title: The Value of the Black Box Warning in Dermatology.
abstract: Boxed, or "black box" warnings are issued by the United States Food and Drug Administration (US FDA) as a means to label drugs associated with serious adverse events. However, there is no clear metric to determine how and when the boxed warning is applied. Inconsistencies in the review process, language, timing, and dissemination of these warnings impact dermatologists and their patients. Appropriate patient selection and monitoring can help minimize risk to patients when prescribing drugs with boxed warnings. Future changes in the manner in which the boxed warning is issued and in its subsequent clinical application may improve the utility of these warnings for dermatologists and ultimately, patient safety.
authors.forename: Laura
authors.initials: L
authors.lastname: Winterfield
authors.forename: Ruth Ann
authors.initials: RA
authors.lastname: Vleugels
authors.forename: Kelly K
authors.initials: KK
authors.lastname: Park
mesh_terms: D003879:Dermatologic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D003880:Dermatology; D004348:Drug Labeling; D006801:Humans; D061214:Patient Safety; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D003879:Dermatologic Agents