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Focalin XR is a popular treatment for attention-deficit hyperactivity disorder (ADHD) in children. Recently, the FDA has warned that Focalin XR and other ADHD drugs may increase a child’s risk of priapism — a long-lasting erection that can cause permanent sexual dysfunction. Other severe side effects include cardiovascular disorders and psychiatric events.

What is Focalin XR?

Focalin XR is a d-isomer of methylphenidate, which means it is a more pure form of methylphenidate. The active ingredient in Focalin XR is dexmethylphenidate, an extended-release once-daily capsule manufactured by Novartis Pharmaceuticals. It begins working within 30 minutes and provides 12 hours of ADHD symptom control for children aged 6-12 years.

Focalin XR and Priapism

In December 2013, the U.S. Food and Drug Administration (FDA) warned about rare risk of priapism, an erection lasting 4 hours or more caused by blood trapped inside the penis. It is an emergency medical condition that may need to be treated with surgery.

At least 15 people have suffered priapism after taking methylphenidate between 1997-2012, including at least 12 cases in children. Priapism can occur in males of any age, but the risk in children is that they may not recognize symptoms or they may be too embarrassed to tell an adult. If treatment is delayed, priapism can cause lifelong erectile dysfunction.

The Prescribing Information for Focalin XR includes the following warning:

“Painful and prolonged erections (priapism) have occurred with methylphenidate. If you or your child develop priapism seek medical help right away. Because of the potential for lasting damage, priapism should be evaluated by a doctor immediately.”

Focalin XR and Cardiovascular Side Effects

Serious cardiovascular events, including sudden death, have occurred in association with stimulant ADHD drugs in children who have heart defects or other heart problems. Therefore, Focalin XR generally should not be used in patients with heart defects, cardiomyopathy, heart rhythm abnormalities, coronary artery disease, or other serious heart problems. In addition, patients on Focalin XR should also have periodic check-ups to monitor changes in heart rate and blood pressure.

Cardiovascular risks of Focalin XR:

  • Hypertension (high blood pressure)
  • Heart rhythm is fast, uneven, or pounding
  • Cardiac arrhythmia or palpitations
  • Cardiomyopathy
  • Heart attack
  • Stroke
  • Sudden cardiac death