Protopic and Elidel, two treatments for eczema approved in 2000 and 2001, have now been found to cause cancer in three different animal species.
The Food and Drug Administration (FDA) has advised health care professionals to prescribe Elidel (pimecrominum) and Protopic (tacrolimus) only as directed and only after other eczema treatments have failed to work because this potential cancer risk associated with their use. It is also adding a black box warning to the health professional label for the products and developing a Medication Guide for patients.
The actions follow the recommendations made by the FDA’s Pediatric Advisory Committee during its meeting last month (Feb 2005). Cancer was found in animal species and 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 will 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, but do so 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: