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Katie: While checking out LevLarry's post in regard to minocin I came across this article, which I thought might be of interest to you and Justin:

FDA OKs Tysabri for Crohn's Disease

By Miranda Hitti
WebMD Medical News Reviewed by Louise Chang, MD

Jan. 14, 2008 -- The FDA today approved the multiple sclerosis drug Tysabri for the treatment of Crohn's disease.

Tysabri may be used to treat patients who have moderate to severe Crohn's disease with evidence of inflammation who don't adequately respond to or can't tolerate other Crohn's disease therapies.

Tysabri, a biologic drug given by health care professionals at infusion centers, carries a "black box" warning (the FDA's sternest warning) about the risk of a rare, serious brain disease called progressive multifocal leukoencephalopathy (PML).

Tysabri was taken off the market in February 2005 because of that risk. The drug returned to the market in June 2006 under a restricted distribution program after no new cases of PML were seen in patients who had taken Tysabri prior to the drug's suspension.

Crohn's patients who take Tysabri -- and doctors, infusion centers, and pharmacies that provide Tysabri -- must enroll in the restricted Crohn's Disease Tysabri Outreach Unified Commitment to Health, or CD TOUCH, prescribing program.

"With the addition of Tysabri to the treatment options for sufferers of Crohn's disease, we make an important step in the armamentarium for treatment, but one that carries serious risks," Joyce Korvick, MD, deputy director of the FDA's division of gastroenterology products, told reporters. "Health care providers must carefully monitor patients for these risks."

Korvick also confirmed that no new cases of PML have been reported in Tysabri users since the drug returned to market. Tysabri's makers, Biogen Idec and Elan, will conduct long-term surveillance studies of Tysabri, including monitoring PML cases, says Korvick.


watchingwolf39464.3707407407

Yes ma'am! Thank you! I did catch a bit of it the other day when I was sick................aka, I don't remember much of it. LOL

Thank you for refreshing my memory! I'll admit, the only really discouraging part is the damn price. As always though, right? They said it would be around ,000. HAH! *sigh* Still, it's a marching step in the right direction.


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