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.

Примеры

  • 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.