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.
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):
https://adhdrollercoaster.org/the-basics/whats-up-with-generic-concerta
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
I’m always late to the party but this just happened to me. I got the equivalent until this past month at CVS in San Antonio. I didn’t notice until I got home and started to fill m weekly medication box and the pills were round. After taking them a few days I called CVS and complained and they said the Oros Actavis generics were discontinued. I thought that was bs immediately and started researching and found this site. I called HEB pharmacy and they said they had the correct ones so I’ll see on 12/3/17. The makers of this other bs should be tried and hung!
hi again, Steve,
That was one party no one wanted to be invited to! 🙂
It’s not your fault that you didn’t know about this. It’s the pharmacy’s fault for pulling a fast one — they could have at least told you that you were getting a different version. But instead too many of these pharmacists perpetuate this harmful lie that generics are EXACTLY THE SAME as brand. They are not. As I’ve written about for years.
A Kansas City pediatrician and I led the charge to downgrade these generics (Mallinckrodt and Kremers-Urban). I called the FDA and asked how to go about it, and the woman I talked with was very helpful. Readers followed through with completing tedious forms.
Now, I understand that two more generics of Concerta are on the market. I haven’t heard first-hand reports as to how well they work. It will be very difficult, though, to simulate the novel delivery system of OROS.
The marketing agreement between the Concerta manufacturer Janssen and Actavis expires at the end of this year. I have a Google alert set for any news on any extension of the agreement. Nothing so far.
cheers,
g
This is great but my daughter has been taking the generic Concerta produced by Actavis which is produced by Janssen Pharmaceuticals who also produces Concerta and hasn’t experienced any problems. Also in November 2014 the FDA confirmed the generic marketed by Actavis is idential to Janssen’s Concerta. But as of January 2015 BCBS has changed the classification for ALL generic brands including Actavis and now instead of paying $10 per month for my daughter’s medicine I now have to pay $126 a month. For those of you who suffer from ADHD or have children who suffer from ADHD you know how difficult it is to find a drug that works with minimal side affects. After my daughter successfully taking the generic for concerta for the past two years.
Hi Dianne,
Yes, I’ve written several posts about that, including that Actavis is the brand, marketed as a generic through a marketing agreement.
I’m not sure what you mean about the FDA announcement of Nov. 2014, confirming that the Actavis generic is identical to Janssen’s. We’ve always known this. It’s an “authorized generic,” meaning it is the brand. The only difference is the name under which it’s marketed and sold.
Unfortunately, the change you mention with BCBS is one we’ve sort of been expecting. With these cheap generics now downgraded, insurance companies are re-negotiating with Rx providers. We hope this will settle down soon.
If that cost is prohibitive for you, and you qualify financially, you might be able to sign up for the patient assistant program. Check here: For information on free or discounted prescription medications, visit access2wellness.com or call 866-317-2775.
best,
Gina
Hi Dianne,
Thanks for reporting in!
Yes, the shifting marketplace is still wreaking havoc for Concerta users. (And really anyone taking medication, as it’s this time of year when insurance companies change their formularies.)
I’ll be updating with a blog post soon.
best,
Gina
I just brought a script for generic concerta to one of the outpatient pharmacies at University of Pennsylvania Health system and it was filled with the authorized generic – the Watson OROS one. CVS was filling it with the K-U generic. So if anyone in the Philadelphia area needs the real deal, go to a U of P outpatient pharmacy. Cost me my lowest co pay.
Thanks for the tip, Mike!
Hi Mike,
If that CVS was filling the generic with KU, I’m pretty sure that’s a violation.
But that’s a great tip about the UP pharmacy. Thanks!
g
When I went to Walmart to refill my script, they gave me this generic crap. Everyday I take it, I end up regretting it. I am still scattered like a flipping crazy. It is NO GOOD, plus my stomach was upset all day and it gave me acid reflux. I am lactose intolerant and have to be gluten free, what the heck did they add to it. One pill & the difference is already SO VERY obvious, a week and I am pissed! I have a hard enough time getting through a day, I don’t need this crap adding to it. ADHD ain’t not game and is bad enough!
