Two of my most-read blogs were about generic forms of Concerta available in 2013-14. The FDA had allowed companies to manufacture and sell tablets that were not the same as Concerta. People across the country noticed the change immediately. I started seeing patients who had been well controlled on Concerta for a long time who suddenly were not able to focus, were more angry, and had other focus and behavior problems. Initially I had no idea there was a new generic, but one mother sent me a picture of the new pill and I knew instantly it could not be the same.
Now I've heard there will be new generics from Trigen Laboratories, Mylan and Impax Laboratories that do not use the special delivery system of Concerta once again. I'm worried because it took many many months of people filing reports with the FDA through MedWatch before the FDA finally stopped allowing the substitution. I hope the newly approved versions work better than the previous editions, but am worried not only because they don't use OROS technology, but there are several new versions coming to market and each could be different.
I have heard that the previously available OROS generic (made in the same factory as the name brand Concerta and the same exact pill but with a different label) will no longer be available. If this is true, options will be to pay for the name brand or go with a new version of the medicine.
|These are all OROS type methylphenidate HCl ER (Concerta)|
What makes Concerta unique?
You can tell if you have the OROS tablets if they have a small dimple in one end:
The new generics
What's good about the new generics?
The Trigen version is available as a 72 mg tablet. The original Concerta is not able to be made at that strength. You can see from the photos above that the pills get bigger with increasing dosages, and the OROS system has limits to how much it can hold. For people who need 72 mg, they must take two of the 36 mg OROS tablets. Since patients pay by the pill and they need 60 pills/month instead of 30, this can be quite a bit more expensive.
What should you do if the pills change - especially if they don't work?
- Talk to your HR representative who deals with the insurance company.
- Call your insurance company directly. Send them e-mails and snail mail.
- Ask your physician to write a letter on your behalf.
In each of the above situations, include why your family member needs the OROS technology. Give examples of how it works better than the other extended release methylphenidates and why the amphetamine class of medication failed (if tried).
- People were able to get the FDA to look into the issue the last time a different tablet was substituted by submitting complaints to MedWatch. It took a long time, but the FDA finally agreed that there are significant differences and the other substitutions were no longer allowed. It's easy and free. Please submit to MedWatch if you have any concerns!