What is the problem with the Concerta generics? (The ones recently downgraded by the FDA.)
What, exactly? That’s easy. These generics lacked the essential technology that makes Concerta, Concerta (the novel OROS osmotic pump).
Many medications contain the stimulant methylphenidate (MPH)—Concerta, Ritalin, Ritalin LA, Daytrana, Focalin (a variant of MPH), Metadate, Quillivant, etc. The difference is in how the MPH is delivered to the system.
My previous post highlights the technical details about these downgraded generics, along with some consumer tips for coping with the transition.
In this post, below, you will find a compilation of real stories from real people, via comments to my blog posts on this topic. They share their experiences with the Concerta “true generics.” As it turns out, they weren’t all that true to brand.
Before We Get to the Stories:
I invite the shareholders of the companies who manufactured and sold these inferior products to read these stories of lives going off the rails. Yes, these companies might have abided with the letter of FDA law, but the spirit? The ADHD experts I spoke with two years ago were aghast that these poor imitations of Concerta were even approved.
And what about the pharmacists? Could working for a drugstore chain present a conflict-of-interest? Generics are typically much more profitable than the brand and, in some cases, the authorized generic. When these pharmacists assure customers that generics are “the same as brand,” are they showing more allegiance to the store than the consumer? In other words, are they compromised or simply ignorant about the vagaries of “bioequivalence”?
Before getting to the first-person accounts from Concerta-generics consumers, let’s quickly review two issues following the downgrading:
1. Mallinckrodt Responds by Suing the FDA
We could anticipate that the downgraded-generics manufacturers, Mallinckrodt and Kudco, would not take the FDA actions lying down. After all, these companies are profit-driven.
Kudco has been mum on the subject. But Dublin, Ireland-based Mallinckrodt, which reportedly saw shares fall almost 7% on the news, responded to the FDA decision by immediately filing a lawsuit against the FDA.
President and CEO Mark Trudeau said this in a company press release:
We believe that the FDA’s actions are not supported by sound scientific evidence and not consistent with the best interests of patients….
…Mallinckrodt methylphenidate ER products have consistently met all quality specifications and the regulatory requirements originally defined by the FDA, and in the 21 months since launch more than 88 million doses of these products have been prescribed. In that time, and across all of those patient exposures, the company has received only 68 confirmed adverse events related to a lack of efficacy when the patient switched from the reference listed drug (Concerta) to the company’s methylphenidate ER products.
That 88-million-dose figure raises an important question. Of all the people dispensed this generic, how many actually knew that they were receiving a product inferior to the brand Concerta? A tiny fraction, perhaps. If consumers thought to question their pills’ different appearance, pharmacists often held with the party line that generics are “bioequivalent” to brand. Many prescribing physicians had no clue. Incredibly, many still don’t.
Moreover, there’s the changing nature of ADHD: Symptoms vary depending on the context in life (a new teacher, a new job, etc.). This leads many people to never suspect the medication they’ve been taking for a while, to good effect, has suddenly gone awry. As a result, they blame themselves or their situation.
Yes, they might notice that their pill looks different than the pill they’d been taking. But pharmacists and physicians assure them that generics are “the same as brand.” Why would they doubt it?
Only the stubborn few, it seems, kept digging until they found my blog and that of Kansas-based pediatrician Kristen Stuppy. And a few of them joined the effort to have the FDA look into this situation by tediously filing complaints with MedWatch. In short, I find Trudeau’s claims suspect, at best.
2. FDA Re-Evaluating Generic Standards
My first investigation into this unfolding story took place more than a year ago. I didn’t understand how these two companies could legally foist two inferior generics on a vulnerable public. So, I called a pharmaceutical patent attorney.
The conversation went like this:
Gina: Are these generic manufacturers acting legally? They don’t have the OROS technology. Yet, that’s what distinguishes Concerta from other methylphenidate products (Ritalin, Ritalin LA, etc.). The manufacturers haven’t demonstrated that the medication has the same drug-release profile as Concerta. So how can they claim bioequivalence?”
Pharmaceutical patent attorney: Yes, the companies have acted legally. In fact, what they’ve done is brilliant.
Gina [noting his utter lack of curiosity about the horrifying reports I was fielding from readers]: If you consider sociopathy brilliant.
This Concerta-generics case, coming a few years after a similar problem with a Wellbutrin generic, seems to have galvanized the FDA’s attention. It is currently shifting its stance on generics as always “bioequivalent.”