I just went to my CVS to pick up my Concerta prescription and they gave me “methylphenidate er” by kremers urban. Attached to my paperwork was a paper with drug information for CONCERTA (!). I went back to them and complained that this was NOT the proper generic as it has a different release system and ask to be given either the original or the proper generic. She told me that eventhough my doctor wrote a prescription for “Concerta” because he didn’t write on the prescription “dispense as written” they must, by law, give me the generic and this is the only one they carry (!!!!!!) I said “this isn’t aspirin! how dare you give me a generic that is not the same exact thing and risk potential problems? if you don’t carry it then you should have informed me so I can go elsewhere, or tell my doctor to fix it!!” She said it was FDA approved so they don’t have to inform me. At the end she refunded me my money and gave me back my prescription. I will go else where. CVS just lost a long term customer. How can FDA call this a “generic” when the medicine is not the same exact thing??? How can this be legal??
Good question, Mufi — how can this be legal?
When I called a pharmaceutical-patent attorney to question how this could happen, he started off by saying, ‘No, it’s not illegal. It’s actually quite brilliant.”
“Quite brilliant if you are a sociopath,” I said. And I mean it still.
This MUST stop.
Please file your complaint with the FDA MedWatch link I provided.
Best,
g
Hi,
Just read this thread. My 22 year old son has been getting Watkins version of 54 mg Concerta (both brand and generic) at Walgreens for years and it is wonderful. We filled at CVS for the first time and got the Kremers version. Wow…huge difference. My son is crabby at first, then okay, then not, then okay, then not. Basically the stuff doesn’t work. Gives him headaches too. We noticed the shift in behavior BEFORE we noticed the different manufacture. Never again. Wish I could take this stuff back! J
Hi Jules,
I wish you could take it back, too, if only to register a tangible protest with CVS. What a racket.
best,
g
I got a true generic from Mallinckrodt in May of 2013. I have anxiety already, and not only did this increase my anxiety, but I had several other side effects that were physiological. I have been taking Concerta since I was a freshman in high school. As of now, I’m in college, and doing okay. I’ve had to work extremely hard to get the Watson / Actavis brand, which isn’t right.
I live in a different state than I go to school in, and my pharmacy at home was great with ordering Watson brand, as was my pharmacy in my college town until it closed. As of now I go to two different pharmacies because one has a contract that will not allow them to order anything else but the true generic Concerta. Luckily, my other pharmacy in town will.
My psychiatrist wasn’t aware of the problem until I brought it up to him last year…he didn’t even know a generic was made by Mallinckrodt. He has to write in the instructions OROS only, and no substitution, but I still need to point out to the pharmacist that it says that, otherwise I run the risk of getting true generic since many techs do not understand what OROS means (in my experience – not everywhere I’m sure).
I filed a complaint with the FDA, and Mallinckrodt contacted me (I checked the box that said it was okay if the company contacted me, no privacy was violated). They simply asked for the lot number and what side effects I had. I gave them the lot number, I gave the FDA the lot number, and they called my pharmacy to confirm the lot number. The lot number was correct (and verified by three sources), but I got a letter about a week later saying they closed my investigation because they didn’t have a lot number.
I don’t know what they’re doing over there, but it’s not right. They had my information and the lot number and they closed my case because they “didn’t have enough information to proceed”. They just don’t care in my opinion. They’re trying to make this situation go away by making excuses, and that infuriates me to no end.
Thank you, Emily, for reporting your experience.
Sounds like stalling to me, looking to individual lot numbers when we know the very premise of this generic is problematic. Perhaps that is the first stage of investigation, though, to see if other complaints are tied to that lot number.
Still, I wonder if the case is actually closed or if it is being added to the group of other complaints.
I wonder what step to take next: an open letter to the management at Mallinckrodt? I could post that, share on Twitter, etc. Maybe I could consolidate all the posts from readers who’ve had experiences similar to yours. Might create some agitation….
g
Any update on this? I was switched from the oros to the kremers urban and I just don’t find it works as effectively and I would like to take this to my doctor, but I want as much behind me as possible. Thanks
Hi Caleb,
The existing information should leave you sufficiently equipped to talk with your doc and ask about stipulating brand or the OROS generic.
good luck,
g
Hello, after reading through the posts, and making a comment I went back clicked on the link to share my experience with Mark Trudeau, the President and CEO, I am sure that I will not get a response, but I thought I would share what I expressed in my email.
