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news.The American Academy of Dermatology has issued a statement defending Novartis and Fujisawa's eczema medications after the FDA announced that it will add a black box warning to the products' labels.
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The Academy, the largest of all dermatologic associations, said that it was disappointed with the FDA’s action and that there is no data to prove that proper topical use of Novartis’ Elidel (pimecrolimus) and Fujisawa’s Protopic (tacrolimus) is dangerous in humans.
“Because these medications are applied to the skin, virtually none of it gets inside the body. It’s not the same as taking a pill,” explained dermatologist Dr Clay Cockerell, president of the Academy.
“These are valuable medications, and if used properly, they significantly reduce the debilitating impact of eczema and allow millions of our patients to live normal lives,” he continued.
On February 15, 2005, a dermatologist spoke on behalf of the Academy at an FDA pediatric advisory committee hearing, urging the FDA not to impose a black box warning or other labeling restrictions because such steps could limit access to these medications, or limit treatment options if qualified patients decide not to use these medications based on fear of a cancer risk.
Advocates representing eczema patients, such as the Inflammatory Skin Disease Institute (ISDI), have also spoken out against more restrictive labeling.