What is a black box warning?

• A. A warning indicating low medication stock
• B. A strict warning prescribed by the FDA to indicate serious side effects
• C. A warning regarding medication pricing
• D. A label for over-the-counter medications

Answer: (B)

A black box warning is a strict warning mandated by the Food and Drug Administration (FDA) that highlights significant risks associated with a particular medication. This warning is the most serious type of warning and is typically displayed in a prominent box on the medication's label or packaging. The black box warning informs healthcare providers and patients about potentially life-threatening side effects, interaction risks, or conditions that require careful monitoring during treatment. The intention is to ensure that both patients and providers are fully aware of the serious risks involved, enabling informed decision-making regarding the use of the medication.

The other options do not accurately describe what a black box warning entails. Medication stock levels, pricing, and over-the-counter labels do not relate to the serious safety concerns that black box warnings address.