Hello, my name is Barbara. I am a 47 year old female, I have two children 25 and 21 and I have been married for 27 years. I went back to college in 2007 and graduated with a Bachelor’s Degree in Theology with a minor in Psychology.
I overcame many challenges to earn my degree, but I graduated in December of 2012 and went directly into graduate school in January 2013. In December after I graduated I was tested for a learning disability, I refused to believe the directors or professors during undergrad that I would not nor could not be successful in meeting the requirements to graduate, specifically the foreign language requirement.
As a result my doctor diagnosed me with adult ADHD, and placed me on Concerta. Since that time, I have been taking a generic form of the medication and have encountered more difficulties than ever. Since that time the quality of my personal, professional and academic life have drastically deteriorated. I am currently on a medical stop out from school and in jeopardy being dropped from the program if I cannot return for the spring semester.
I have been asking and trying to find out if I was on the right medication and have been very concerned about the side effects. I received a notice from my insurance company early in 2014 that the coverage for Concerta was in review and may no longer be available.
After I had been on the medication for some time, I found that my concerns were not without merit. My insurance carrier notified me that they would only cover the name brand Concerta. I have been relentless in trying to identify what was going on, and questioning my medication. At my last appointment my physician said rather than guessing and changing any medication, we should do a DNA test to check and see what medications may or may not metabolize correctly in my system.
I am still awaiting the results, but after exhaustive research I found that the generic Concerta has been placed on the FDA watch list and many, many people have suffered the ill effects connected (although stated not conclusively) with the generic brand.
I have an appointment with my doctor tomorrow and will discuss my concerns, and specifically why I would be placed on a medication in the generic form that is under investigation.
The pharmaceutical industry seems to be more concerned about net profits than using the proper resources to help families and individuals who will ultimately suffer the consequences of defective products in exchange for the financial gain of the manufacturer.
I do not expect that my email will be recognized nor will I be viewed as an individual who only wants to be the “best me” that I can be for my family, my community and myself.
I am just a consumer lost within the potential profit for the manufacturer.
However, my name is: Barbara, with a husband who loves me unconditionally and two wonderful children, I am “someone” to my husband and my family, not just collateral damage to a potentially defective generic drug.
Thank You.
I had a horrendous experience taking the Mallinkrodt methylphenidate ER. I took one 27 mg pill at 8 am and it did not wear off until midnight. I was definitely absorbing more medication than I was supposed to. I was extremely anxious, my head felt like it was stuffed into a small box, and I was extremely irritable. I had to take 2 Ativan to take off the edge, and that barely worked.
I have taken Mallinkrodt immediate release pills for several years with no ill effect. I was prescribed Concerta because I had trouble remembering to take my afternoon dose.
In month 1 of the change I received 18 mg of Actavis generic, and had no ill effects other than that its strength was inadequate to be effective. In month 2 my prescription was raised to 27 mg, which more closely approximated the 2 doses of immediate release that I had been taking. I received the Mallinkrodt 27 mg and experienced the side effects described above.
The following day I took 2, 18 mg of the Actavis that were left over from my first month’s prescription. I had no adverse effects whatsoever. I felt normal.
That evening, I filed a Medwatch report describing my experience, and the following day I filed a report with Mallinkrodt, explaining that I felt that the pill contained more than 27 mg of methylphenidate, and the extended length of absorption.
My physician wrote a prescription for 27 mg of the Actavis generic only and the pharmacist is ordering it for me. Of course, now I have to do the dance with the insurance company to get a quantity exception for the month, which is difficult since it is a controlled substance. I will pay the $186 for a 30 day supply if necessary. It’s too bad that I can’t exchange simply them.
I am wondering if contacting the DEA about the issues would have any effect, since they control the amount of raw materials allotted to the manufacturer and I believe that they are able to inspect for quality as well.
