Alan B Fleischer1. 1. Department of Dermatology, Wake Forest University School of Medicine, Winston-Salem, NC, USA. afleisch@wfubmc.edu
Abstract
OBJECTIVE: This commentary is designed to provide a clinical viewpoint regarding the Food and Drug Administration (FDA) and its recent decision to imposed a "black box warning" on the topical calcineurin inhibitors, pimecrolimus and tacrolimus. DESIGN: Select references were used to review the relevant data. RESULTS: Although there is a theoretic risk of oncogenesis because of the trivial systemic absorption of these agents and there exist anecdotes of cancer occurring amongst the millions of people who have used these agents, human data from randomized controlled trials suggest a protective effect from cancer. Although results from randomized controlled trials provide the highest level of evidence, the FDA chose to warn the public on the basis of weak and likely faulty data. Subsequent to the FDA actions, utilization of the best-studied class of agents for atopic dermatitis has fallen significantly. CONCLUSIONS: These actions represent a "death of common sense" and have profound impact both on our ability to safely and effectively care for patients and our medicolegal risk.
OBJECTIVE: This commentary is designed to provide a clinical viewpoint regarding the Food and Drug Administration (FDA) and its recent decision to imposed a "black box warning" on the topical calcineurin inhibitors, pimecrolimus and tacrolimus. DESIGN: Select references were used to review the relevant data. RESULTS: Although there is a theoretic risk of oncogenesis because of the trivial systemic absorption of these agents and there exist anecdotes of cancer occurring amongst the millions of people who have used these agents, human data from randomized controlled trials suggest a protective effect from cancer. Although results from randomized controlled trials provide the highest level of evidence, the FDA chose to warn the public on the basis of weak and likely faulty data. Subsequent to the FDA actions, utilization of the best-studied class of agents for atopic dermatitis has fallen significantly. CONCLUSIONS: These actions represent a "death of common sense" and have profound impact both on our ability to safely and effectively care for patients and our medicolegal risk.