Safety Concerns for Two Eczema Drugs

In March 2005, the FDA issued a public health advisory about the potential cancer risk associated with Elidel (pimecrolimus) and Protopic (tacrolimus). Both products are applied to the skin to control eczema by suppressing the immune system.

The FDA advised health care professionals to prescribe Elidel and Protopic only as directed and only after other eczema treatments have failed. The agency is also adding a "black box" warning to the professional labeling for the products and is developing a medication guide for patients.

These actions follow recommendations made by the FDA's Pediatric Advisory Committee during its Feb. 15, 2005, meeting. At this meeting, findings of cancer in three different animal species were reviewed. The 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 Elidel or Protopic.

The manufacturers of the products have agreed to conduct research on whether there is an actual risk of cancer in humans. The FDA advises physicians to weigh the risks and benefits of these drugs and to consider the following about Elidel and Protopic:

• They are approved for short-term and intermittent treatment of eczema in people who are unresponsive to or intolerant of other treatments.

• They should be used only for short periods of time, not continuously. The long-term safety of these products is unknown.

• They are not approved for use in children younger than 2 years old.

• Children and adults with a weakened or compromised immune system should not use these products.

• The minimum amount needed to control the patient's symptoms should he used. The animal data suggest that the risk of cancer increases with increased exposure.

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