe sepsis and septic shock.
Xigris is used solely in hospital intensive care units to treat patients at a high risk of death due to serious complications of sepsis and septic shock.
They have asked health care professionals to stop treating sepsis patients with Xigris, because researchers say it does not work and may expose users to increased risk of bleeding death.
So in other terms, patients that are already very ill, have a greater risk of dying after being treated with this medication!
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 now 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. According to a report from IndyStar.com, Eli Lilly spent hundreds of millions of dollars to develop Xigris, but during its quest for approval a decade ago, failed to get a clear endorsement from an FDA review panel. Some on the panel questioned the way some of the drug’s clinical trials where handled, and only half of the advisors on the 20-member panel voted in favor of 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.
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