Eczema Drugs Get Cancer-Risk Warnings

January 2006

The Food and Drug Administration (FDA) announced two eczema products are getting “black box” warnings, the most severe type of prescription drug warning issued by the FDA. Elidel and Protopic must now display “black box” labels because of potential cancer risks associated with the drugs.

Both prescription drugs are topical treatments for eczema, a condition that causes dry, scaly patches on the skin that can itch and bleed. Eczema, also known as atopic dermatitis, affects 10%-15% of the child-age population, according to the FDA. The warning comes after animal studies suggested a cancer link, and after a dozen reports of skin cancer and lymphoma were seen among patients.

The FDA recommends the use of Elidel and Protopic only after other treatments for eczema have failed. Children and adults with weakened immune systems should not use the drugs.

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