FDA Black Box Warning for 2 Eczema Drugs

The labels on two prescription creams to treat eczema will have to bear "black box" warnings of possible cancer risks. The Food and Drug Administration action Thursday follows an agency advisory committee recommendation last February that Elidel cream and Protopic ointment carry the label warnings.

The new labeling also will clarify that the two drugs are recommended for use only after other prescription topical medicines have been tried by patients, the FDA said. The agency is also issuing a guide updating patients of its concerns. As of October, the FDA has received reports of 78 cases of cancers, including skin and lymphoma, in patients treated with the two drugs, said Dr. Stanka Kukich, the acting director of the FDA's dermatologic and dental drug products division. Estimates are that roughly 10 million people combined have used the two drugs.

Courtesy of AP