FDA required class-wide boxed-warning language addressing misuse, abuse, addiction, and overdose for prescription stimulants. The communication also required related updates elsewhere in prescribing information.
We are requiring that the Boxed Warning information, our most prominent warning, describe these risks consistently across all prescription stimulants, and we are requiring updates to other sections of the prescribing information.
FDA required class-wide boxed-warning language addressing misuse, abuse, addiction, and overdose for prescription stimulants. The communication also required related updates elsewhere in prescribing information.