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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.2-4 I believe that an unbiased review of these facts supports the Committee's 2005 recommendations and the 2006 label changes5-9 (Figure), including the boxed warning and medication guides, will help improve the care of our patients.

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