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Daytrana Lawsuit

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Daytrana is a patch that is used to treat attention-deficit hyperactivity disorder (ADHD). Unfortunately, the FDA has recently warned that Daytrana may a patient’s risk of serious psychiatric disorders, long-lasting erections (priapism), and cardiovascular events.

What is Daytrana?

Daytrana (methylphenidate patch) is a popular treatment for ADHD, one of the most common childhood brain disorders. Daytrana has an evenly-dispersed layer of methylphenidate and adhesive that is attached to a patient’s skin. It is manufactured by Noven Pharmaceuticals and was approved by the FDA in 2006.

Daytrana Linked to Permanent Skin Discoloration

Daytrana has been linked to over 50 cases of chemical leukoderma, a condition that causes permanent loss of skin color, according to a new Safety Warning from the FDA. 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 Long-Lasting Erections (Priapism)

In December 2013, the U.S. Food and Drug Administration (FDA) published a Drug Safety Communication after linking methylphenidate to a rare but serious side effect known as priapism.

Priapism is a long-lasting, painful, and unwanted erection is caused by blood trapped inside the penis. It is particularly dangerous in children, who may be less likely to tell an adult or recognize symptoms. Unfortunately, the longer treatment is delayed, the higher the risk of permanent erectile dysfunction.

Between 1997 and 2012, the FDA received 15 reports of priapism in association with methylphenidate. Priapism can occur in men of any age, and ages ranged from 8 to 33 years old (median age 12.5 years). Two patients needed surgery, including one who had blood drained from his penis and another who had a shunt implanted to divert blood-flow away from the penis.

FDA recommendation for children on Daytrana:

“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.”

Daytrana Heart Risks

Several years ago, the FDA warned about possible cardiovascular side effects of ADHD drugs after receiving 25 reports of death, including 19 in children, between 1999 and 2003. The FDA also received 54 reports of non-fatal cardiovascular events and required a “Boxed Warning” on the label.

Since then, a study of more than 1.2 million children has found no increased risk of cardiovascular events, prompting an FDA announcement in 2011. Even so, the FDA recommends that children on Daytrana should have routine check-ups for changes in heart rhythm or elevated blood pressure.

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

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