View Full Version : FDA: some generic Concerta may *not* be equivalent.


namazu
11-13-14, 05:05 PM
The FDA issued a statement today (http://www.fda.gov/Drugs/DrugSafety/ucm422568.htm) that the generic methylphenidate ER pills produced by Mallinckrodt and Kudco may not, in fact, be bioequivalent to brand-name Concerta (and the authorized generics). These generics may not be as effective for some patients.

Here's an FAQ for consumers from the FDA. (http://www.fda.gov/Drugs/DrugSafety/ucm422569.htm)

Here are some relevant excerpts from the statement:
An analysis of adverse event reports, an internal FDA re-examination of previously submitted data, and FDA laboratory tests of products manufactured by Mallinckrodt and Kudco have raised concerns that the products may not produce the same therapeutic benefits for some patients as the brand-name product, Concerta...

[...]

In some individuals, the Mallinckrodt and Kudco products may deliver drug in the body at a slower rate during the 7- to 12-hour range. The diminished release rate may result in patients not having the desired effect.

[...]

Mallinckrodt and Kudco products are still approved and can be prescribed, but are no longer recommended as automatically substitutable at the pharmacy (or by a pharmacist) for Concerta.


An article from the Wall Street Journal (http://online.wsj.com/articles/mallinckrodt-says-fda-reclassified-adhd-generic-drug-1415888276) notes that Mallinckrodt protests the FDA's claim.

mollymae76
11-13-14, 05:56 PM
Sweet Vindication!

This is SO true! I had a huge deal with the pharmacy who filled my son's rx with this brand about a year ago. I really had to go to bat and become "that mom". The pharmacist finally let me exchange it for the Watson brand. It's evident just on a simple visual inspection, that the time release mechanism is not in place.

My son only took it twice and said it made him feel "creepy" (his word for anxiety, I surmised). We noticed that he was on edge and not his normal easy-going self.

outlawdeputy
01-09-15, 07:46 AM
Never understood how Concerta got generic anyway because it Alza's delivery mechanism system that made it unique. When Concerta first came out it was incredibly expensive as compared to ($200+ and 30) and it was the delivery that it was said justified the price.
My last Rx was over $400 for Concerta and the generic was only slightly less despite that all generics just seemed to be coated tablets.

Turbochica
01-09-15, 02:08 PM
My 21 yo daughter went to the Pharmacy today to get her Concerta prescription filled and she was told that Concerta is no longer generic.

The OMG moment is that now the cost of the medication went from 5 to 100 dollars for the prescription

OH MY Flippin Pancakes!!!!!

I went to my favorite website for medical information and this is what I found out
Here is a quick ADD friendly summary of the article of the main points.

Based on an analysis of data, FDA has concerns about whether or not two approved generic versions of Concerta tablets (methylphenidate hydrochloride extended-release tablets), used to treat attention-deficit hyperactivity disorder in adults and children, are therapeutically equivalent to the brand-name drug.

FDA has not identified any serious safety concerns with these two generic products. Patients should not make changes to their treatment except in consultation with their health care professional.



In some individuals, the Mallinckrodt and Kudco products may deliver drug in the body at a slower rate during the 7- to 12-hour range. The diminished release rate may result in patients not having the desired effect.


As a result, the FDA has changed the therapeutic equivalence (TE) rating for the Mallinckrodt and Kudco products from AB to BX. This means the Mallinckrodt and Kudco products are still approved and can be prescribed, but are no longer recommended as automatically substitutable at the pharmacy (or by a pharmacist) for Concerta.





http://www.fda.gov/drugs/drugsafety/ucm422568.htm

finallyfound10
01-10-15, 01:40 PM
I'm dealing with this issue now too! I just got a new job and have insurance now and it's been a nightmare. When I didn't have insurance and was on Johnson & Johnson Patient Assistance Program I got the right one. I'm currently unmedicated!!

Gina Pera is the "expert" on this debacle and has been instrumental in raising awareness and getting people to report the "True generic" which is the bad one leading the FDA to get involved.

I educated myself this way:

Read the blog post below by Gina on the two types of generics, then when I got that straight, read through the rest of her blog posts about it and the probably thousands of comments. You need to educate yourself because you will need to talk with the insurance company and possibly several pharmacists. I've talked to three so far at different retail stores.

http://adhdrollercoaster.org/the-basics/a-recap-consumers-guide-to-generic-concerta/#more-3208

In dealing with my insurer, I learned that I will probably have to:

1.) Get my MD to petition my insurer to cover the "Authorized generic" which is the good one.

2.) Get my MD to write my script for the "OROS only" which is medication delivery system the "Authorized generic", the good one.


Also, I found out from the pharmacist at CVS that there is a nationwide shortage on the "Authorized generic"!!! To verify this info I Googled Concerta shortage and clicked the 4th link down saying "Methylphenidate hydrochloride ER Capsules/Tablets- FDA" accessdata.fda.gov is where it takes you.

Good luck!!!!

dag nab it
01-14-15, 09:52 AM
If your script is for generic methylphenidate ER, does this mean the pharmacy cannot fill it with Mallinckrodt? If there's a shortage, what does the M.D. have to write on the script to ensure that the script gets filled with any available form of the medication?

I ask because my teenager had been taking Watson, and asked for his dose to be increased in the fall because he could not pay attention that well in school. The higher dose worked. His last script was filled with Mallinckrodt in late December. Because of winter vacation, he did not take it until January. He has not noticed any difference. I've caught him though doing some homework once he gets home - he used to wait until later in the evening to get started. But at this point I cannot judge whether it's the medication or some other factor.

Sickle
02-08-15, 10:36 AM
congrats... I hope they do the same with Actavis Adderall XR... those were diet pills with panic attacks and diarrhea and didn't do anything to calm me down. I take it all of the younger versions of myself are on the Concerta and were driving everyone nuts like I used to and there was a massive mom smackdown on the MedWatch line for the FDA so it may take time but pharmacists even said nobody likes them but the insurance will cover those and charge the brand price on the two Authorized Generics that Shire sells to Barr and Impax.

It's bad enough that I am just "settling" with Adderall because nobody covers dexedrine on the plans in my area unless I didn't work and was on full blown Medicaid. It kind of sucks.

namazu
02-08-15, 01:58 PM
If your script is for generic methylphenidate ER, does this mean the pharmacy cannot fill it with Mallinckrodt? If there's a shortage, what does the M.D. have to write on the script to ensure that the script gets filled with any available form of the medication?

I think as long as the prescription says "methylphenidate ER", without specifying a brand name, the pharmacy will fill it with whatever methylphenidate ER is available.

It's only if the doctor writes "Concerta" specifically that the pharmacist wouldn't make the substitution.

dag nab it
02-15-15, 04:05 PM
Update: When we filled my son's script for extended release methylphenidate (Concerta generic) in January, we were not given the Mallinckrodt that we had received at end December. It was filled with the Watson/Actavis "Alza", as usual.

Although my son said there was no difference on Mallinckrodt, at report card conferences, his first period science teacher said he had changed and did not seem as interested in the subject as before. [His other classes seem OK.] It could be that the Mallinckrodt was slower to reach efficacy. He generally takes his dose around 6:15 a.m. and his first period is underway by 8:30 a.m. You would think the medication would be working after 2 hours - but perhaps it was not.

At any rate, he's back on the authorized generic again.