Medications for Attention Deficit Hyperactivity Disorder & Cardiomyopathy and Heart Failure

    Basic Details
    Status
    Complete
    Last Updated
    Wednesday, December 29, 2021
    Original Posting Date
    Health Outcome(s)
    heart failure or cardiomyopathy
    Purpose
    Drug and Outcome Analysis
    Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
    No
    Regulatory Determination / Use

    Follow up investigation of case reports of cardiac events after long term stimulant use. FDA decided that no action is necessary at this time, based on available information.