Now! For The First-Person Stories
As promised, here are stories of real-life experiences with these inferior generics. This is a curated compilation of reader comments to my various blog posts on Concerta generics, over the past two years.
These stories are organized into subgroups:
1. Adults who disclosed their profession
2. Other adults
3. Parents of children with ADHD
Thanks to all for your comments. Plus, again, a huge thank-you to those who completed the FDA MedWatch form. I am proud to have opened the MedWatch case. Yet, without consumers following through, it would have meant nothing.
From a mental-health professional:
Dear Gina, I’ve worked in the mental health profession for nearly the past 8 years in positions ranging from crisis intervention counselor, to inpatient psychiatric social worker in addition to internal employee assistance counselor. Kristen, and Gina, I cannot thank you enough for all the information and comments in regards to the Kremers Urban manufactured generic of Concerta.
My struggle with treating ADHD did not begin until I was an adult, and over the past 7 years or so I’ve taken the brand version of Concerta with much success. So much success, that it made the difference in being a C-B student as an undergraduate, to completing graduate school with a 3.54 GPA in 2.5 years, and a plethora of job opportunities post-graduation.
However, over the past couple of months I’ve had problems with impulsiveness, restlessness, short-term recall, procrastinating, lack of interest in learning new difficult subjects, and sustaining attention on familiar topics and conversation of interest, all problems I never had while on the brand for 7 years.
I had chalked much of my problems up to the fact that maybe I was experiencing some adjustment issues manifesting as increased depression and anxiety after a recent move from Southern California to the Midwest. However in all my years of behavioral health, I felt like I knew better and it had to be something deeper as I didn’t feel as focused as I was in the past. Even on good days while taking the Kremers Urban generic, I still feel like I’m experiencing that “zombie like state” so many have reported from Ritalin, so I started to think this can’t be me and it had to be the medication dosage.
After finally bringing up the issues to my new doctor (who I’ve only seen 4x), that maybe I had developed a tolerance for the medication and needed a higher dosage, he quickly labeled me as seeking a performance enhancement and cut me off to recommend we give it another month.
That “additional month” included two holidays, in addition to a 9 day vacation so all in all, it was hard for me to report back to him any continued difficulty I was experiencing. With the same script and dosage in hand, I was off to the pharmacy last week only to find they couldn’t fill my prescription because of a shortage of the generic methylphenidate ER, which prompted me to do some research on why.
Rather than accept an unwanted fate and spend another month struggling or attempting to journal about what’s not working, I’ll finally be back on an OROS starting tomorrow largely thanks to all the information I’ve found through your blog.
I can’t thank all of you enough for the work you’ve done up to this point, it feels so refreshing to know things will be a little easier again beginning tomorrow!
From a surgeon:
I feel like such the fool, as it has taken me almost 9 months to figure this out. By all appearances I should have been at the first wave of complaint. I am a physician, indeed a sub-specialty trained surgeon with a practice based upon tertiary-referral complexity level cases.
When I was first involuntarily switched to the Mallinckrodt generic, I thought I must call my prescribing physician to ask if any others had reported the remarkably irregular and apparently unpredictably “spastic” nature of the delivery of the drug! Soon this was overshadowed by a host of other complaints, of which I am hesitant to disclose, lest you think (as I thought) that I had turned into one of those “crocks” that simply reported YES to every possible symptom. (“Crock” as crazy patient with host of unreasonable and illogically connected complaints.)
One thing led to another, until by the grace of God I was finally compelled to see the prescribing physician, who casually reported the common knowledge of the poor quality and irregular delivery system of this “bio-equivalent”. I was still relatively suspicious of my “crock”-ness, but was happy to return to the previously steadily effective drug delivery that had offered me such steady support of function over many years.
The result is almost beyond description. As a physician-scientist, I know about the placebo effect. That said, the change in me has been dramatic, and this change occurred in TWO DAYS/doses!
Prior, on the generic, I could not even remember feeling good, and was beyond weary of not only my litany of complaints, but also of even ME. It was less than 2 weeks ago that I was writing my last will and testament, feeling that if my life was this and this only, it should end. NOW I AM BACK!
Over the past months, a challenging surgical case, which previously would have given me great joy in solving and overcoming its complex obstacles, became a series of searingly painful tortures I endured, praying that I could avoid harming the patient in the process.
