The Value of the Black Box Warning in Dermatology

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.