This is a situation that must be remedied. I can’t imagine dispensing this formulation to a child after my experience. I suspect that some of the behavioural problems described, especially irritability could result from an overdose of medication rather than too little. How could they possibly communicate their experience effectively, especially if they are under 10?
Thank you, Beth! Especially thanks for filing a MedWatch complaint.
Sure, contact the DEA, too, but I’m wondering it we should mount a campaign with the congressional committee on FDA oversight (assuming there is one). Senator Chuck Grassley (R-NE) grandstanded shamefully against psychiatric research and medication a few years ago. I wonder if he’s still the “point person.” I seemed to be the only journalist who discovered that one of his top three campaign donors was Blue Shield (which of course does not want to pay for these psychiatric medications).
I just read your blog and it made me curious. My sons behavior started getting really bad near the end of the school year and at daycare all throughout the summer. He has been super aggressive and mean to other kids and teachers. I just started going through all my Rx receipts and guess what…Mallinckrodt was the new manufacturer for my 9yr old sons methylphenidate HCL ER 54 mg starting in June! I thought I was losing my mind, more importantly I thought he was losing his. Hopefully now I can get him back on the right track! Thanks so much, I will be sharing!
Hi Suzanne,
I am so glad to hear that my blog helped you to figure it out! Poor kid! Poor mom! Poor teachers!
g
Right on Gina, one again you are leading the way. I’ve been skeptical about Mcrap generic when I saw it was not OROS-based. How can it possibly be “the same”? Not sure how they could show even within the FDA rules how it is close to pharmacologically equivalent. If I could find a PharmD who didn’t work for a Big Pharma company, I’d ask him/her to review the data from studies Mcrap submitted, as well as the nature of the binders in it. Probably way too many variables to determine how the fillers affect absorption etc. In the end it comes down to $$$. Insurance companies win. …
Which brings up an interesting point – insurance companies have larger “reserves” (sic) than [name any bank, including the Federal Reserve], wonder how much of those funds are invested in Pharma companies? In pharmacy chains?
I spoke to one of the docs working for an insurer (amazing they had one, much less that I could actually talk to him in person) and after explaining why a patient needed a certain med, he said he understood the point, and would approve it “but I can’t do this too often, they keep close watch on me. I can bury it somewhere. ” At least he was honest with me, but what kind of crap is that? Corporate censorship of medical practice!
The whole “generic game” has gotten crazy in the past 6 months. Certain dosages of Focalin are generic, but the commonly used ones are still brand-only. Adderall XR generic is often more expensive than brand, even paying cash! One insurer denies coverage for Methylphenidate ER 18mg (generic Concerta) saying that Brand Concerta is a formulary option. At least they get their part of it right, but the pharmacy won’t put the rx in as Brand because I signed the rx on the Substitution Permitted side. Hmmm. “PERMITTED” does not mean “Required” does it? So the patient and I get triangulated between insurance Co and pharmacy, takes me another letter/appeal and a few weeks to response, meanwhile patient is inadequately treated. Same company has in the letter to me about initial denial “you have the right to speak to a pharmacist about this decision, call 000-222-3333”. Which turns out to be the main number for everything, not a direct line, and the clerk answering has no idea how to find a pharmacist. I went to medical school for this? I worked 100 hr weeks during residency getting paid $2.50/hr* to have to deal with this crap to get appropriate care for my patient? [$11,000 per year 1976-77]
I don’t think anyone in corporations, employers, HR depts, insurers, much less the general public (and least of all The New York Times) really understands the impact of ADHD on a person’s life. They focus on cost of meds, dangers (sic) of meds, increasing use of meds, but know nothing of the risks/costs of untreated ADHD, nor the reality of dealing with ADHD on a daily basis. THAT is what we (the ADHD aware community) have to get across. We have to try to put our energies into winning the battle, not the skirmishes along the way.
