Eczema drug Elidel may cause cancer
The Food and Drug Administration (FDA) today advised health care professionals to prescribe Elidel (pimecrolimus) 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 drug and developing a Medication Guide for patients. Elidel was approved in 2001 to treat eczema. Elidel cream and Protopic ointment are topical immunosuppressant calcineurin inhibitors that are applied to the skin and are the only approved drug products in this class. At this time, there is no mention of a recall of Elidel either by the FDA or Novartis. Protopic, another eczema drug, is also receiving a similar black box warning.
This FDA action follows 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.
The manufacturer of Elidel, Novartis, has agreed to conduct research to determine whether there is an actual risk of cancer in humans, and, if so, its extent. Elidel is 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 is approved for short-term and intermittent treatment of atopic dermatitis (eczema) in patients unresponsive to, or intolerant of other treatments.
- Elidel is not approved for use in children younger than 2 years old. The long-term effect of Elidel 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 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.
- Use the minimum amount of Elidel needed to control the patient’s symptoms. The animal data suggest that the risk of cancer increases with increased exposure to Elidel.
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