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U.S. Department of Health and Human Services
National Pharmacy & Therapeutics Committee

FDA updating warnings to improve safe use of prescription stimulants used to treat ADHD and other conditions

The U.S. Food and Drug Administration (FDA) released a drug safety communication 1 to address continuing concerns of misuse, abuse, addiction, and overdose of prescription stimulants. The FDA is requiring updates to the Boxed Warning and other information to ensure the prescribing information is made consistent across the entire class of these medicines.

Updated Boxed Warning information will:

  • describe the risks of misuse, abuse, addiction, and overdose consistently across all medicines in the class.
  • advise heath care professionals to monitor patients closely for signs and symptoms of misuse, abuse, and addiction.

    • Recommendations for Healthcare Providers

    • Assess patient risk of misuse, abuse, and addiction before prescribing stimulant medicines.
    • Be aware that most individuals who misuse prescription stimulants get their drugs from other family members or peers.
    • Counsel patients not to give any of their medicine to anyone else and monitor for signs and symptoms of diversion such as requesting refills more frequently than needed.
    • Throughout treatment with prescription stimulants, regularly assess and monitor for signs and symptoms of nonmedical use and addiction.
    • Keep careful records of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal laws.
    • Educate patients and caregivers on the importance of proper storage and disposal of prescription stimulants.
    • Advise patients and caregivers that taking a prescription stimulant other than how it is prescribed, or together with alcohol or other controlled substances, could increase the risk of overdose and death.
    • Inform patients and caregivers how to recognize the signs and symptoms of an overdose.
    • Encourage patients to read the Medication Guide they receive with their filled prescription(s). This important information will be included, as well as additional information about the medicine.

    To help FDA track safety issues with medicines, report adverse events involving prescription stimulants or other medicines, please report adverse events to the MedWatch program as recommended in the Indian Health Manual. Enter "IHS" in the reporter section of the form. Instructions for reporting can be found online at the NPTC Pharmacovigilance website

    1 Food and Drug Administration. (2023, May,11). FDA updating warnings to improve safe use of prescription stimulants used to treat ADHD and other conditions. Link