Black Box Warning

BBW

Définition

The strongest safety warning issued by the FDA, appearing in a black-bordered box at the top of a drug's prescribing information. Black box warnings alert healthcare providers to serious or life-threatening risks associated with the medication.

Exemple

Fluoroquinolone antibiotics carry a black box warning for tendon rupture, peripheral neuropathy, and central nervous system effects.

Termes Associés

Adverse Drug Reaction ADR Drug Recall Pharmacovigilance PV

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