Data from RCTs do not suggest any serious adverse effects to date. Application reactions of burning, warmth, stinging and soreness have been consistently reported in the RCTs and are dose related. Systemic absorption does occur with pimecrolimus, but this is very small in the majority of people.9,10 No skin atrophy has been observed in a detailed study comparing topical pimecrolimus with 0-1% betamethasone valerate cream when applied to the forearms of healthy volunteers continuously for 4 weeks.11 Such a study is difficult to interpret however because potent topical steroids are not used in this way, and the effects of disease on skin thickness cannot be assessed.
As pimecrolimus is an immunosuppresive agent, theoretical long-term risk of cancer needs to be monitored, given that the drug is likely to be prescribed in large quantities to millions of children with mild forms of this common disease. In the Food and Drug Administration letter approving use of pimecrolimus in the US, reference is made to preclinical rodent studies that found an increased risk of lymphomas and follicular cell thyroid cancer in the studies evaluating oral formulations.2 Reference is also made to preclinical mouse photocarcinogenicity studies showing accelerated rates of skin cancers in such mice. Licensing was granted with requirement for further specific studies to assess such possible long-term risks.2
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