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September 2006

Topical Calcineurin Inhibitors Labeling: Putting the “Box” in Perspective

Arch Dermatol. 2006;142(9):1231-1244. doi:10.1001/archderm.142.9.1233

In their editorial “Topical Calcineurin Inhibitors for Atopic Dermatitis: Balancing Clinical Benefit and Possible Risks,” Qureshi and Fischer1 pay little attention to the events spanning nearly 5 years that influenced the 2005 actions of the US Food and Drug Administration (FDA) Advisory Committee [hereafter referred to as the Committee] that recommended labeling changes for pimecrolimus cream (Elidel; Novartis Pharmaceuticals Corp, East Hanover, NJ) and tacrolimus ointment (Protopic; Astellas Pharma US Inc, Deerfield, Ill).1 Understanding this history is essential for judging the reasonableness of the Committee's recommendation that a black box warning for pimecrolimus and tacrolimus be added to these products' labeling. Among the facts that deserve special consideration are those reflected in the deliberations of 2 prior Committee the extent and nature of off-label use and direct-to-consumer product advertising for these products, particularly topical pimecrolimus, and a systematic review of the efficacy of these medications.24 I believe that an unbiased review of these facts supports the Committee's 2005 recommendations and the 2006 label changes59 (Figure), including the boxed warning and medication guides, will help improve the care of our patients.