One battle at a time, and we may win the war. All it would take is for one Senator’s kid to have ADHD, and one insurance company CEO’s daughter to have a kid with ADHD, and more would happen in 2 months than in the past 5 years. Maybe we could come up with a reality TV show, “Try dealing with this kid for a week” . Or find a drug that scrambles the pre-frontal cortex for a few days. Oh yeah, I forgot. They just legalized it in WA and CO…
So if the Aetna executive dining room got some special brownies. …
Pardon my rambles, and rants. Too damn much to rant about.
Dr. Dave
Right on, Dr. Dave!!
My pharmacist has her doctorate. Is that what you mean?
Thanks for writing about this! I found a pharmacy (Walgreens) that carries the Watson form. I picked it up this evening. If it wasn’t for this site I would have never known. My 15 year old just started on this last week…She said “maybe it helps…” So now that we have the real stuff, hopefully she will see a definite difference. We’ll find out tomorrow.
Gina, this is a rampant problem with generics, and with some, the effect is much worse than with others. Psychiatric medications especially should be IDENTICAL, because the effects of the differences can be devastating. I take Adderall, but have the same problem. Adderall is 23% levoamphetamine as part of the amphetamine salts, but generic is 100% dextroamphetamine, which makes it an entirely different drug, *not* a generic equivalent.
The FDA’s standards for generics need to be much tighter, and insurance companies should not be overruling our doctors recommendations by giving us different medicines than the ones we need.
Yes, a long-running problem, Alison. I wrote about it on my blog first when Consumer Reports said that generics were best for ADHD. Search my blog for generics, and I think you’ll find a few more, too.
Hey Tom, Welcome to the roller coaster! I’m glad your first visit proved useful!
Your wife’s doctor is wrong, sorry to say.
If she’s getting the OROS generic, she’s good. Maybe the others would work okay for her, but she should be cautious and know that it could go very wrong.
g
Pharmacies where I live tell me that they are required to give the generic unless the PRESCRIBER indicates on the script “brand”. I tried to argue the point but they persisted. Already out that meant that I had to wait until the next day to go across town, get a new prescription written and then back to the pharmacy that night. I did find that it didn’t make much difference, though. for the past year I’ve found pretty much any of the usual drugs don’t help me one bit. Even when I was first put on Adderall XR (generic of course) it only helped a little in some areas, but kept my excess daytime sleepiness at bay. Then that stopped – and I found they switched suppliers – and since that I’ve tried Concerta (gen), Ritalin (generic), Dexi-something, and back to generical Adderall but about to give up as it seems these things just pass right on through without even pausing on their way back out. Makes me wonder if my body simply can’t metabolize these things?
But back on the generic vs. “Brand” – it’s not just the active ingredients and how they work, it’s the inert or other ingredients that can cause us issues! We react differently to the drug itself – but also to what it’s combined with, how it releases and so on. There are as many possible outcomes with a drug as there are people – then toss in all the possible generic combinations and the “other stuff” they put in that pill or capsule and like my provider and I have discussed – it’s one life-long experiment!
Hi Bill,
Yes, I think it’s true in most if not all states that in order to get the brand, the MD needs to indicate “do not substitute.”
Absolutely, it’s the other ingredients in generics that can cause problems, too. I’ve written about that. Binders. Colorants. Even gluten for the gluten-sensitive.
Again, there are many questions to ask about why you don’t seem to receive benefit from the stimulant (and you don’t have side effects, either?).
If you are sleep-deprived, for example, no stimulant will help with that. (That includes being “good-sleep”-deprived.)
If you are suffering from undetected allergies and sensitivities (to food, pollen, etc.), a stimulant might actually help with some allergies but not overall.
If you are a high-metabolizer, you will need a much higher-than-average dose.
Many possibilities.
It would be great if you could try some brands. If cost is a factor, inquire with the companies about their patient-assistance programs. Each brand Rx has one.
Good luck,
Gina
I’m very happy that those generics are on the FDA watch list, hopefully more people keep filing their complaints, I did and I got a letter from K-U requesting more information.
I wanted to know if anybody reading this blog had any luck finding a pharmacy that still carries the Watson generic, I live in northern New Jersey and so far I can’t find one pharmacy that has it, I’m been paying for brand name because my insurance (Cigna) denied me the request to consider Concerta as a “preferred brand” for medical reasons.
