ROCKVILLE, Md., Jan. 20 - 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. Reported cancers among Elidel and Protopic users, which the FDA characterized as rare, included skin cancers and lymphoma.
The black-box warning emphasized that the long-term safety of the two drugs has not been established. It recommended that the drugs be considered second-line therapy, used for short-term treatment in patients who have not responded to other treatments. If short term treatment is not effective, the FDA said a second course of Elidel or Protopic treatment can be initiated "after a period of time off treatment."
"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. "While Novartis believes this action is not substantiated by scientific or clinical evidence, Novartis has agreed to make the requested changes," the statement said.
A statement issued by Astellas said Protopic is safe and effective when used "in a manner consistent with its label."
The companies estimated that 10 million people have used the drugs.