Black Box Warning
Boxed warnings (formerly known as Black Box Warnings) are the highest safety-related warning that medications can have assigned by the Food and Drug Administration. These warnings are intended to bring the consumer’s attention to the major risks of the drug. Medications can have a boxed warning added, taken away, or updated throughout their tenure on the market. Over 400 different medications currently have boxed warnings.
Delong C, Preuss CV. Black Box Warning. [Updated 2023 Feb 11]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-.