It’s so infuriating to see how this system is there just to make more and more money to the pharmaceuticals,pharmacies and insurance companies, I feel so cheated as a consumer.
I don’t blame you for feeling cheated.
You might want to drop a note to those stores and tell them why you won’t be shopping there for other consumer goods, either: Because they’re putting their profits ahead of your and your family’s physical welfare.
I would see if your insurance policy includes a mail-order pharmacy benefit. Those fulfillment companies are so large, they don’t typically experience the same supply issues as the storefronts.
Good luck!
g
My daughter started on Concerta when she was in 3rd grade-two years ago and within an hour it was like someone had flipped a switch and she was connected to the world. By that summer things were not working well-she was defiant, aggressive etc. -we chalked it up to all kinds of other reasons-upped the dose/reduced the dose added an anti depressant, took parenting classes and therapy-things are better but still not right-after seeing a link to this on an ADHD Facebook page -I went to the cupboard-yep what I thought was Concerta is the “true” generic by Mallinckrodt, which would have been put on the market about the time we noticed the change in the effectiveness of our daughter’s meds. It could be coincidence and then again it could be the drug change. I will be calling her Dr. and our Pharmacy on Monday and so help me if it turns out this drug company has been messing with my daughter’s well being to save a buck-I’ll be writing everyone and consulting a lawyer.
Go Cara!
Multiply your family’s story by ???? and I am gobsmacked at the recklessness displayed by all concerned, but especially Mallinckrodt and the pharmacists who don’t warn customers of this. Talk about a conflict of interest!
g
I am one of those parents who is new to this whole thing. Stunned to read this. Had to fight my husband to finally let my 7 year old son start on the meds. We have been discouraged that they appear to wear off by midday, and upped his dose. He was on the K brand at 18 mg, now on the 27 mg M brand. He is moody and famished by the evening. Bursts into tears for no reason. We were debating giving up (is half a day of focus during school worth the battles with hubby at home?) when I read this. We are only two weeks into the month, but I am going to find out which pharmacies carry the Watson brand. Seriously, it took 3 years of work to convince myself and my husband that it is not a parenting failure that our son needs meds – and then they didn’t appear to be working!
Hi Krista,
I’ve taken the time to report on this issue precisely because of people such as you, your husband, and your son. And I’m so glad you found the information helpful.
It is HUGE decision to decide to give a child medication for ADHD. And it is extremely important that the medication trial be well-done. Otherwise, you won’t know what is the medication, what is the co-existing condition that it might have provoked, what is the generic’s “binders, fillers, and colorants,” and so forth. Too many variables.
It could well be that your son, like 50 percent of people with ADHD, has a co-existing condition. These include anxiety and depression — “serotonin issues” that can be exacerbated by the stimulants, which target primarily dopamine. If that is the case, stimulants alone can increase irritability and sleeplessness. So, it’s good to narrow down the potential for side effects that might be mistaken for these issues.
Some people have no choice but to use the generics, and sometimes that’s okay (certainly better than nothing). But in the beginning, before it’s established which medication at what dosage is most effective, it’s just foolhardy to add the extra variables of generics if one can help it.
Best of luck and kudos for being pro-active in your research!
Gina
The saddest part is that newly diagnosed people that are prescribed Concerta but get generic Mallinckrodt may never have a positive response to medication unless their Dr. is aware of this generic substitute and really treats enough ADD patients to see the actual results when patients suddenly get the switch. And get better when they go back on Watson generic OROS.
That’s certainly one of the sad outcomes — and what I wrote to Mallinckrodt:
“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.
g
Thanks Gina, for keeping us all up to date on this. It has helped my DH to stay on the authorized generic, although it has taken some effort. He spent some time on the phone calling our authorized pharmacies. On our area CVS no longer offers the authorized generic, Walmart does. CVS was going to charge us more for the true generic! They did offer to fill the scrip for the same price as Walmart, DH of course turned them down.
