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FDA Approves New Eczema Therapy
By LAURAN NEERGAARD
.c The Associated Press
WASHINGTON (AP) - The first new type of drug in decades to treat the troubling skin disease eczema won government approval Friday: an ointment named Protopic that can ease the often severe itching of both adults and children.
The Food and Drug Administration cautioned that Protopic shouldn't be the first therapy for all patients, but reserved for those with moderate to severe eczema who aren't adequately helped by other treatments or can't tolerate them.
The manufacturer, Japan's Fugisawa Healthcare, plans to begin shipping the prescription cream in February, but refused to disclose the price.
Eczema is a skin inflammation that causes itching and oozing lesions that recur often, sometimes starting in infancy and plaguing patients throughout their lives. Just what causes it is unknown, although people with allergic disorders seem at higher risk.
There is no cure, but corticosteroid creams, antihistamines and, as a last resort for severe cases, steroid-containing pills are common treatments. Doctors caution that steroid medications, even cream versions, can cause some serious side effects and must be used very carefully.
So patients have long hoped for new alternatives.
Protopic is the first topical immune-suppressing drug, a cream version of an immune-system inhibitor called tacrolimus that, in oral and intravenous versions, already is used to help prevent rejection in organ transplant recipients.
The theory is that the cream version helps eczema by inhibiting immune-system cells called T cells that may be overactive in the skin inflammation.
In clinical studies, between 28 percent and 37 percent of patients who used Protopic daily for three months found it cleared up most of their eczema outbreak, compared with only 7 percent who had success with a dummy cream.
It was not a cure: Once people quit using the cream, eczema gradually returned. So far, the FDA can say only that using it for a year is safe; Fugisawa agreed to conduct longer-term safety studies.
"It is important to have this alternative because there are patients who suffer" serious problems from standard eczema therapies, said FDA medical officer Dr. Martin Okun.
But Protopic isn't risk-free, he warned:
Users should stay out of the sun. Because Protopic affects the immune system, some scientists worry that it might mix with sun exposure to increase the risk of skin cancer. The possibility remains under study.
Don't use Protopic until skin infections are healed. The drug may increase risk of certain skin infections, including a serious herpes virus-caused infection called eczema herpeticum.
Most common side effects were skin burning or tingling in up to 60 percent of patients. But after a month of use, less than 10 percent report that continues to be a problem.
On the Net: American Academy of Dermatology: http://www.skincarephysicians.com/eczemanet/index.htm
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