Black Box Warning

Views Updated: Dec 15, 2025

Abbreviation

BBW

Pronunciation

/blæk bɑks ˈwɔrnɪŋ/

In2006, the warning was upgraded to a black box warning, the FDA's strongest form of warning, because of new data concerning risks of heart valve damage.
The agency had first slapped a so-called black box warning, the toughest kind, on the drugs in March as an interim measure.
Some urged a " black box " warning on Avandia, the strongest type of warning for prescription drugs.
Actos carries a " black box " warning that the drug may trigger heart failure, but it has not been linked to any increased risk of heart attack.
Afterwards, he said that the FDA needs to hae a " black box " warning about heart attack risk, not just heart failure risk, which he said has been known for a long time.

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