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U.S. Department of Health and Human Services

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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

T05-06
March 10, 2005

Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA

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:

  • 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.

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

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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