NEW YORK (Reuters Health) - Topical pimecrolimus as a treatment for eczema may have no significant cancer risk, contrary to a U.S Food and Drug Administration warning, according to new research published online February 18 in JAMA Dermatology.
"At this time the clinical evidence does not seem to support the potential safety concerns," Dr. David Margolis, a professor of dermatology at the University of Pennsylvania in Philadelphia, who led the study, told Reuters Health by email.
"When pimecrolimus was first released it was a member of a new class of topical treatments. There was concern about its safety, not because of clinical trial information but because of potential effects of the molecule itself," Dr. Margolis says.
Pimecrolimus, a calcineurin inhibitor, is one of only a few topical treatments approved for eczema in children, and the FDA has issued a warning that it may have a cancer risk. The warning stems from oral and topical doses in animal studies and case reports in people. As such, the FDA limits the topical agent to a second-line treatment.
Dr. Margolis and colleagues evaluated a 10-year span of data from nearly 7500 children enrolled in PEER, an ongoing long-term study of children with eczema.
In nearly 27,000 person-years, the patients developed five malignancies, none of which was skin cancer. The standardized incidence ratio was not statistically different from that of a general population database at the National Cancer Institute.
In light of these findings, the regulatory warning may have had the unintended effect of harming patients who needed treatment, Dr. Jon Hanifin, a dermatologist at Oregon Health and Science University in Portland, Oregon, told Reuters Health by email.
"Atopic dermatitis is a disease that causes discomfort, sleep loss and anxiety but those problems tend to be ignored by many doctors and by the FDA. These patients need help and the FDA and their medical consultants have been slow to deal with the problem," Dr. Hanifin says.
This new research may improve treatment, Dr. Hanifin says in an accompanying editorial in the same journal.
Professional associations including the American Academy of Dermatology and the National Eczema Association are urging the FDA to speed the approval of new drugs for children, Dr. Hanifin says.
Valeant Pharmaceuticals International, the manufacturer of Elidel, which is the brand name of topical pimecrolimus, funded this study through a grant to the Trustees of the University of Pennsylvania. Dr. Margolis reports serving on a data safety monitoring board for an Astellas Pharma atopic dermatitis study. SOURCE: https://bit.ly/1wdzd17 and https://bit.ly/1zeWlwv JAMA Dermatol 2015.
Reuters Health Information © 2015