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FDA Drug Safety Podcasts for Healthcare Professionals: Safety Review Update of Medications used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in adults

Listen to this Podcast

Narrator: Welcome to the FDA Drug Safety Podcast for Healthcare Professionals from the Division of Drug Information. Today's topic: Safety review update of medications used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in adults.


Kara Daniel, a pharmacist in the Division, will provide you with additional information about this Communication.

Guest Speaker: On December 12, 2011 the Food and Drug Administration issued a Drug Safety Communication updating its communication on the ongoing cardiovascular safety review of medications used for treating ADHD, many of which are known to increase heart rate and blood pressure. A large, recently-completed study that included one study that evaluated heart attacks and sudden deaths in a sample of adults, and a second study that assessed strokes in these adults, has not shown an increased risk of serious adverse cardiovascular events in adults treated with ADHD medications.

The medications studied include stimulants (such as amphetamine products and methylphenidate), atomoxetine, and pemoline (which is no longer marketed).

FDA recommendations for the use of medications to treat ADHD have not changed. Healthcare professionals should continue to take special note that:

  • Stimulant products and atomoxetine should generally not be used in patients with serious heart problems, or 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 medicine for the treatment of ADHD as prescribed by their healthcare professional.

In the two recently-completed epidemiologic studies, data were analyzed from over 440,000 adults aged 25-64 years, including over 150,000 adults treated with medications for ADHD. One study evaluated heart attacks and sudden cardiac deaths in this sample of adults, and the second study assessed strokes in these adults. Together, these studies were designed to evaluate the potential increased risk of heart attack (myocardial infarction, or MI), sudden cardiac death, or stroke that could be associated with the use of ADHD medications. The adult study is being published in the Journal of the American Medical Association disclaimer icon on December 12, 2011.

On November 1, 2011, FDA communicated the results of a study in children and young adults treated with ADHD medications that also did not show an increased risk of serious cardiovascular events.


At this time, FDA recommends that Healthcare Professionals be aware that:

  1. A large retrospective cohort study in adults (aged 25-64 years) did not show an increased risk of MI, stroke, or sudden cardiac death with use of ADHD medications.
  2. They should continue to prescribe drugs used for the treatment of ADHD according to the professional prescribing directions.
  3. Adverse events involving ADHD medications should be reported to the FDA MedWatch program at www.fda.gov/medwatch.

Narrator: Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information. A link to this communication, including the complete data summary can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.


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