Tacrolimus ointment for the treatment of adult and pediatric atopic dermatitis: Review on safety and benefits

Atopic dermatitis (AD) requires long‐term management, mainly with topical anti‐inflammatory agents. Topical corticosteroids (TCS) and tacrolimus ointment (TAC‐O) are recommended as first‐line treatments for AD. However, the long‐term use of TCS is limited by cutaneous adverse events such as skin atrophy. For TAC‐O, Japanese and US labelings were updated in 2003 and 2006, respectively, to include a boxed warning about a theoretical risk of skin cancer and lymphoma in patients treated with topical calcineurin inhibitors. However, TAC‐O has been used worldwide for longer than 15 years to treat adult and pediatric patients with AD. Available data suggest that TAC‐O is effective and well tolerated, and can improve quality of life. TAC‐O has successfully been used in the proactive management of AD consisting of long‐term intermittent use to prevent, delay or reduce the occurrence of AD flares. Systemic drug absorption after TAC‐O application is negligible and unlikely to result in systemic immunosuppression. There is currently no strong evidence of an increased rate of malignancy in treated patients, and observational data from postmarketing surveillance studies have shown no safety concerns. In the absence of robust evidence, the warning about the carcinogenic potential in the Japanese labeling for TAC‐O does not appear justified and should be reconsidered. This mitigation of description would allow adult and pediatric patients with AD to receive the effective treatment more appropriately.