The Food and Drug Administration on Thursday issued a warning that two prescription skin medications could pose long-term cancer risks.
The agency said it approved "black box" warnings, its strongest alert, for the labels of Elidel, made by Switzerland's
, and Protopic, made by Japan's
. Astellas was formerly known as Fujisawa Pharmaceutical.
The FDA's action follows up a public health advisory that
it issued last March. The notice alerted patients and physicians to possible side effects from these drugs that treat eczema, which causes dry, red scaly skin. The FDA says eczema, or atopic dermatitis, is a common skin disorder among infants and children, affecting 10% to 15% of them.
"The new labeling also clarifies that these drugs are recommended for use as second-line treatments," the FDA said. "This means that other prescription topical medicines should be tried first. Use of these drugs in children under 2 years of age is not recommended."
Last February, an FDA advisory committee recommended that the drugs labels carry a black box warning.
"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 Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research.
"While Novartis believes this action is not substantiated by scientific or clinical evidence, Novartis has agreed to make the requested changes and will communicate them to physicians and patients," said Tom Jones, a company spokesman. "Clinical studies in more than 21,000 patients, including 3,500 infants and 7,500 children, and experience in more than 6 million patients worldwide, show that Elidel has a favorable safety profile and is not associated with an increased risk of malignancy."
After the FDA issued its public health advisory last March, Novartis complained that the FDA was reacting to animal studies rather than human studies.
"The clinical data in humans do not show any evidence of an increased risk of cancer," says the company's website. "The public health advisory referred to animal studies designed to look for cancer formation."
Novartis says that in one study, "animals swallowed very high doses of an experimental form of the drug -- not the cream form applied to the skin -- over a long period of time. Some of the animals developed lymphomas, but the drug levels in these animals are not reached using Elidel cream applied to the skin."
The FDA conceded that "a causal link has not been established" between the drugs and cancer in humans. However, "rare reports of cancer -- for example, skin
cancer and lymphoma -- have been reported in patients who had been receiving these products," the agency said. "The boxed warning informs health-care professionals that the long-term safety of these drugs has not been established."
The agency said both companies are conducting studies about their drugs and the risk of cancer, but added that it could be many years before the research is completed.