New Warnings for Two Eczema Drugs

Two topical eczema drugs now carry a “black box” warning about a possible risk of cancer. The FDA approved the updated labeling with the warning for Elidel Cream (pimecrolimus) and Protopic Ointment (tacrolimus). The agency also approved a consumer-friendly medication guide that pharmacists are required to give to patients when dispensing these prescription drugs to make them aware of this concern.

The new labeling also clarifies that these drugs are recommended for use as second-line treatments, meaning that other prescription topical medicines should be tried first. Use of these drugs in children younger than 2 is not recommended.

People who have eczema, or atopic dermatitis, have chronic itching and dry skin. Both drugs are applied to the skin to help control eczema.

Although a causal link has not been established, rare reports of cancer have been reported in people who had been using these products.

Studies are being conducted by the manufacturers of both drugs to try to answer questions about cancer risk, but it could be many years before the research is concluded. In the meantime, there is a benefit associated with these drugs when used appropriately.

Novartis Pharmaceuticals Corp. manufactures Elidel Cream and Astellas Pharma Inc., formerly Fujisawa Healthcare, manufactures Protopic Ointment.