February 18, 2005
FDA weighs black box warning for two eczema creams
The FDA convened an outside panel of experts this week to consider adding black box labeling to two prescription eczema creams to warn they might increase the risk of certain cancers, especially in children. The panel discussed Novartis' Elidel and Fujisawa Pharmaceuticals' Protopic after 13 reports of skin cancer and lymphoma in children and adults. Novartis said there was no evidence
Elidel causes lymphoma, noting the number of lymphomas in question "is below the number typically observed in the general population." Fujisawa said it did not believe Protopic raised the risk of skin cancer or lymphoma and that the cream "has a favorable benefit-risk ratio."