United States of America - The Food and Drug Administration (FDA) has advised health care professionals to prescribe pimecrolimus (Elidel®) and tacrolimus (Protopic®) 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.
This action follows recommendations made by the FDA’s Pediatric Advisory Committee during its 15 February 2005 meeting, at which findings of cancer in three different animal species were reviewed. The data showed that the risk of cancer increased in line with the amount of drug increase. The data also included a small number of reports of cancers in children and adults treated with pimecrolimus and tacrolimus.
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:
“Pimecrolimus and tacrolimus are approved for short-term and intermittent treatment of atopic dermatitis (eczema) in patients unresponsive to, or intolerant of other treatments. They are not approved for use in children younger than 2 years old. The long-term effect of pimecrolimus and tacrolimus 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 pimecrolimus had a higher rate of upper respiratory infections than those treated with placebo cream.”
Pimecrolimus and tacrolimus 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 pimecrolimus or tacrolimus.
Reference: FDA Talk Paper T05-06, 10 March 2005. http://www.fda.gov/medwatch