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FDA Approves 1st Drug for Severe Sepsis
Posted by: Dr. Mercola
December 05 2001 | 1,202 views

By Justin Gillis

On November 21 the Food and Drug Administration approved the first treatment for severe sepsis, an overwhelming infection that kills more than 200,000 people a year. The approval comes after two decades of research into potential treatments for the condition.

The drug, drotrecogin alfa, was brought to market by Eli Lilly & Co. of Indianapolis and will be sold under the brand name Xigris (rhymes with tigress).

Sepsis is a systemic infection that can, in the worst cases, overwhelm a person's body, leading to organ failure and death. Until yesterday, drug after drug designed to treat it had failed in human tests.

Lilly's drug was approved only for the sickest patients. Tests showed that Xigris reduced the death rate in that group from 44 percent to 31 percent. Research is continuing on whether the drug can benefit patients who are less ill, but that was not proven in the largest test conducted.

The main risk of the drug seemed to be an elevated chance of certain kinds of bleeding, including stroke.

Washington Post November 22, 2001; Page A05



Dr. Mercola's Comments:
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Well, we now have a new potent drug in our arsenal to treat serious infections. I am certain that it will save many lives. It took Lilly scientists nearly two decades to figure out how to derive large quantities of the protein C molecule.

This research has to be paid for, and of course, this drug will not be cheap. It will not be something you purchase at the corner drug store.

This new drug is expected to come with an astronomical price tag. Estimates range from $1,000 to $10,000 a dose, and many specialists expect the figure initially to be around $5,000 a dose.

Industry analysts say annual sales of Xigris could approach or exceed the $2.6 billion that Prozac had at its peak.

So, you will either have to have insurance, or have huge source of income to afford this drug.

Of course Xigris also has a serious side effect in some patients; serious bleeding that will likely kill some patients.






 
 
 
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