title: Cancer concerns with topical immunomodulators in atopic dermatitis: overview of data and recommendations to clinicians.
abstract: The topical immunomodulators tacrolimus and pimecrolimus were approved for the treatment of atopic dermatitis in 2000 and 2001, respectively. However, on 20 January 2006, the US FDA approved a 'black box' warning for these agents because of concerns regarding a possible link to development of malignancy. These concerns were based upon the known mechanism of action of this drug class, the results of animal studies, and case reports. This article provides an overview of the data that led to the approval by the FDA of a 'black box' warning and concludes that physicians, patients, and caregivers should feel confident about using tacrolimus and pimecrolimus for atopic dermatitis so long as they follow the FDA guidelines.
authors.affiliation: Division of Dermatology, Department of Medicine, University of Tennessee, Memphis, Tennessee 38104, USA.
authors.forename: Tejesh S
authors.initials: TS
authors.lastname: Patel
authors.forename: Sarah C
authors.initials: SC
authors.lastname: Greer
authors.forename: Robert B
authors.initials: RB
authors.lastname: Skinner
mesh_terms: D000287:Administration, Topical; D000818:Animals; D015197:Carcinogenicity Tests; D003876:Dermatitis, Atopic / Q000188:drug therapy* / Q000276:immunology; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects* / Q000627:therapeutic use; D008223:Lymphoma / Q000139:chemically induced*; D023421:Models, Animal; D012878:Skin Neoplasms / Q000139:chemically induced*; D016559:Tacrolimus / Q000009:adverse effects* / Q000031:analogs & derivatives* / Q000627:therapeutic use; D014466:Ultraviolet Rays / Q000009:adverse effects
chemical_list: D007166:Immunosuppressive Agents; C117268:pimecrolimus; D016559:Tacrolimus