To prevent misuse, abuse, and addiction of prescription stimulants, FDA is now requiring their boxed warning—the most prominent warning—to be updated. In addition, the agency is adding more to the prescribing information for all prescription stimulants.
FDA wants to make all prescribing information consistent across this entire class of medications.
“We are adding information that patients should never share their prescription stimulants with anyone, and the Boxed Warning information will describe the risks of misuse, abuse, addiction, and overdose consistently across all medicines in the class,” FDA said. “The Boxed Warning also will advise hea[l]th care professionals to monitor patients closely for signs and symptoms of misuse, abuse, and addiction.”
FDA said that information on these risks is now mandatory in several sections of the prescribing information, including the Warnings and Precautions, Drug Abuse and Dependence, Overdosage, and Patient Counseling sections.
FDA will also require updates to existing patient medication guides to help educate patients and caregivers about the risks of these medications.