Black Box Warning

A Black Box Warning is a prominent warning label on a medication’s packaging that highlights serious or potentially life-threatening risks associated with its use. It is designed to alert healthcare providers and patients about significant safety concerns, such as serious side effects or risks of harm. This warning is the most serious at the FDA’s disposal, signaling that the medication should be used with caution, only when necessary, and under close supervision. Its purpose is to ensure informed decision-making and to prioritize patient safety by clearly communicating potential hazards.