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Metadate CD Lawsuit

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Metadate CD (methylphenidate HCl) is a treatment for ADHD, one of the most common childhood brain disorders. Unfortunately, Metadate CD can have serious side effects in children — delayed growth (height and weight), seizures, deadly heart problems, priapism (long-lasting erection), permanent sexual dysfunction, serious psychiatric disorders, and more.

What is Metadate CD?

Metadate CD (methylphenidate), manufactured by UCB Inc., is an oral prescription medication that is primarily used for children with ADHD (attention-deficit hyperactivity disorder). It was approved on April 2001. Each capsule contains 70% long-acting beads and 30% short-acting beads, which are designed to replace 2 doses of methylphenidate.

Metadate CD and Long-Lasting Erections

December 17, 2013 — The U.S. Food and Drug Administration (FDA) has published a Safety Warning about the risk of priapism from Metadate CD and other methylphenidate ADHD drugs. This is an erection of the penis lasting 4 hours or more that is caused by blood trapped inside the penis and not sexual stimulation. Priapism can cause excruciating pain, swelling, tissue damage, and permanent erectile dysfunction. It is a medical emergency that may need to be treated with surgery.

FDA Recommendation for Metadate CD and Priapism

The FDA has concluded that priapism from methylphenidate appears to be rare. However, because priapism can potentially cause lifelong erectile dysfunction, doctors should inform patients and caregivers about the importance of seeking emergency medical attention for erections that are painful, prolonged, or unusually frequent.

The FDA is also particularly concerned about the risk of priapism in children on Metadate CD. Between 1997-2012, the FDA received 15 reports of priapism associated with methylphenidate, including 12 cases in children under 18 years old. The FDA warns:

“Younger males, especially those who have not yet reached puberty, may not recognize the problem or may be embarrassed to tell anyone if it occurs.  All male patients and their caregivers should be taught the signs and symptoms of priapism and the importance of seeking immediate medical treatment if it occurs.”

Cardiovascular Warnings for Metadate CD

The Prescribing Information for Metadate CD includes warnings about the risk of deadly cardiovascular events in children with heart defects. Furthermore, children on Metadate CD should be tested routinely for changes in blood pressure or heart rhythm. Metadate CD should not be used in people with high blood pressure, chest pain, heart failure, recent heart attack, or other serious cardiovascular problems.

Heart Risks of Metadate CD

  • 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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