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.
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| http://dx.doi.org/10.2165/00128071-200708040-00001 | DOI Listing |
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Background: Atopic dermatitis (AD) is a chronic inflammatory skin disorder characterized by itching and redness, affecting individuals of all ages and significantly impairing their quality of life. The prevalence of AD is rising, posing serious health concern. Relief of itching is a primary treatment objective; however, steroid treatments can lead to adverse effects, including skin barrier thinning.
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