U.S. FDA warnings derived from oral use appear to not apply to topical use.
Two calcineurin inhibitors are used topically to treat atopic dermatitis — tacrolimus (Protopic and generics) and pimecrolimus (Elidel and generics). Because the oral calcineurin inhibitors cyclosporine and tacrolimus are associated with excess risk for skin cancers and lymphomas, the FDA has warned about potential risk for nonmelanoma skin cancers with use of topical calcineurin inhibitors. This perceived risk was assessed in a retrospective cohort study (from a California healthcare system) that involved ≈94,000 adults (mean age, 59) with diagnoses of atopic dermatitis. Patients were exposed to a topical calcineurin inhibitor alone, a topical corticosteroid alone, both medications, or no treatment. Mean follow-up was ≈8 years.
In analyses …
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