This Article  • Full text  • PDF  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citation map  • Contact me when this article is cited  Related Content  • Similar articles in this journal  Topic Collections  • Drug Therapy, Other  • Dermatologic Disorders, Other  • Drug Therapy  • Alert me on articles by topic

Abrar Qureshi, MD, MPH; Michael A. Fischer, MD, MS

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

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.

Stern¹ appears to believe that we have singled out the FDA for criticism. While we did argue that the FDA process is flawed, the . . . [Full Text of this Article]

AUTHOR INFORMATION