We Did It! Concerta Generics on FDA MedWatch List

FDA Medwatch Concerta

To all ADHD Roller Coaster blog readers who took the time to complete the FDA’s complaint form after experiencing adverse effects from the new  Concerta generics: Good job! You have helped to place these generics on the FDA’s MedWatch List, as of April 21, 2014.

But this is an incremental victory, so we should stay vigilant and continue to advocate on this issue. A response from Mallinckrodt to my query, below.

You can continue reading the report below. But know this is a never-ending saga. You’ll find the latest update here:  Update on Generic Concerta.

FDA Report Says:

Citing “Lack of therapeutic effect, possibly related to product quality issues,” the FDA report goes on to say:

The appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but does not mean that FDA has identified a causal relationship between the drug and the listed risk. If after further evaluation the FDA determines that the drug is associated with the risk, it may take a variety of actions including requiring changes to the labeling of the drug, requiring development of a Risk Evaluation and Mitigation Strategy (REMS), or gathering additional data to better characterize the risk.

FDA wants to emphasize that the listing of a drug and a potential safety issue on this Web site does not mean that FDA is suggesting prescribers should not prescribe the drug or that patients taking the drug should stop taking the medication. Patients who have questions about their use of the identified drug should contact their health care provider. FDA will complete its evaluation of each potential signal/new safety information and issue additional public communications as appropriate.

The trouble with the advice to contact your healthcare provider is that most seem to have no idea that generics generally are problematic for ADHD medications and specifically that Concerta generics are highly problematic.

Unfortunately, the same is true for many pharmacists and pharmacies, which have vested interest in carrying these generics: They are more profitable.

More About Concerta Generics:

  • If you are confused about the difference between Concerta’s “authorized” generic (from Janssen-McNeil/Actavis/Watson) and the “true” generics (Mallinckrodt, Kremers-Urban, etc.), please refer to my last recap on the topic.
  • The FDA decision was based on data gathered during the last 3 months of 2013. No doubt the data has continued to amass. Please: This is important. If you or your loved one has experienced adverse side effects on the “true” generics, please file a MedWatch complaint (scroll down to “consumer”) here.
  • I salute Kristen Stuppy, MD, who also wrote about this issue at the Pediatric Partners blog here and here, and encouraged her readers to file complaints of their adverse reactions with the Concerta generics.
  • Stay tuned! And please share this post with your ADHD communities. Most people who write to me say they at first misattributed the side effects to other causes. Without doubt, many other people are experiencing this currently and should be informed.
  • ADHD med wonks will want to continue reading as I share my original e-mail to generic-manufacturer Mallinckrodt and its response.

My Letter to Generic Manufacturer Mallinckrodt

Here is my initial e-mail (in blue), followed by the spokesperson’s response (in red):

July 16, 2013

Thanks for taking my call.

To follow up, I’ve been receiving e-mail from readers, asking about the new generic of Concerta, a very popular sustained-release medication for the treatment of AD/HD in children, adolescents, and adults.

[advertising; not endorsement] [advertising; not endorsement]

At first, there was confusion due to the marketing agreement that allowed Watson to distribute the brand Concerta as a generic. Then I started hearing other reports about the non-Alza Concerta “generic” with an “M” marking and the horrible outcomes users were experiencing.

This blog post (one of several on generic medications for ADHD) talks about the Watson-marketed generic-brand. But there are several comments to it from readers about the Mallinckrodt “generic” (I’ve excerpted two at the bottom of this e-mail):


I am updating my blog with information on your company’s “generic”—which seems a cynical manipulation of FDA guidelines. (I cannot even be sure it is meeting guidelines.)  

The mechanism that made Concerta such a great choice for many people with ADHD is the OROS osmotic-pump, which delivers the methylphenidate in a steady rate, as the capsule passes through the GI system.

What the Mallinckrodt “generic” does is in no way similar. It is little more than a generic Ritalin or Ritalin LA.

The modern delivery systems for the neurostimulant medications (as in Concerta, the pro-drug Vyvanse, and even the patch Daytrana) have made all the difference in effectiveness and adherence. What Mallinckrodt, with this “generic,” threatens to do is turn back the clock and set up a situation where insurance companies will deny the brand name in favor of this shoddy substitution, which is both cheaper to insurance companies and more profitable to pharmacies.

The people affected by ADHD who read my blog are the vast minority in knowing this duplicity is happening. Many new to the medication have no idea that the results they are receiving from the M “generic” are substandard. I fear they will give up on treatment altogether due to the adverse reactions from this medication. They will not know there are better options and that this truly is no substitute for brand.

Those who have been taking Concerta for a while are attributing the new problems to other causes, not realizing that their pharmacy has substituted an inferior substitute. When they do realize it, their pharmacy assures them (wrongly) that it is equivalent.

Why couldn’t Mallinckrodt just offer this inferior “generic” as a Ritalin substitute? Is it because the Concerta market is more lucrative and your marketing department knows how to manipulate the system as well as your medical department has manipulated FDA guidelines?

