Xigris Bleeding and Death Side Effects Lead to FDA Safety Review

The FDA has issued an Early Communication about an ongoing safety review into Xigris side effects which may increase the risk of serious bleeding events and death when used in patients with sepsis and baseline bleeding risk factors.

Xigris (drotrecogin alfa), which is manufactured by Eli Lilly & Co., was introduced in 2001 after the the narrowly approved the medication following a split decision of their advisory panel about whether or not to recommend approval.

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.

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 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.

According to an Early Communication issued by the FDA on February 4, 2009, the agency is looking into possible side effects of Xigris which may increase the incidence of serious bleeding and death among certain patients.

The announcement comes following a recent study published in the journal Critical Care Medicine, which was a retrospective review of records for 73 patients treated with Xigris. 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.

Xigris bleeding side effects are already known and included as a warning on the drug’s current label, but the FDA indicates that they will be working with Eli Lilly to reassess the bleeding risks and determine whether any regulatory actions or stronger warnings may be necessary.

The FDA has not recommended that doctors stop prescribing the drug, and an Early Communication does not mean that a causal connection has been established between the emerging safety concern and Xigris side effects.

After the drug review is completed, a process that may take several months, the FDA will announce its conclusions to the public and also do what is needed for any further recommendations or regulatory action.