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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 . . . [Full Text of this Article]

AUTHOR INFORMATION
Robert S. Stern, MD

RELATED LETTERS

Topical Calcineurin Inhibitors Revisited
Abrar Qureshi and Michael A. Fischer
Arch Dermatol. 2007;143(4):545-546.
EXTRACT | FULL TEXT  

National Eczema Association and Topical Calcineurin Inhibitor Labeling
Kevin Cooper
Arch Dermatol. 2007;143(4):546.
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RELATED ARTICLE

Topical Calcineurin Inhibitors for Atopic Dermatitis: Balancing Clinical Benefit and Possible Risks
Abrar A. Qureshi and Michael A. Fischer
Arch Dermatol. 2006;142(5):633-637.
EXTRACT | FULL TEXT  

THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Topical Calcineurin Inhibitors Revisited
Qureshi and Fischer
Arch Dermatol 2007;143:545-546.
FULL TEXT  

National Eczema Association and Topical Calcineurin Inhibitor Labeling
Cooper
Arch Dermatol 2007;143:546-546.
FULL TEXT