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Many parents agree that it’s difficult to get a child to take a pill. In response, Daytrana, a patch that delivers a dose of an ADHD drug, proved to be a success.
Known as a methylphenidate transdermal system, Daytrana is said to increase a child’s attention while decreasing restlessness. The patch, applied to the hip and worn 9 hours per day, gives the right dose needed to control the condition.
Yet, a recent FDA warning shows that Daytrana has serious side effects. Particularly, reports link it with chemical leukoderma, a condition resulting in permanent loss of skin color due to chemical exposure.
Background
The FDA approved Daytrana in 2006. However, during its first four years on the market, the patches went through 10 recalls. Two more followed after 2010.
It proved to be a popular drug, with about 100,000 to 135,000 prescriptions dispensed per year since 2010.
Yet, in more recent years, manufacturer Shire faced a lawsuit from the Department of Justice over its marketing materials. The company claimed, without substantiated evidence, that patients were less likely to abuse Daytrana than Adderall. In response, the company paid $60 million, most of which went to state and federal governments.
In June 2015, the FDA put out its warning concerning its link to chemical leukoderma. The organization’s database showed that, between 2006 and 2014, 51 cases involved patients developing permanent discoloration at the patch site and on other areas of the body. The splotches went up to eight inches in diameter and emerged any time from two months to four years after starting Daytrana.
While the FDA didn’t take Daytrana off the market, it recommended:
- Watching for new areas where the skin changes color, particularly in young children.
- To rotate the patch daily, using different areas on both hips.
Along with these concerns, data has linked Daytrana use with developing psychiatric disorders, cardiovascular issues, and priapism, in which a patient develops a long-lasting and painful erection. In 2013, the FDA issued a safety communication about this latter point, stating that, because of this concern, Daytrana is dangerous for children and, if treatment is delayed, could result in permanent erectile dysfunction.
Lawsuits
While chemical leukoderma doesn’t affect any areas aside from the skin’s appearance, patients have felt self conscious, embarrassed, and stressed as a result. Because the spot remains a permanent white or light color, the patient has no other options but to cover up the area.
Stemming from the condition’s permanence, patients and their families have started filing lawsuits against Shire. If you took Daytrana, only to have a similar experience, it’s time to hold the manufacturer accountable for its negligence.
