FDA adds black box to eczema drug labels to warn public about cancer risks

• The FDA said black box warnings about the possible risks of skin cancer and lymphoma have been added to the labels of Elidel Cream (pimecrolimus) and Protopic Ointment (tacrolimus), two popular eczema drugs.
• Although no causal link between cancer and the two drugs has been established, the FDA said it has received reports of 78 cases of cancer among patients using the drugs.
• A year ago, the FDA's Pediatric Drugs Advisory Committee recommended that the drugs' labeling be updated with a boxed warning and a medication guide about the possible cancer risk for these drugs.
• A month later the FDA issued a Public Health Advisory advising physicians about the possible cancer risk.
• It recommended that the drugs be considered second-line therapy, used for short-term treatment in patients who have not responded to other treatments.
• "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 Steven Galson, M.D., director of FDA's Center for Drug Evaluation and Research.
• "Today's actions are aimed at making sure that health care providers and consumers understand the new warnings and that it is important that these products be used as recommended in the label."
• Elidel is made by Novartis Pharmaceuticals and Protopic is made by Astellas Pharma Inc. "Although studies are being conducted by the manufacturers of both drugs to try to answer questions about cancer risk, it could be many years before the research is concluded," the FDA said.
• A statement issued by Novartis said the company is confident that Elidel is safe.
• A statement issued by Astellas said Protopic is safe and effective when used "in a manner consistent with its label."