Black Box Warning (BBW)
BBWThe FDA's most serious warning placed on a drug's prescribing information, enclosed in a black border. Indicates life-threatening or serious risks requiring careful benefit-risk assessment.
ตัวอย่าง
- Fluoroquinolones: tendon rupture
- SSRIs: suicidality in youth
- Thiazolidinediones: heart failure
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The FDA's most serious warning placed on a drug's prescribing information, enclosed in a black border. Indicates life-threatening or serious risks requiring careful benefit-risk assessment.