An FDA advisory committee had recommended last February that Elidel cream and Protopic ointment bear the "black box" warnings, reports Reuters
The new labeling must also say that the drugs are recommended only after other prescription creams have been tried, the FDA said.
"This is something that is a possible risk -- is a long-term possibility and is something that still needs to be researched," FDA spokeswoman Susan Cruzan said.
The maker of Elidel, Novartis AG, said in a statement that it is confident in the safety of its product.
"While Novartis believes this action is not substantiated by scientific or clinical evidence, Novartis has agreed to make the requested changes," the company said.
