Daytrana Patch for Attention Deficit Wins FDA Approval
The first skin patch to treat attention deficit hyperactivity disorder in children will be sold under the name Daytrana. Designed to be worn for 9 hours, the ADHD patch contains methylphenidate, the same stimulant as that in Ritalin.
On Thursday, the US Food and Drug Administration formally approved the world’s first transdermal methylphenidate delivery system — the ADHD patch, to be sold under the name ‘Daytrana’.
As we reported in “ADHD Patch to be Sold as Daytrana”, the patch manufacturer had initially proposed a 12-hour version, but it is the 9-hour version which has been approved, in four doses: 10, 15, 20 and 30 milligrams. The ADHD patch will be labelled as an alternative treatment for children ages 6 to 12 years.
A report carried by the APA notes that the approval is not without controversy: apparently, the patch form of the drug was studied in just two short-term clinical trials that included roughly 765 children, and the ADHD patch has not been tested head-to-head against any other ADHD drugs, including the pill form of methylphenidate. The APA story reports:
Last year, an FDA reviewer initially said trials showed the patch produces troubling side effects too often to be considered safe. The reviewer later told a panel of experts that he had reconsidered his opinion and now judged the drug to be safe enough to approve. That panel, the FDA’s Psychopharmacologic Drugs Advisory Committee, voted unanimously to recommend approval.
That story also mentions that:
The Daytrana label for now will include the standard warnings other methylphenidate products bear, including cautionary statements about insomnia, decreased appetite and nausea, as well as a warning about sensitization, where patients can develop antibodies to the drug. Methylphenidate — in any form — cannot be taken if sensitization occurs.
Several CounsellingResource.com readers have expressed a keen interest in this new ADHD treatment, and we sincerely hope that Daytrana will prove helpful for them and their families.
Nearly 3.3 million Americans age 19 and younger used an ADHD drug last year, according to Medco Health Solutions
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This article was last reviewed by on Friday, 7th April 2006. You can leave a response below.
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7th April 2006
I think we should give ADD a new name. It could be called Hyper Vigilance. Perhaps this way we could allow ourselves to find out if our ability to see and take in many things at once is a gift or a curse.
10th April 2006
Hi Kathryn,
As you suggest with the idea of allowing ourselves to find out, my guess is the gift/curse is probably in the eye of the beholder — the person actually living with varying degrees of attention deficit, hyperactivity, or even hypervigilance (usually used to refer to a heightened awareness of potential threats).
All the best,
Greg
14th June 2006
Hello I was just curious to know if this Daytrana patch is still coming out and when it will be available. Will it be out in June or July of this year. Thank-you so much… !!!!
Naiches Clark
25th July 2006
I think that Daytrana is an excellent idea! My son forgets to take his meds in the morning and we usually have to hand them to him. And I think that anyone who does not have a child with ADHD needs to keep their opinions to themselves. ADHD is not an easy disorder to live with. My son struggles every day to maintain his grades in school and with tasks that some people think are easy to complete. And honestly anyone who does not medicate their child when he or she has been diagnosed with ADHD is neglecting their child.
6th November 2006
My grandson gets excellent grades in school he is 7 yrs old. He just doesn’t sit still in school, & he likes to bother the other kids.
I can’t understand why he needs to be on a drug.
I could see if he could not concentrate but he can.
Anyone out there with a comment?
9th December 2006
My son is having trouble staying focus in the class room. We are parents who want the best option for our son. We tried the pill form and wasn’t successful. My son can not swallow the pill. Tried different methods for the pill, including hiding it in his food, placing the pill in his drink, and holding his head back and dropping the pill in his mouth. So we stop giving it to him. Now with the patch, maybe hope. And for the parent who made the comment about parents who neglect their child for not giving the child medicine, parents just want was best for their child that all, including me and my husband. But i’m glad things are working out for you and your son. Maybe the Daytrana will help my son also.
9th April 2008
Hi i was just wondering if this patch is available in Canada.This would be perfect for my daughter as everyday is a struggle when pill not taken i could put on before i go to work and have no problems.