Boxed warning
The strongest FDA warning, displayed in a black border at the top of a drug label.
Definition
A boxed warning (informally "black box warning") is the FDA's most stringent label warning. It appears as a bordered block at the top of the prescribing information for drugs with serious or life-threatening risks (e.g. suicidality with antidepressants, cardiovascular events with thiazolidinediones, infection with TNF inhibitors).
See also
- Adverse event — Any untoward medical occurrence in a patient receiving a drug, regardless of causality.
- REMS — An FDA-required safety plan for drugs with significant risks (e.g. teratogenicity, addiction).