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Focalin XR Lawsuit


Focalin XR is an extended-release stimulant medication for ADHD. Unfortunately, it has been associated with serious side effects in children — seizures, growth delays, priapism (long-lasting erections), cardiovascular events, psychiatric disorders, and more.

What is Focalin XR?

Focalin XR is a medication developed by Novartis Pharmaceuticals that is primarily used to treat attention-deficit hyperactivity disorder (ADHD) in children. The active ingredient, dexmethylphenidate, is a d-isomer of methylphenidate, meaning it is a more pure form of the drug. Focalin XR is taken once a day, it begins working within 30 minutes, and works for 12 hours.

Focalin XR and Long-Lasting Erections (Priapism)

The U.S. Food and Drug Administration (FDA) has published a Drug Safety Communication warning about priapism, a rare side effect of Focalin XR. Priapism is an erection lasting 4 hours or more that is not caused by sexual arousal, but rather blood trapped inside the penis. It is a medical emergency that can cause excruciating pain, severe swelling, and may need to be treated with hospitalization and surgery.

The FDA has received 15 reports of priapism in association with methylphenidate ADHD drug, in adults and children between the ages of 8 and 33 years old. Two people needed surgery, including one who had a shunt implanted and another who had blood drained from his penis using a needle.

Although priapism is rare, the FDA required Novartis to add the following warning to the Prescribing Information for Focalin XR:

“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

Focalin XR and other stimulant ADHD drugs have been associated with serious cardiovascular events, including sudden death, in children with heart defects or pre-existing heart disease. Therefore, patients on Focalin XR should be monitored routinely for changes in blood pressure or heart rhythm. In addition, Focalin XR should not be used in people with heart defects, cardiomyopathy, heart rhythm abnormalities, coronary artery disease, or other severe heart problems.

Focalin XR cardiovascular risks:

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

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