black box warning
The FDA's strongest warning for prescription medications, highlighting serious or life-threatening risks.
Full Definition
A black box warning, also known as a boxed warning, is the most serious warning that the FDA can assign to a prescription medication. It appears in a black-bordered box at the top of the medication's prescribing information and alerts healthcare providers and patients to serious or potentially life-threatening risks. In psychopharmacology, notable black box warnings include increased suicidal thoughts in young adults taking antidepressants, increased mortality in elderly patients with dementia taking antipsychotics, and severe withdrawal symptoms with benzodiazepines. Despite these warnings, the benefits may still outweigh the risks when used appropriately.
Usage
Usage note: Hyphenated as 'black-box warning'; may also be written as 'boxed warning.'
In Context
- "The antidepressant carries a black box warning for increased suicidal ideation in adolescents." — medication safety review
- "Despite the black box warning, the medication was deemed appropriate with close monitoring." — risk-benefit analysis