Hi Laura,
Props to your husband for persevering through those phone calls!
g
Thank you so much for this post. Our insurance changed its policy this year about brand vs. generic and now brand isn’t just $20 a month more anymore. Basically, if there is a generic, brand is no longer covered for the older drugs. The newer ones at such that the cost of the generic actually exceeds $30. Since I’m already on brand for a couple drugs, I’m eligible for an exemption, or so we were told. I asked my psychiatrist to start prescribing me brand for Concerta last December instead of the Watson Authorized Generic. I’m glad I did. I was told to go to a website to get the exemption and when it didn’t exist, I was told to have my doctor send a letter to the insurance company. His first letter was denied citing I’m already paying the minimum copay and applied to last year. Also, despite the fact that two drugs were listed and he continued to alternate the order of their names, we never received a response about Concerta. When my husband picked up my medications for me, I had done the math and in January, it was most cost effective to split up the Concerta into two different doses instead of taking two 18mg pills for certain doses and one for the last dose. The insurance company only gave me the exemption for the 18mg Concerta, which is what switched “back” to brand in December. We ended up paying thousands of dollars for the 36mg strength and the other drug. When I called them again, I got a better rep and I said the dosing on my medications change a lot, so this exemption should not be dose specific. On their end I was getting the exemption and everyone had given us bad information. A supervisor found the website I was talking about and indeed it wasn’t there still. My insurance is a “self-paid” plan through my husband’s employer and the insurance company ended with me that they would have to contact the rep from the employer because based on how the policy was written, if my doctor requested the brand, not me (prescribed daw) it should be at the $30 copay level anyway. Pharmacies here won’t give you brand upon request although by law they are supposed to I guess. I always get my brand medications written daw. This took months to sort out, I did have a dose change in the meantime, and in the end I got my exemption for all strengths of both drugs but it took so much time and money. I had thought the dose of Concerta I really need right now (other drugs affect my metabolism of it and they change over time) didn’t work because I got the MallinCrap brand for the first time. On the brand, I’m doing great. My exemption is only for three years and this is likely a “for life” drug for me. If we get all the generics pulled from the market, this goes back on my insurance company’s formulary. I suspect this is the case with a lot of people. MallenCrap does not have OROS, which is what differentiates Concerta and I believe Alza’s patent has not expired. I told my doctor I believe it is the OROS system that makes the difference for me and I don’t buy the crap about this osmosis system being the same and why is half the publicly available monograph for the MallenCrap version redacted anyway? That’s a red flag for me. It was acting like Ritalin where I’d feel like I was high for an hour and then crash. OROS seems to be the only thing that makes Concerta actually work and it took over 10 years to find. I was on it well before any generics came out and had read this site before encountering the MallenCrap version so later on I was willing to try that dose again in brand and it works wonderfully. I think it is time to file a complaint now that I have an apples to apples comparison. Thanks for the info and keep up the good work! It will benefit everyone taking Concerta, especially the kids who really don’t know what is going on with parents who don’t know about delivery systems and transport mechanisms and binders and all the stuff they don’t tell you about… Generics are never the same and just look at the pump on real Afrin vs. the store brand for an example of an effective vs ineffective delivery system. The public is so misinformed by pharmacies, manufacturers and insurance companies about generics it disgusts me. Those who are severely lactose intolerant might benefit from this info because guess what is an “inactive” ingredient in quite a few medications. Please keep up the good work. We are being lied to again and again and need to know the truth.
Danielle
Hi Danielle,
So glad you found the information helpful!
I’m in a bit of a rush and not sure I followed all that accurately, but just want to make sure you know that the Watson product IS the brand.
best,
Gina
This was wonderful news and I hope that the FDA will get it off the shelves.
I wrote to Mallinckcrodt at the end of last year to address concerns our practice had regarding their product and the complaints and side effects we heard and saw in our patients who received their generic (even when we wrote for OROS delivery system only.) They did try to call me and then sent a letter asking that I send them a list including the patient’s name and their specific reaction and the details after taking the generic Concerta. Many patients already contacted MedWatch already, but there is no way we would have the time to review so many charts and write this up for them, let alone give any names. They never bothered to get back to us or follow up. The FDA did contact at least one of our patients who submitted to Medwatch though!
