WASHINGTON (Reuters) – U.S. health regulators on Thursday approved the first skin patch to treat children with attention deficit hyperactivity disorder, saying it would help parents give the drug to children who have trouble taking pills.
The Daytrana patch, made by Britain’s Shire Pharmaceuticals Group Plc and Noven Pharmaceuticals Inc., will deliver via the skin a generic version of one of the most popular ADHD treatments — Swiss drug maker Novartis AG’s Ritalin.
The patch will carry the same warnings against use in children who already have heart problems carried by all ADHD drugs, which have come under recent scrutiny for possible psychotic behavior such as hallucinations as well as broader heart concerns.
Some experts have called for additional warnings on the drugs, but FDA’s Division of Psychiatry Products Director Dr. Thomas Laughren said the agency was still sorting out the data.
“As with all ADHD products (the patch) should be used as part of a comprehensive treatment program for ADHD, including educational and social elements,” he said.
Daytrana will also carry a separate warning about possible skin sensitivity that includes redness and bumps.
Ritalin, known generically as methylphenidate, is one of the most commonly abused drugs among young people. Johnson & Johnson also sells a version called Concerta.
With the patch, some experts have expressed concerned because the drug can enter the blood stream more directly than with a pill. Some also have questioned whether the patch could be shared or abused by being cut up and chewed.
FDA’s Laughren said there was no sign of such problems during clinical trials, but the companies had promised to monitor for potential misuse.
“Whether or not this will be a problem when it’s used more broadly (in the market) is unknown,” he said.
He added that the patch would make it easier for some parents to treat their children. Outside experts told the agency “a substantial fraction of children have difficulty taking pills,” he said.
Daytrana is a once-daily patch for children ages 6 to 12 that is supposed to be applied early in the morning and removed 9 hours later. It should be worn on the hip, alternating left and right sides every day, and comes in fourth strengths.
Besides skin irritation, side effects can include insomnia, anorexia, significant weight loss, nausea and vomiting.
A Shire representative had no immediate comment on the approval. Representatives for Miami-based Noven could not be immediately reached.