boxed warning (black box warning)
the FDA's strongest label warning — text in a black border at the top of a drug's prescribing information, reserved for risks that are serious or life-threatening.
every antidepressant in the US carries one. here is what the black box actually is, what it is not, and the rare case where one was removed.
what it is
A boxed warning is the strongest warning the FDA puts on a prescription drug label: a paragraph set in a black border at the very top of the prescribing information, reserved for adverse reactions that can cause serious injury or death, or serious risks that prescribing decisions can reduce. Every antidepressant sold in the US carries the same class-wide boxed warning, added in 2004 and extended in 2007: increased risk of suicidal thoughts and behavior in children, adolescents and young adults in short-term studies. That is a statement about trial statistics in specific age groups — not a prediction about any individual, and not a statement that the drugs do not work.
warnings can also be removed
In 2016, after the FDA-required EAGLES trial came back reassuring, the agency removed the serious-neuropsychiatric-events language from the boxed warning of the smoking-cessation form of bupropion. The warning system runs in both directions — added by signals, retired by evidence — and a library that only showed you one direction would be selling something.
somewhere to put it
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questions
does a boxed warning mean I shouldn't take the drug?
No — it means the FDA decided this specific risk deserves the top of the label. It is the first thing to read and the first thing to ask your prescriber about, not a prohibition.
do all antidepressants have a black box warning?
Yes — the same class-wide suicidality warning covering children, adolescents and young adults, ordered in 2004 and extended to under-25s in 2007.
more from the glossary
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