No Longer Accepting Cases

Metadate CD (methylphenidate HCl) is a popular treatment for children with ADHD. Unfortunately, children are at risk of developing severe side effects like priapism (long-lasting erections), lifelong sexual dysfunction, growth delays, seizures, heart problems, and more.

What is Metadate CD?

Metadate CD (methylphenidate) is a prescription medication for attention-deficit hyperactivity disorder (ADHD). Each capsule of Metadate CD contains 30% short-acting beads and 70% long-acting beads. This once-daily formulation is designed to replace 2 doses of methylphenidate, which avoids patients taking medication in school.

Metadate CD and Long-Lasting Erection

Metadate CD is associated with a wide range of adverse events in children, including growth delays (height and weight), seizures, visual problems, and long-lasting erections known as priapism. Patients who develop abnormally long, frequent, or painful erections of the penis should seek emergency medical attention. Without treatment, priapism can cause permanent erectile dysfunction.

FDA Warning for Metadate CD and Priapism

The FDA required Safety Warnings about Metadate CD and priapism after receiving 15 reports of the side effect in patients on methylphenidate between 1997-2012. Of the 14 cases reporting an age, 12 occurred in children, including one who was only 8 years old. Some patients were hospitalized, and two needed surgery — including one who had a needle aspiration to drain blood from the penis, and another who had a shunt implanted.

Children are at particular risk from priapism because they may be less likely to recognize symptoms, tell an adult, or seek medical attention. Therefore, male patients and their caregivers should be taught the signs and symptoms of priapism. According to the FDA:

“Priapism associated with the use of methylphenidate products appears to be rare. However, given the potential for serious outcomes, it is important that patients, caregivers, and health care professionals be aware of the need to seek immediate medical attention for priapism to avoid permanent harm.”

Metadate CD and Heart Risks

Metadate CD is contraindicated in people with high blood pressure, irregular heart rhythm, heart failure, recent heart attack, chest pain, or other risk-factors for cardiovascular events. In children and teenagers with heart defects, sudden death has been reported in association with stimulant ADHD drugs. Therefore, Metadate CD should not be used in patients with heart defects, cardiomyopathy, heart rhythm abnormalities, or other heart 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