TACROLIMUS OINTMENT SIDE EFFECTS

The carcinogenic potential of tacrolimus ointment beyond immune suppression: a hypothesis creating case report), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.Since tacrolimus ointment was approved by the U.S. Food and Drug Administration (FDA) as a promising treatment for atopic dermatitis, it has been approved in more than 30 additional countries, including numerous European Union member nations. Moreover, in the current clinical routine the use of this drug is no longer restricted to the approved indication, but has been extended to a wide variety of inflammatory skin diseases including some with the potential of malignant transformation. So far, the side-effects reported from the topical use of tacrolimus have been relatively minor (e.g. burning, pruritus, erythema). Recently, however, the FDA reviewed the safety of topical tacrolimus, which resulted in a warning that the use of calcineurin inhibitors may be associated with an increased risk of cancer.cells). Upon dephosphorylation, NFAT translocates to the nucleus, where it binds its nuclear counterpart to form an active transcription factor inducing the production of several cytokines mandatory for initiating an immune response. Hence, calcineurin inhibitors interfere with antigen specific T-cell activation. Furthermore, tacrolimus affects the function of mast cells, basophile leucocytes and Langerhans cells. These characteristics explain the great interest to apply tacrolimus topically on inflamed skin, particularly since it was the first new topical immune suppressant since the introduction of steroids. The first successful use of topical tacrolimus in patients with atopic dermatitis was reported by Nakagawa et al. in 1994 and already 6 years later the U.S. Food and Drug Administration (FDA) approved tacrolimus ointment as a promising treatment for atopic dermatitis [2,3].