FRIDAY, Jan. 20 (HealthDay News) -- The U.S. Food and Drug Administration has announced new labeling changes for two topical eczema drugs, Elidel Cream (pimecrolimus) and Protopic Ointment (tacrolimus), which will include a boxed warning about a possible cancer risk. There have been rare reports of skin cancers and lymphomas in patients taking these drugs, although no causal link has been established.
Pharmacists will also be required to provide patients with a Medication Guide, which provides information on how to safely use the drugs. The new labeling emphasizes that the drugs are meant to be used as second-line treatments and are not recommended for children under the age of 2 years. The boxed warning notes that although the long-term safety of these drugs has also not been established, the drugs may be beneficial when used appropriately and are intended to be used for short periods.
The updated labeling is based on recommendations made on Feb. 15, 2005 by the FDA's Pediatric Advisory Committee, which was followed by a Public Health Advisory to physicians in March 2005 about possible cancer risks.
"We are taking steps to ensure that health care providers and patients are aware of the possible long-term risks of these products so that they will be used appropriately," said Steven Galson, M.D., director of FDA's Center for Drug Evaluation and Research, in an FDA statement.
Novartis manufactures Elidel Cream, and Astellas Pharma, Inc. (formerly Fujisawa Healthcare) manufactures Protopic Ointment.
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