The U.S. FDA ( Food and Drug Administration ) advised health care professionals to prescribe Elidel ( Pimecrolimus ) and Protopic ( Tacrolimus ) only as directed and only after other atopic dermatitis ( eczema ) treatments have failed to work because of a potential cancer risk associated with their use.

FDA’s decision was based on recommendations provided by FDA’s Pediatric Advisory Committee during its February 15, 2005 meeting.

At this meeting, the Committee members reviewed findings of cancer in three different animal species.
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.

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 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.

Source: FDA, 2005


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