FDA Drug Safety Communication

FDA is updating 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. These adverse cardiovascular events include stroke, heart attack (myocardial infarction or MI), and sudden cardiac death.

The medications studied include stimulants (amphetamine products and methylphenidate), atomoxetine, and pemoline (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.

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

ADHD medications involved in this safety review included:

Stimulants

methylphenidate (Concerta, Daytrana, Metadate CD, Metadate ER, Methylin, Methylin ER, Ritalin, Ritalin-LA, Ritalin-SR)

dexmethylphenidate HCl (Focalin, Focalin XR)

dextroamphetamine sulfate (Dexedrine, Dexedrine Spansules, Dextroamphetamine ER, Dextrostat)

lisdexamfetamine dimesylate (Vyvanse)

amphetamine, mixed salts (Adderall, Adderall XR)

methamphetamine (Desoxyn)

Non-stimulants

pemoline (Cylert-no longer marketed)

atomoxetine (Strattera)

View the full FDA Drug Safety Communication on FDA.gov