Black box warning for topical calcineurin inhibitors and the death of common sense.
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.


METHODS
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.
Fleischer
Alan B
AB
Department of Dermatology, Wake Forest University School of Medicine, Winston-Salem, NC, USA. afleisch@wfubmc.edu
D000287:Administration, Topical; D065095:Calcineurin Inhibitors; D000075202:Contraindications; D004348:Drug Labeling; D017007:Duty to Warn; D019317:Evidence-Based Medicine; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000009:adverse effects*; D009369:Neoplasms / Q000139:chemically induced / Q000517:prevention & control; D016032:Randomized Controlled Trials as Topic; D012306:Risk; D016559:Tacrolimus / Q000008:administration & dosage / Q000009:adverse effects* / Q000031:analogs & derivatives*; D014481:United States; D014486:United States Food and Drug Administration
D065095:Calcineurin Inhibitors; D007166:Immunosuppressive Agents; C117268:pimecrolimus; D016559:Tacrolimus