What are the safety profiles of topical calcineurin inhibitors for the treatment of pediatric atopic dermatitis (AD)?

Updated: Apr 26, 2021
  • Author: Robert A Schwartz, MD, MPH; Chief Editor: Dirk M Elston, MD  more...
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In January 2006, the Food and Drug Administration (FDA) approved a black box warning for tacrolimus and pimecrolimus topical medications. The warning emphasized the lack of long-term safety data and a possible link to malignancies. No causal link between these agents and the development of malignancies has been established. Long-term studies on the safety of these agents in humans are not yet available, and the black box warning was based on case reports in humans and on animal studies. An analysis of tacrolimus ointment use in patients with atopic dermatitis over 4 years did not show any increased risk of infections or cancer. [60] However, longer term studies (10 y of follow-up or longer) are needed before firm conclusions about these concerns can be reached. The safety of pimecrolimus has been stressed; labeling restrictions may be unnecessary. [57]

Establishing the long-term safety profile of topical calcineurin inhibitors is of paramount importance because they appear to provide an effective alternative to topical corticosteroid treatment in certain patients. Furthermore, pimecrolimus has been shown to improve the epidermal skin barrier without the concurrent risk of local skin atrophy commonly seen with topical corticosteroid treatment. [61] Thus, pimecrolimus appears to be an attractive candidate for long-term use in either a therapeutic or preventative capacity.

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