Eczema treatments prompt new warnings

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Eczema treatments prompt new warnings

Eczema treatments Elidel and Protopic now carry cautions about their long-term safety.

What happened: On Jan. 19, 2006, the Food and Drug Administration (FDA) approved new label warnings for two eczema drugs, Elidel Cream (pimecrolimus) and Protopic Ointment (tacrolimus). The boxed warnings caution users about the possible risk of cancer and note that long-term safety of these medications has not yet been established.

There have been rare reports of cancer (for example, skin cancer and lymphoma) in people using these products long term. Though no direct cause has been established, the FDA is warning of the possible risk to assure the medications are used only as directed, until further studies are available.

Eczema, also referred to as atopic dermatitis, is a chronic condition that causes itchy, inflamed skin. It tends to flare periodically and then subside for as long as several years. The exact cause of eczema is unknown, but it may result from a malfunction in the body's immune system.

Elidel and Protopic are eczema treatments. They're in a class of medications called immunomodulators, which affect the immune system to help reduce flares of atopic dermatitis, and thus maintain normal skin texture.

Due to possible concerns about the effect of these medications on the immune system when used for prolonged periods of time, the FDA recommends that Elidel and Protopic be used as second-line therapies. This means they would be used only when other treatments have failed, or if you can't tolerate other treatments. The drugs aren't recommended for children under age 2.

What does this mean to you? If used as directed, these medications can lessen the symptoms of eczema. But they're only intended for short-term treatment. If you need to use Elidel or Protopic for prolonged periods, your doctor may recommend that you use them intermittently. Talk with your doctor about your options if you're taking one of these medications.

Last Updated: 01/23/2006
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