The Value of the Black Box Warning in Dermatology

July 2015 | Volume 14 | Issue 7 | Editorials | 660 | Copyright © July 2015


Laura Winterfield MD MPH,a Ruth Ann Vleugels MD MPH,b and Kelly K. Park MD MSLa

aDivision of Dermatology, Loyola University Stritch School of Medicine, Maywood, IL
bDepartment of Dermatology, Brigham and Women's Hospital, Boston, MA

table 2
hepatotoxicity found that the labeling was highly variable and was affected by multiple factors, including recommendations made by different FDA drug review committees. In comparing drug labels with strategies for laboratory monitoring for hepatotoxicity, 12 different schedules were given for 15 drugs.23
Based on two national physician surveys, the FDA has recognized the need for revising the label format, and in June 2006 began a process to prioritize the positioning of information on the label. This includes placing the black box warning at the front of the prescribing information.24