But I promise you. The ADHD community will not take this without a fight. The stakes are too high. And I would not be surprised to hear of lawsuits issuing from car accidents, school expulsions, job losses, and more.

Here are some comments from the blog; I have received more via e-mail but am not at liberty to share those:

Generic User Feedback #1

My son is 6 almost 7 and has been on Concerta for almost 2 years. We have always received the Alza 36 mg pills (Watson brand) until last month. I took his script to Rite Aid and received the Mallinckrodt pill that has M with a square around it and 36. My son’s behavior was out of control, almost like he hadn’t taken any medicine at all. It was an immediate change that everyone including his teachers noticed.

The doctors and pharmacist tried to say they are exactly the same, but this month I made sure he had the Alza 36 (Watson brand) and he is back to normal and the outbursts and behavior issues have stopped. What I am having trouble doing now is actually finding a pharmacy that is still carrying the Alza 36 (Watson brand) When I call and request the Watson brand I’m treated like a criminal or an addict like I am trying to hunt down the drug for myself. But just know that there is a HUGE difference between the Watson and Mallinckrodt brand!!!

Generic Reader Feedback #2

I am thirty-nine years old and I take Methylphenidate ER 36 mg.  I just came from the Urgent Care clinic, EKGs, Blood Tests, Hypotension tests…

 I said to the doctor, “you know that feeling you get when you just want something salty, like sour cream and onion chips.  That’s how I think about Concerta.  I just want the Concerta.”  

I’m a pretty tough dude (not motorcycle but 1940′s dad-type tough).  I’ve been taking this crap against my better judgment for a few months.  There’s a night and day difference between the ALZA stamp and the other.  I keep my old bottles, for what had been, no apparent reason.  I’ve been searching the internet all day and just lucked into your site.  

I looked at the new bottles, MalinKRAP.  When I get the generic from Watson, which I now know is brand, I feel great and know that I made the right decision to go back to school, that I could be anything that I want to be.  On MalinKrap, I am dizzy, irritable, aggressive, hostile, faint, light-headed, cold sensitive, tired and I just feel defeated.

I used to take Ritalin when I was a kid and my mother said it worked but she felt it had too strong an effect on my personality so she stopped it.  I consistently scored higher on tests than my peers but never turned in any homework.  As a result, I have had a life full of great experiences that unfortunately didn’t include success in academics.

 In January, prior to enrolling in Community College, I saw a psychiatrist and was prescribed Concerta (generic)  and luckily, I received the Watson Lab version.  During those months I felt like nothing could stop me.  Not only was I doing well in school but also in relationships and the rest of my life.  

Then I was given the other.  I have felt worse these past few months than I can remember.  It is not just the side effects of the generic but the realization that something is terribly wrong.  I haven’t told anybody or done anything about it until today when I went to the clinic. I am so happy to read your posts. I don’t feel better physically (side effects) but mentally—there’s hope again.  Now I know the problem.  Everything you people are saying fits with my experience.

THANK YOU SO MUCH, GINA! Also, I’m 39 and it is hard for an adult to figure all of this out from the third person perspective. I feel so bad thinking of all the kids who don’t have the knowledge, confidence to stand up for themselves, and awareness that something is not normal.

I applaud you for fighting for us all.

Generic Manufacturer Mallinckrodt’s Response:

The U.S. Food and Drug Administration (FDA) defines generic drug as follows: “A generic drug is the same as a brand name drug in dosage, safety, strength, how it is taken, quality, performance, and intended use.” (See http://is.gd/2INMMj ).  Some patients may respond differently to a generic drug than the brand name drug. Patient variability is true for all drugs, both branded and generic, across all manufacturers.  
In late December 2012, Mallinckrodt launched its methylphenidate hydrochloride extended-release (ER) tablets as the first cost-effective, truly generic alternative to Concerta®, which was first approved in August 2000. Mallinckrodt’s formulation (a) has the same extended-release pharmacokinetic profile as Concerta; and (b) is AB-rated to (i.e., therapeutically equivalent to or substitutable for) Concerta because it met or exceeded all the FDA regulatory approval requirements (See http://is.gd/vBdMTE <http://is.gd/vBdMTE> ). Mallinckrodt’s methylphenidate ER utilizes a technology that is different from OROS.  
We believe that the Mallinckrodt generic drug is a safe and effective alternative for most patients taking Concerta.  Those patients who believe they are experiencing less effective therapeutic benefit with the Mallinckrodt generic product or who experience undesirable side effects should discuss possible alternatives with their health care provider.
Patients or their parents should discuss concerns regarding any medications with their physicians. We appreciate your efforts to help educate others as needed. 

If you’d like to tell Mallinckrodt President and CEO Mark Trudeau and the Board of Directors exactly what you think of his company’s version of Concerta, you can use this form.

Gina Pera

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