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

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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 children and young adults.

This update is in follow-up to the FDA Communication about an Ongoing Safety Review of Stimulant Medications used in Children with Attention-Deficit/Hyperactivity Disorder (ADHD) 

LCDR Misu Ahn, a U.S. Public Health Service pharmacist in the Division, will provide you with additional information about this Communication.

Guest Speaker: On November 1, 2011, the Food and Drug Administration issued a Drug Safety Communication updating the public that a large, recently-completed study in children and young adults treated with medication for ADHD, has not shown an association between use of certain ADHD medications and adverse cardiovascular events. These adverse cardiovascular events include stroke, myocardial infarction, or MI, and sudden cardiac death.

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

This study did not find an association between use of ADHD medications and cardiovascular events. FDA continues to recommend that healthcare professionals prescribe these medications according to the professional prescribing label.

Healthcare professionals should 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.

This cohort study, conducted with 1,200,438 children and young adults (aged 2-24 years) and 2,579,104 person-years of follow-up, including 373,667 person-years of current use of ADHD drugs, only found 7 serious cardiovascular events in current users. Person-years is the total sum of the years that each person in a study has been under observation. Study findings reported no evidence of increased risk of serious cardiovascular effects among children and young people who use ADHD medications. The possibility of a small to modest increase in risk cannot be ruled out because of the small number of serious cardiovascular events observed in the patients studied.

This is the first of three separate but related studies that were sponsored by the FDA and the Agency for Healthcare Research and Quality. These studies were designed to evaluate the potential increased risk of heart attack, stroke or sudden cardiac death that could be associated with the use of ADHD medications. FDA will communicate the results of the other two studies (performed in adults) when our review of the study results is complete.

The final study report entitled: Final Report: Attention Deficit Hyperactivity Disorder Medications and Risk of Serious Cardiovascular Disease in Children and Youth is being released on November 1, 2011. FDA is also releasing the Statistical Review of the Final Report for Observational Study: Attention Deficit Hyperactivity Disorder Medications and Risk of Serious Cardiovascular Disease in Children and Youth.

This study was published in the New England Journal of Medicine on November 1, 2011 and can be viewed at the Journal's website or by using the link available in the complete Drug Safety Communication at FDA's website.

With this communication, FDA is providing the Agency's analysis of the most up-to-date information that is currently available to healthcare professionals and families.

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

  1. A large retrospective cohort study in children and young adults aged 2-24 years, did not show an association between use of ADHD drugs and cardiovascular events, which include MI, stroke or sudden cardiac death. These study results were not consistent with the increase in sudden death estimated in a previous study; however a small to modest increase in risk cannot be excluded.
  2. 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 can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

Follow us on Twitter @FDA_Drug_Info for up to the minute important drug information. Know the moment it happens.

 

 

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