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FDA Talk Paper

March 10, 2005

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FDA Issues Public Health Advisory Informing Health Care Providers of Safety Concerns Associated with the Use of Two Eczema Drugs, Elidel and Protopic

The Food and Drug Administration (FDA) today advised health care professionals to prescribe Elidel (pimecrolimus) and Protopic (tacrolimus) only as directed and only after other eczema treatments have failed to work because of a potential cancer risk associated with their use. In addition, FDA is adding a black box warning to the health professional label for the two products and developing a Medication Guide for patients.

Today’s actions follow the recommendations made by the FDA’s Pediatric Advisory Committee during its February 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 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. 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:

Protopic was approved in 2000 and Elidel in 2001 to treat eczema.


Elidel (pimecrolimus) Cream and Protopic (tacrolimus) Ointment - (March 10, 2005)
Tacrolimus (marketed as Protopic Ointment) Information - FDA Alert 3/2005
Pimecrolimus (marketed as Elidel Cream) Information - FDA Alert 3/2005


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