No Longer Accepting Cases

Daytrana (methylphenidate) is a popular treatment for ADHD (attention-deficit hyperactivity disorder) that has been sold by Noven Pharmaceuticals since 2006. The FDA has recently warned that Daytrana may increase the risk of priapism (long-lasting erections), cardiovascular events, and serious psychiatric disorders.

What is Daytrana?

Daytrana is a transdermal patch for delivering methylphenidate, a stimulant drug that is used to treat ADHD, which is one of the most common childhood brain disorders. Daytrana consists of an evenly-dispersed blend of methylphenidate and adhesive that is released into a patient’s body through the skin.

Daytrana Linked to 50 Cases of Chemical Leukoderma

June 2015 — The FDA has issued a Safety Warning about the risk of permanent skin discoloration from Daytrana. Between April 2006 and December 2014, Daytrana was linked to at least 50 cases of chemical leukoderma, a condition that causes the skin to permanently lose color due to exposure to chemical compounds. Click here to read more.

According to the agency:

“Permanent loss of skin color may occur with use of the Daytrana patch. … This skin condition, called chemical leukoderma, is not physically harmful, but it is disfiguring and not thought to be reversible so can cause emotional distress.”

Daytrana and Priapism (Long-Lasting Erections)

December 17, 2013 — The U.S. Food and Drug Administration (FDA) has issued a Drug Safety Communication to warn about priapism, a rare but serious side effect of Daytrana. They warn that children may be less likely to recognize symptoms or tell an adult, which increases the risk of complications.

Priapism is a long-lasting, painful, and unwanted erection that occurs when blood is trapped inside the penis. Without emergency medical treatment, priapism can cause extreme pain, swelling, and tissue damage in the penis that causes permanent erectile dysfunction.

There were 15 cases of priapism reported to the FDA between 1997-2012 in association with methylphenidate. The median age for patients who experienced priapism was 12.5 years (range 8-33 years). Some cases occurred after an increase in the dose of methylphenidate, but it also occurred when the drug was stopped temporarily. Two patients needed surgery, including one who had a shunt placed, and another who had a needle aspiration to drain blood from the penis.

FDA recommendation:

“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.”

Heart Risks of Daytrana

In 2011, the FDA announced that a study of over 1.2 million children found no association between methylphenidate and cardiovascular events. However, they warn that Daytrana and other stimulant ADHD drugs should not be used in children with heart defects. During treatment, children should be periodically monitored for elevated blood pressure or changes in heart rhythm.

Daytrana cardiovascular side effects may include:

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