Black Box Warning (BBW)

BBW

Regulatory

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.

Exemples

Fluoroquinolones: tendon rupture
SSRIs: suicidality in youth
Thiazolidinediones: heart failure

Le saviez-vous ?

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.