The FDA issued a public health advisory about a potential cancer risk from the use of pimecrolimus (Elidel) and tacrolimus (Protopic). The agency stated that the two drugs should be used only as directed and only after other eczema treatments have failed because of a potential cancer risk associated with their use. Additionally, black box warnings have been added to the labeling of the two products; a medication guide is being designed for patients.

The advisory was issued in response to recommendations made by the FDA's Pediatric Advisory Committee because of cancer found in three different animal species. Data showed that the risk of cancer increased as the amount of the drug given increased. The data also included a small number of reports of cancers in children and adults treated with pimecrolimus and tacrolimus.

The manufacturers of pimecrolimus and tacrolimus will be conducting research to determine whether there is an actual risk of cancer in humans, and, if so, to what extent.

The FDA advised healthcare providers to weigh the risk and benefits of these drugs and to use these drugs as second-line agents for short-term and intermittent treatment of eczema in patients unresponsive to or intolerant of other treatments. Avoid use of these medications in children younger than 2 years of age.