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U.S. Department of Health and Human Services

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Stimulant Medications used in Children with Attention-Deficit/Hyperactivity Disorder - Communication about an Ongoing Safety Review

Products involved include: Focalin, Focalin XR (dexmethylphenidate HCl ); Dexedrine, Dexedrine Spansules, Dextroamphetamine ER, Dextrostat (dextroamphetamine sulfate); Vyvanse (lisdexamfetamine dimesylate); Desoxyn (methamphetamine); Concerta, Daytrana, Metadate CD, Metadate ER, Methylin, Methylin ER, Ritalin, Ritalin-LA, Ritalin-SR (methylphenidate); Adderall, Adderall XR (mixed salts amphetamine); Cylert (pemoline) and generics.

 

[UPDATED 12/12/2011] 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. Patients should continue to use their medicine for the treatment of ADHD as prescribed by their healthcare professional.

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.
 

[UPDATED 11/01/2011] FDA notified the public that a large, recently-completed study in children and young adults treated with medication for Attention-Deficit/Hyperactivity Disorder (ADHD) has not shown an association between use of certain ADHD medications and adverse cardiovascular events. FDA continues to recommend that healthcare professionals prescribe these medications according to the professional prescribing label. See the Data Summary of the FDA Drug Safety Communication for more information.

 

Audience: Pediatricians, Neuropsychiatric healthcare professionals

[Posted 06/15/2009] FDA notified healthcare professionals that it is providing its perspective on study data published in the American Journal of Psychiatry on the potential risks of stimulant medications used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in children. This study, funded by the FDA and the National Institute of Mental Health (NIMH), compared the use of stimulant medications in 564 healthy children from across the United States who died suddenly to the use of stimulant medications in 564 children who died as passengers in a motor vehicle accident.The study authors concluded that there may be an association between the use of stimulant medications and sudden death in healthy children. Given the limitations of this study’s methodology, the FDA is unable to conclude that these data affect the overall risk and benefit profile of stimulant medications used to treat ADHD in children. FDA believes that this study should not serve as a basis for parents to stop a child’s stimulant medication. Parents should discuss concerns about the use of these medicines with the prescribing healthcare professional. Any child who develops cardiovascular symptoms (such as chest pain, shortness of breath or fainting) during stimulant medication treatment should immediately be seen by a doctor.

FDA is continuing its review of the strengths and limitations of this and other epidemiological studies that evaluate the risks of stimulant medications used to treat ADHD in children. FDA and the Agency for Healthcare Research and Quality are sponsoring a large epidemiological study that will provide further information about the potential risks associated with stimulant medication use in children. The data collection for this study will be complete later in 2009.

[11/01/2011 - Drug Safety Communication: Safety Review Update of Medications Used to Treat Attention-Deficit/Hyperactivity Disorder (ADHD) - FDA]

[06/15/2009 - Communication About An Ongoing Safety Review - FDA]
[06/15/2009 - News Release - FDA]
[06/15/2009 - Stimulant Medications Prescribing Information, Medication Guides - FDA]