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Last week, I posted an article about the strong links regarding the increase in certain cancers and the use of Protopic and Elidel, two prescription skin creams. After much prompting from researchers who discovered the link, the FDA ruled late yesterday both Protopic and Elidel would have "black box" warnings about such risks.
According to the FDA ruling, both drugs aren't approved for use by children younger than 2 because research had shown "the risk of cancer increased as the amount of the drug given increased" as well as a small number of reports of cancers in children and adults.
Not surprisingly, Novartis, the maker of Elidel, disputed the black box warning as did the American Academy of Dermatology who claims the body absorbs little, if any, of the drug.
The black box ruling is a bit of a surprise because, according to reports, the FDA typically negotiates labeling with drugmakers. But not terribly unexpected, considering all the attention Congress has paid toward the FDA and its all-too-cozy relationship with the mega-bilion drugmakers.
Yahoo News March 11, 2005