FDA has approved a new treatment for eczema, a skin condition that can cause redness, itching, and oozing lesions. Protopic Ointment is for patients with moderate to severe eczema who are unable to tolerate or benefit from standard eczema therapies.

FDA based its approval on results of three 12-week studies that indicated that 28 to 37 percent of patients using Protopic experienced greater than or equal to 90 percent improvement of their skin condition. Two one-year studies indicated the drug is safe for intermittent long-term use. Common side effects associated with this drug include temporary stinging or burning sensations where the drug is applied.

An animal study revealed that Protopic Ointment may accentuate adverse effects of ultraviolet light on the skin. So patients should avoid sunlight and sunlamps, tanning beds, and treatment with ultraviolet A (UVA) or ultraviolet B (UVB) light. Patients who need to be outdoors after applying Protopic should wear loose-fitting clothing that protects the treated area from the sun. Patients should also ask their health-care providers about other sun protection to use.

Protopic Ointment should not be used by patients who are allergic to its active ingredient, tacrolimus, or to its inactive ingredients. Women who are breast-feeding should also avoid using the ointment, and women who are pregnant or planning to become pregnant should check with their physicians before using this product.

Protopic will be marketed by Fujisawa Healthcare Inc. of Deerfield, Ill.