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March 11, 2015
New Study: Pimecrolimus Use Not Linked to
Cancer in Children Philadelphia—Based on pimecrolimus use in a group of children followed for a decade, it appears unlikely that the topical medicine is associated with increased of risk of cancer, according to a new study. The research should ease concerns about using the topical cream to treat atopic dermatitis (AD), which occurs most frequently in the first decade of life, according to the article appearing in JAMA Dermatology. In 2001, the FDA and the European Union Medicines Agency approved pimecrolimus, marketed as Elidel Cream, to treat eczema in children at least 2 years old. Two years later, the FDA issued a public health advisory on potential cancer risk from use of two topical calcineurin inhibitors (TCIs)—Elidel and Protopic (tacrolimus)—and added a black box warning to the labels. “This concern is based on information from animal studies, case reports in a small number of patients, and how these drugs work,” the FDA said at the time, noting that it could take more than a decade to determine whether the drugs were linked with cancer. In the meantime, it advised that the topical treatments only should be used in patients where other therapies had failed. The new study notes that oral calcineurin inhibitors originally were approved as immunosuppressive treatments for patients after solid organ transplant to prevent rejection and had been associated with an increased risk of cancer, especially skin cancer and lymphoma. The Pediatric Eczema Elective Registry (PEER) study began in 2004 as part of the postmarketing commitments for the approval of pimecrolimus, according to the report. For the study, David J. Margolis, MD, PhD, of the University of Pennsylvania and coauthors analyzed data through May 2014 to evaluate the risk of cancer by comparing expected rates from the Surveillance, Epidemiology and End Results (SEER) program. More than 7,400 children representing greater than 26,000 person-years participated in the PEER investigation; participants used an average of 793 grams of pimecrolimus during the study period. As of May 2014, two leukemias, one osteosarcoma, and two lymphomas were reported in the group, but no skin cancers. The authors note that none of the findings regarding incidence of the disease were statistically significant. “Based on more than 25,000 person-years of follow-up, it seems unlikely that topical pimecrolimus as it was generally used in the PEER cohort to treat AD is associated with an increased risk of malignancy,” the study concludes. In a related editorial, Jon M. Hanifin, MD, of Oregon Health and Science University, Portland, writes that the study “will hopefully help to improve the management of AD, countering the concerns raised by FDA warnings.” Hanifin added that the “optimistic” report “should help reduce the physician and pharmacist concerns that have restricted the use of these effective topical alternatives to corticosteroids. The interim results should help bring relief to a larger segment of the many young individuals with AD.” |
U.S. Pharmacist Social Connect
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