After changing back to the brand on Wednesday, by today (Friday) I did a 6-hour grueling, complex, frustrating, and JOYFUL case. I did not regret being ME as I did it. I did not feel like anyone who endured ME in the process deserved an eternal crown of glory previously reserved for the martyrs. I am back!
I regret my absence, and regret the pain I know my presence has inflicted on others while I was fighting to return.
From a grad student:
I am a grad student, and have been on Concerta for a very long time.
After trying many different brands and doses, somewhere around 5th or 6th grade I was started on two 54mg Concerta capsules every day. This worked significantly better than other brands and doses. I have been on the exact same dosage since then (~12-13 years).
A few years ago I switched to the generic. It looked the same and I didn’t really notice a difference [Gina adds: The authorized generic is the same as brand, which is why this grad student saw they looked the same.] I had been warned by my doctor to avoid the generics, because there were various problems with them.
Today, I went to pick up my medicine from the pharmacy as usual. On my way back to campus (I was home for the weekend), I noticed that the pills looked different. At first I was concerned that they might have made a mistake.
I was wondering if anyone had any experience with the Kudco/Kremers-Urban generic Concerta.
Not much of a difference at first, but I feel more jittery than I used to, and I’m finding myself more distracted. (I’m here instead of studying for my last final.) I wouldn’t have minded trying a different manufacturer over the break, but a trial by fire in the middle of finals was not something I wanted.
From a teacher:
I had the same thing happen to me. I was concerned [about switching to a generic] but decided to see what happened if I took this generic instead. I noticed a marked increase in my impulsivity and my tolerance for stimulation lowered dramatically.
I am a teacher and it really started to cause problems for me, especially in the afternoon. It seemed to wear off more quickly.
My doctor was no help. She simply wrote, “time released” on the script, and the pharmacies told me all the generics were time released. I explained yes but not in the same way as Concerta. They weren’t interested and acted like their hands were tied; they have to prescribe whatever is sent by corporate.
I did find a local pharmacy that still has Alza [makers of the OROS technology that is central to Concerta; the name is printed on brand/authorized generic pills] and switched there. But they too said that they aren’t sure how long they will keep this type of generic.
One thing I started to do was to wait until lunch to take my medicine. This allowed the medicine to start kicking in during the most stressful part of my day. Good luck with this very frustrating change!
From various adults:
1. “It is like a caffeine high falling off a cliff.”
It is definitely not the same as the Concerta with the OROS release.
Six years I have used Concerta. I was prescribed the new generic and had to go back as well.
It hits you hard all early in the day and makes you jittery, and then you hit a wall and it is like a caffeine high falling off a cliff. I get to 3 or 4 pm and could pass out and nap anywhere. And I am not a napper.
2. “The pharmacists assured me that these generics were completely equivalent.”
A hearty congratulations from a victim of the false Concerta generics (on this post).
I had been using Concerta for over 5 years, usually paying around $200 per month (54 mg tablets), after insurance. When I would complain about the cost, several pharmacists recommended that I try the generic versions made by Mallinckrodt or Kudco/Kremers-Urban. These were much less expensive, but they were not effective for me at all.
On two separate occasions, I was stuck with a month’s supply of an almost useless drug. Yet the pharmacists would assure me that these generics were completely equivalent to the “real” Concerta.
3. “I am unfocused after 3 hours.”
I just picked up mine yesterday. They are pink and look totally different than the [authorized] generic version, which used to look exactly like the brand name ones.
At first I did some research and found out that this is NOT the same company behind the original generic Concerta [Watson/Actavis], which I have used and had no problems with.
This new version is NOT the same drug. It is crushable and does not have the same delivery system. I am prescribed two 36mgs in the morning, which normally would last all day or 7 hours max. Not now. I am unfocused after 3 hours and feel as if I am taking an IR form of Ritalin now, which is fact it basically is.
4. “This is the best news!”
This is the best news! Like many others, I stumbled across this website when I received my Concerta rx in the Spring that didn’t look like Concerta. It turned out to be manufactured by Mallinckrodt, and I subsequently filed a complaint with the FDA.
I’ve been on Concerta for 11+ years and it is the best drug therapeutically for me. But no matter what insurance company I’ve had over the years, this drug has caused numerous “headaches” —when it comes to cost, generic issues, or what have you.
It is so nice to feel like we finally got a win.
5. “Don’t be afraid to tell your doctor.”
I had to go back to my doctor and get at new script and junk the rest of the Kremers Urban medicine.
