FDA: Elidel and Protopic should be used only for short periods of time, not continuously. The long term safety of these products is unknown.

The agency is telling physicians to prescribe the medications only as directed and only after other treatments have failed to work. The FDA also is adding a black box warning to the health professional label for the two products.

Some Cancers in Humans

Findings of cancer in three different animal species were reviewed during the FDA's Pediatric Advisory Committee on February 15, 2005, The data showed that the risk of cancer increased as more of the drug was given.

The data included a small number of reports of cancers in children and adults treated with Elidel or Protopic.

The manufacturers of the products have agreed to conduct research to determine whether there is an actual risk of cancer in humans, and, if so, its extent. Both products are applied to the skin to control eczema by suppressing the immune system.

Physicians Should Weigh Risks

FDA's Public Health Advisory specifically advises physicians to weigh the risks and benefits of these drugs in adults and children and consider the following:

• Elidel and Protopic are approved for short-term and intermittent treatment of atopic dermatitis (eczema) in patients unresponsive to, or intolerant of other treatments.

• Elidel and Protopic are not approved for use in children younger than 2 years old. The long-term effect of Elidel and Protopic on the developing immune system in infants and children is not known. In clinical trials, infants and children younger than 2 years of age treated with Elidel had a higher rate of upper respiratory infections than those treated with placebo cream.

• Elidel and Protopic should be used only for short periods of time, not continuously. The long term safety of these products is unknown. Children and adults with a weakened or compromised immune system should not use Elidel or Protopic.

• Use the minimum amount of Elidel and Protopic needed to control the patient's symptoms. The animal data suggest that the risk of cancer increases with increased exposure to Elidel or Protopic.