Stimulant Medications for Attention-Deficit/Hyperactivity Disorder - Cardiovascular Safety Review in Adults
December 14, 2011
FDA announced that medications used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) did not demonstrate an increase in risk for serious cardiovascular events in adults, according to data from two epidemiology trials in more than 150,000 adults (ages 25 - 64 years) taking medications for ADHD. One trial evaluated strokes and the other evaluated sudden cardiac deaths and heart attacks in adults. Several ADHD medications, including atomoxetine, pemoline, and various stimulants, were reviewed.
FDA reviewed the following products:
- Atomoxetine (Strattera®)
- Dexmethylphenidate HCl (Focalin®, Focalin XR®)
- Dextroamphetamine sulfate (Dexedrine®, Dexedrine Spansules®, Dextroamphetamine ER, Dextrostat®)
- Lisdexamfetamine dimesylate (Vyvanse®)
- Methamphetamine (Desoxyn®)
- Methylphenidate (Concerta®, Daytrana®, Metadate CD®, Metadate ER®, Methylin®, Methylin ER®, Ritalin®, Ritalin-LA®, Ritalin-SR®)
- Mixed amphetamine salts (Adderall®, Adderall XR®)
- Pemoline (Cylert® – no longer marketed)
No changes to FDA recommendations for ADHD medications were made:
- Avoid atomoxetine and stimulant products in patients with serious cardiac problems or in patients where increases heart rate or blood pressure could be harmful.
- Periodically monitor heart rate and blood pressure in patients taking ADHD medications.
Continue ADHD therapy according to product labeling and as prescribed by the healthcare provider. Medications that treat ADHD can cause increases in heart rate and blood pressure. Refer patients taking ADHD medications who develop chest pain, fainting, or shortness of breath immediately to a healthcare provider.
Additional information is available at the following links:
- FDA News Release
- 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
December 14, 2011. University of Utah Drug Information Service. Copyright 2011, Drug Information Service, University of Utah, Salt Lake City, Utah.