FDA Weighs in on ADHD Medications and Cardiovascular Risk

Caroline Cassels

December 12, 2011

December 12, 2011 — In light of two recent epidemiologic studies, the US Food and Drug Administration (FDA) is updating its communications with respect to medications for attention-deficit hyperactivity disorder (ADHD) on the ongoing cardiovascular safety review of medications used for treating ADHD.

The first study, published November 1 in the New England Journal of Medicine and reported by Medscape Medical News at that time, showed no increased risk for serious cardiovascular events, including sudden cardiac death, stroke, and myocardial infarction, among children and young adults.

In the second study, published online today in the Journal of the American Medical Association and also reported by Medscape Medical News, reported similar findings in young and middle-aged adults.

In a release, the FDA notes that recommendations for the use of medications to treat ADHD have not changed. The agency notes that healthcare professionals should take special note that:

  • Stimulant products and atomoxetine should generally not be used in patients with serious heart problems or in patients for whom an increase in blood pressure or heart rate would be problematic.

  • Patients treated with ADHD medications should be periodically monitored for changes in heart rate or blood pressure.

  • Patients should continue to use their medication for the treatment of ADHD as prescribed by their healthcare professional.

The FDA is releasing the following documents today:

Final Study Report: ADHD Medications and Risk of Stroke in Young and Middle-Aged Adults

Final Study Report: ADHD Medications and Risk of Serious Coronary Heart Disease in Young and Middle-Aged Adults


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