The Food and Drug Administration (FDA) is requiring updated warnings for prescription stimulants to ensure the safe use of these medications.
Specifically, the Boxed Warning in the prescribing information for the entire class of prescription stimulants will be updated to describe the risks of misuse, abuse, addiction, and overdose. Other sections of the labeling will also be significantly changed to ensure consistent messaging regarding these serious risks. To address these concerns, health care providers are being advised to counsel patients not to share their medications; education on proper storage and disposal is also being encouraged.
The requested updates to the labeling were made based on a review of medical literature (between January 2006 and May 2020) that showed family members and friends were the most common source of prescription stimulants for nonmedical use. These shared medications were most commonly used by individuals 18 to 25 years of age. According to the literature, use of prescription stimulants by individuals who were not prescribed these medications has been associated with a higher risk of developing substance use disorder and addiction.
While being treated with prescription stimulants, health care providers should regularly assess and monitor for the signs and symptoms of nonmedical use and addiction. In addition, careful records should be kept that indicate the quantity, frequency, and renewal requests for these medications.
Adverse events involving prescription stimulants should be reported to the FDA’s MedWatch Program.
Food and Drug Administration. FDA updating warnings to improve safe use of prescription stimulants used to treat ADHD and other conditions. May 11, 2023. Accessed May 15, 2023. https://www.fda.gov/drugs/drug-safety-and-availability/fda-updating-warnings-improve-safe-use-prescription-stimulants-used-treat-adhd-and-other-conditions.