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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.

Result(s) (1)
Attention Deficit Hyperactivity Disorder (ADHD) Medications and Heart Failure
Related Publication(s) and/or Presentation(s) (2)
Presentation: Sentinel Initiative Public Workshop - Ninth Annual Publication: Incidence of Heart Failure and Cardiomyopathy Following Initiation of Medications for Attention-Deficit/Hyperactivity Disorder: A Descriptive Study