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April 2007

Topical Calcineurin Inhibitors Revisited

Arch Dermatol. 2007;143(4):543-551. doi:10.1001/archderm.143.4.545

In his letter “Topical Calcineurin Inhibitors Labeling: Putting the ‘Box’ in Perspective,”1 Stern provides a historical perspective on the process that led the US Food and Drug Administration (FDA) to place a black-box warning on topical tacrolimus and pimecrolimus. In his defense of the FDA's decision to warn prescribers that topical calcineurin inhibitors (TCIs) may be associated with cancer, however, he misunderstood the thrust of our editorial2 and seems to question our motives. The issues involved are well summarized by the Institute of Medicine's recent report on the future of drug safety.3 The report finds substantial problems in defining drug risks throughout the drug-approval and postmarketing surveillance processes and calls for major changes in the current system.