Hi Tag,
As with Aubrey receiving a call from M, I find it extremely creepy that they asked a doctor’s office for those patient names!! The reactions yes, but the names?????
This is outrageous!!!
Thanks,
g
Oh Penny, but you know how it is….parents of kids with ADHD just want to take the “easy way out.” 🙂
Hey, you might want to mosey over to the “Drugging of the American Boy” piece at Esquire and put in your two cents. 😉
http://www.esquire.com/features/drugging-of-the-american-boy-0414?fb_comment_id=fbc_507176742720880_2635494_507524589352762
g
I actually got a voice mail from Mallinckrodt the other day about my complaint that I put in with the FDA. I’ll be calling them in the morning because I got sidetracked and forgot about it.
Good news is that I finally found a pharmacy that carries the Watson version and have been doing a lot better than on the Mallinckrodt version. I will say the Army hospital pharmacy here even stopped carrying actual Concerta since Tricare switched over to the generic. The pharmacy stopped carrying the name brand 2 months ago and one of the Techs said she didn’t even know what OROS formulation even meant.
Hi Aubrey — ACK! Did you set the Army hospital straight? It would be great if you could print and send a copy of the FDA statement to them, to get it on the record. Complain to Tricare, too, if you can.
I’m glad you found a pharmacy with the real thing!
I think I’d be a little creeped out about M contacting me if I’d filed a complaint. I’m surprised there’s not some privacy.
Gina
Well it looks like my voice mail deleted itself lol so I don’t have the number. But yeah they called and it was a female saying she was with Mallinckrodt and that she wanted to talk to me about the complaint I filed with the FDA and wanted to discuss my concerns.
I have run into the issue with pharmacies (the one that is in the same building as my Psychiatrist, Target and the pharmacy on Post) pretty much argue with me that it’s the same exact medicine. I now go to CVS and am perfectly fine having to pay for it because it works for me. The Mallinckrodt version was wearing off within a few hours and I am taking 54mg. It would last 8 hours top and then it would make me severely hungry at like 4 in the afternoon. I also noticed that I was craving sugar a lot more too. Now that I’ve been on the Watson brand (which is the same exact pill as the Alza) I’ve been doing so much better and it last about 14-16 hours. I also am not craving sugar as much.
I wonder if they will attempt calling me again.
By the way thank you so much for your blog! I learned that I wasn’t the only one having issues with it. I brought it up to my old doc and she didn’t think much of it.
Congrats for being a pro-active patient, Aubrey. It’s a lot to ask of folks with ADHD, to have to jump through all the insurance and doctor hoops just to get the diagnosis and prescriptions, only to have to monitor medication efficacy as well! Geez!
I would LOVE to know what the M rep says to you, if you receive a call-back. I’m still appalled that they are given that information.
g
Can you tell me what name pharmacy carries the OROS form. I called mine and they said they CAN NOT get that form , they have to use whoever their distrubutor is (of course it’s the Mallinckrodt one…)
Thanks!
Hi Jenn,
It really depends on the locality, I think. These decisions don’t seem to be made on a nationwide basis.
I’ve heard that Walgreen’s is more likely than CVS to carry the OROS (Actavis/Watson “authorized generic”).
Otherwise, best to try your mail-order pharmacy, if your insurance offers that.
g
Thank you too! I have found your blog describing authorized vs true generics very helpful and have shared it often. It helps make sense of this mess. I’m excited to see this information and I agree that we need to keep filing reports. Thank you for all your work and follow up on this issue!
HELLO> FORM OF THE MALLINKRODT Methylphenidate ER which feels like A PLACEEBO or MY EYES ARE GLUED OPEN? WHAT AND WHY CAN’T I JUST STAY WITH MY REGULAR RITALIN ER chewing still makes the mallinkrodt er work the same way. 5-8 hrs. THIS IS GETTING REDICULOUS! Adult who can function better with adhd med.
Hi Gary,
You do NOT have to accept the Mallinckrodt generic.
It has been downgraded by the FDA (thanks to our efforts here at the ADHD Roller Coaster).
You have a right to the authorized generic — the brand sold as a generic.
Please find another pharmacy is that one is steering you wrong.
good luck,
g