Shire Recalls Daytrana ADHD Patches in ‘Voluntary Market Withdrawal’
Shire admits there’s a problem with the Daytrana ADHD patch, and fixes it. Following strong feedback from our readers and other users of the Daytrana patch, the company has announced a ‘voluntary market withdrawal’ of faulty Daytrana patches. The company says it is now using an ‘enhanced process’ to ensure the backing of the patch can be easily removed.
Sometimes, feedback works.
With a regular stream of user reports coming directly from this website, as well as from many other patients and doctors, Daytrana patch manufacturer Shire Pharmaceuticals has admitted there is a problem with large numbers of the methylphenidate transdermal system patches for ADHD.
The official product withdrawal notice is available directly from Shire, and here is the letter which has been sent out to patients and caregivers, including the lot numbers for affected batches and instructions on what to do if your medication is affected:
Dear Daytrana™ Patients and Caregivers:
Shire wants to advise you of the company’s decision to implement a voluntary market withdrawal of limited portions of the Daytrana™ patches. Shire is taking this proactive step not due to safety and efficacy issues, but due to feedback from patients and caregivers who have experienced difficulty removing the release liner from some Daytrana™ patches.
Shire expects the remaining supply of Daytrana™ will offer patients and caregivers improved ease of use when peeling the release liner off the patch. All Daytrana™ patches, including those that are part of the voluntary market withdrawal, can continue to be used unless the release liner cannot be removed or the patches are damaged while being opened. The current supply levels of Daytrana™ are sufficient, ensuring that those patients who currently use Daytrana™ and those patients looking for an alternative ADHD treatment option will be able to have their prescriptions filled with Daytrana™ patches with an improved ease of use.
Here is important information you should know about this voluntary market withdrawal:
Are the affected lots safe and effective?
Shire is taking this proactive step not due to safety and efficacy issues, but due to feedback from patients and caregivers who have experienced difficulty removing the release liner from some Daytrana™ patches. All Daytrana™ patches, including those affected by the voluntary market withdrawal, can be used unless the release liner cannot be removed or the patches are damaged.
How do I know if my current supply of Daytrana™ is affected by this voluntary market withdrawal?
Only those Daytrana™ packages that have an expiration date of March 31, 2009 or earlier or lots 2563511, 2563611, or 2570411 are impacted by this voluntary market withdrawal. All Daytrana™ patches including those affected by the voluntary market withdrawal can continue to be used unless the patches are damaged when opening or the release liner cannot be removed.
What should parents and caregivers of patients prescribed Daytrana™ do with their packages of Daytrana™ if they meet the criteria for the voluntary market withdrawal?
They have two options:
- If the release liners can be easily removed and the patches are not damaged, use the patches as directed.
- Or, if the patches cannot be used, call the Shire Customer Service/DaytranaCare line at 1-800-828-2088, option 1.
Please see Important Safety Information below and accompanying Full Prescribing Information.
Please describe what you mean by “damaged.”
If it appears to you that anything about a patch looks unusual, please do not use. Damaged patches should be discarded according to the directions in the Daytrana™ package insert.
What changes have been made to Daytrana™?
We have increased the release coating on the release liner. No changes to the medication, itself, have been made.
At Shire our patients always come first and Shire is dedicated to providing you with the information you need to make informed decisions related to your child’s care. If you have further questions after reviewing this information, please call us at 1-800-828-2088, option 1.
Sincerely,
Joel Cohen, MD
Medical Director, Global Medical Affairs
Shire Pharmaceuticals
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This article was last reviewed by on Thursday, 6th September 2007. You can leave a response below.
The URL of this page is:
http://counsellingresource.com/features/2007/09/06/daytrana-patch-withdrawal/
14 Responses to “Shire Recalls Daytrana ADHD Patches in ‘Voluntary Market Withdrawal’”
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Vanessa14
I was wondering when the patch was going to be on the market again. My pharmacy told me that they do not know when the Daytrana Patch will be available in order to fufill my precription. Do you know when it will be available?
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Christie13
I’ve only been on the Daytrana patch for a short time. It is a nightmare to put on considering the backing doesn’t peel easily. I thought the manufacturer recalled these patches to fix the problem? If it weren’t for the trouble putting them on I would be completely satifsfied with the patches and the results. I’m going to talk to my doctor because if this is going to be a new battle each and every day it is not worth it. Besides half the time the medicine comes off anyways. There’s got to be a better system they can come up with. If Nicoderm can make it easy for their people who wish to quit smoking to put their patch on you’d think Shire could figure something out to help their valued customers?
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Lisa Beard12
Our 9yr old son was diagnosed with ADHD and we started on the Daytrana patches. We went that route because of the ease of being able to take it off and the medicine wear off.
We had issues with peeling the backing off of the batch of 10mg patches that we started with, and I too, thought it was just me. We have had better success with the 15mg patches. I just thought we had a bad batch. Being a nurse, I know that can happen with certain medications and manufacturers.
Our son likes the patch because he has some control of it and he doesn’t have to swallow it. We do have battles when he has to take a pill of any sort. He removes the patch when he gets to his after school program so that it is not on too late. With the first doses, we had to trial the removal time to get adequate coverage and adequate sleep.
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gloria11
myson is thirteen and has struggled in the past with swallowing the pills that he was taling for his adhd, so when i heard about the daytrana patch i was thrilled until i had to peel one off:( it was a nightmare for me. I’m just glad to know that i wasn’t the problem and i to think that some of the medication is coming off with the backing not to mention that it then won’t stay put after it has been applied and i can’t afford to waste medication.
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