FDA: Eczema drug labels note cancer risk
Improved labeling addresses concern of possible cancer risk from Elidel Cream and Protopic Ointment.
NEW YORK (CNNMoney.com) - The FDA announced improved labeling for two topical eczema drugs, Elidel Cream and Protopic Ointment, which have been linked to rare reports of cancer.
The labeling will be updated with a boxed warning about potential cancer risk.
"We are taking steps to ensure that healthcare providers and patients are aware of the possible long-term risks of these products so that they will be used appropriately," said Dr. Steven Galson, Director of the FDA's Center for Drug Evaluation and Research.
Eczema is a common skin disorder, affecting as much as 15 percent of the childhood population.
The drugs had been of concern since the FDA issued a Public Health Advisory in March 2005 advising physicians about a potential cancer risk. A definitive causal link between the eczema drugs and cancer has not been established, although rare reports of skin cancer and lymphoma.
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