Eczema Lawyers

The labels of two medicines used to treat eczema will carry a strong warning of a possible cancer risk, the Food and Drug Administration said Thursday.

An FDA advisory panel in February had recommended relabeling the medicines Elidel and Protopic after several animals developed cancer in drug studies. The FDA issued a public health advisory to doctors in March advising them of the possible cancer risk.

Eczema, a disorder that causes severe itching and dry skin, affects people of all ages, but especially children; 10% to 15% of children have the condition. The FDA approved both drugs as eczema treatments when steroid creams fail. The drugs became widely prescribed because parents believed them to be safer than the steroids.

The label approved by the FDA will carry the agency's strongest caution, a "black box" warning. The label will also emphasize the proper use as a second-line treatment, the FDA said. It also said the drugs should not be used on infants.

"The boxed warning informs health care professionals that the long-term safety of these drugs has not been established," the FDA said in a statement. "Although studies are being conducted by the manufacturers of both drugs to try to answer questions about cancer risk, it could be many years before the research is concluded."

Novartis, maker of Elidel, and Astellas, maker of Protopic, said the drugs are safe in interviews and statements Thursday.

"The changes to the label are focused on a potential risk, not on a proven or known risk," said Joyce Rico, a vice president at Astellas.

The FDA's concern about a cancer risk is based on studies that used high doses, Novartis said in a statement. It said the company agreed to change its label although it believes "this action is not substantiated by scientific or clinical evidence."

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