xigris recall from the market
Xigris® recalled from the market

Xigris® (drotrecogin alfa), a synthetic version of protein C, which is a natural protein found in the body, was introduced in 2001. It was prescribed to treat patients that were diagnosed with severe cases of Sepsis and is used to reduce inflammation, decrease blood clotting, and break down current blood clots.

Sepsis, or blood poisoning, is a life threatening condition. This illness causes inflammation of blood vessels, blood clots, and may also lead to organ failure in severe cases.

Reports state that federal health regulators are pleading with health care professionals to stop prescribing Xigris to patients that have been diagnosed with Sepsis. Researchers believe that the drug actually increases the risk of bleeding to death rather than reducing the risk.

In 2009, the Food and Drug Administration (FDA) launched a review of Xigris due to a study which linked use of Xigris to a high rate of bleeding deaths. About 73 patients were reviewed, 20 of those patients were identified as having a risk of bleeding death, 7 suffered severe bleeding after taking Xigris, and 13 ultimately died. Since then, the FDA has advised doctors not to prescribe any new patients with the drug. The FDA also recommends that doctors ask patients that are currently using the drug to stop use immediately.

On Tuesday, October 25th, a Xigris recall was announced due to the conclusion from a clinical trial which proved that the drug provides no benefits. Results showed that about 2% of patients prescribed Xigris survive septic shock compared to patients prescribed sugar pills. This trial studied 1,696 patients, half of which were treated with placebo. The FDA noted from this study that Xigris provides no significant benefits. The FDA has also suggested that all consumers that have purchased Xigris return the product back to its suppliers.


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