Abstract
Pimecrolimus is a drug belonging to the class of macrolactamic immunosuppressants, similar to tacrolimus, and has been employed mainly in the treatment of atopic dermatitis, but is also active in other skin diseases, including genital lichen sclerosus (LS). The safety profile of pimecrolimus was the subject of special attention by the US FDA, which in 2005 issued a Public Health Advisory on the potential risk of cancer associated with the use of topical calcineurin inhibitors. However, many scientific societies have criticized the FDA note, referring to the vast literature on the subject in which there is no evidence available that topical use of the drug is dangerous. Patients with LS, of both sexes, may develop genital squamous cell carcinoma. This event, however, is not a contraindication to the use of pimecrolimus.
Financial & competing interests disclosure
The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
No writing assistance was utilized in the production of this manuscript.
Key issues
• Genital lichen sclerosus is usually treated with ultra-potent topical corticosteroids.
• The prolonged use of ultra-potent corticosteroids can cause dermal atrophy.
• Calcineurin inhibitors, in particular pimecrolimus, have been proposed as second-line drugs.