Kremers Urban should not be allowed to qualify as a substitute for Concerta.
The difference in effect is compelling enough to make me question how this drug made it through testing as a qualifying substitute for Concerta.
Don’t be afraid to tell your doctor. I was able to get my usual script and was able to work with my insurance to minimize the cost of the brand name I replaced the Kremers Urban garbage with.
1. “He is having problems with black spots in his vision, dizziness, headaches.”
So glad to have found all of these experiences. My son is 13 with ADHD. When we picked up the generic Concerta a few days ago, he noticed that it looked different from the previous generic.
I checked the bottle and decided that they must have switched manufacturers but told him to go ahead and take it.
With the Kremers pill, he is having problems with black spots in his vision, dizziness, headaches, & numbness in his fingers. Thankfully, our doctor is great and told us to discontinue for a few days to ensure the reaction goes away and can for sure be linked to the Kremers generic.
After that, she will make sure that we only get the brand name and will write the insurance if needed. It’s amazing to me that pharmaceutical companies can get away with subpar work such as this.
2. “For 4 straight days had a dizzy-headache effect at the 4-hour mark.”
My son has also been on a dosage of two 36mg Concerta tablets daily for more than a decade without incident.
In December, he got the Kremers Urban generic. For 4 straight days had a dizzy-headache effect at the 4-hour mark. He stopped taking the drug, returned to the pharmacy, notified his doctor, and reported the adverse effect to Kremers Urban and to the FDA.
It is only through reporting these issues to the FDA that a database on the issue can be maintained and the manufacturer is forced to dig deeper into the performance of his product. My son has returned to using only Concerta, which for him ends up being $490/month.
3. “I was not looking for problems.”
I was delighted to get the Mallinckrodt generic because I saved $80 on my co-pay. Then I tried it.
I was not looking for problems, but noticed a day in that the drug was not working as the Alza version did. Now I am working to get my pharmacist to switch his generics to the Watson version.
4. “We did not experience any of these problems with the Concerta.”
Four days ago, my pharmacy gave me a generic (Mallinckrodt ER 27mg) instead of Concerta for my 11 year old. It does not seem to be working, or working inconsistently. My child has become very forgetful, difficult to deal with and is unable to fall asleep at night. We did not experience any of these problems with the Concerta.
5. “It’s so hard to know if this is a blip in his treatment, if he needs a higher dosage or if it has to do with the generic.”
My 8 year old was on Concerta 18 mg for one month for ADHD. For the second month, the pharmacy gave me the generic and assured me I would see no difference.
Day 3 and 4 of the generic meds (after the weekend) and he’s having issues in school. Not getting along with friends, crying over spilled water, not having as much self-control, etc. It’s so hard to know if this is a blip in his treatment, if he needs a higher dosage or if it has to do with the generic.
6. “Now I need to find another medication. I hate to do that because Concerta works so well for him.”
I had the same problem with my 9-year-old boy. He was on Concerta and we tried the generic. He didn’t like it, said he could tell the difference and it didn’t work as well.
Now his insurance said they won’t cover anything other than the generic. Now I need to find another medication to put him on. I hate to do that because Concerta works so well for him.
7. “I am ANGRY at my pharmacy because it is their job to know these things.”
My son is 7 and was given the Kremers Urban generic Concerta. He started hurting himself.
His doctor and pharmacist agree it could be something in the medicine, a preservative he’s sensitive to. His therapist doesn’t understand how this generic Concerta is being seen as time release without the [OROS] capsule and that also may have played a factor. He’s getting too much at one time.
I am ANGRY at my pharmacy because it is their job to know these things. I was even told today that Actavis/Waton was no longer making the authorized generic available. I called another pharmacy and they have not heard. You really can’t trust companies. They will do anything they can to keep you and your money.
8. “He told me to PLEASE find the old medication.”
My son is 7th grade, gifted, A-student who has been doing well on Concerta brand and also the Watson [authorized] generic.
Last month our pharmacy switched to the Mallinckrodt manufactured brand and everything changed. His impulse control and focus issues were back with a vengeance. He noticed a marked difference in the effects of the medication throughout the day, and he told me to PLEASE find the old medication.
I’ve done some other research and according to the press release for the Mallinckrodt product, “the FDA found that our long-acting technology delivers a dose which is therapeutically equivalent to what is currently on the market.” I disagree completely with their statement.
9. I am having a hard time finding Concerta brand or the [authorized] generic from Watson.
I am having a hard time finding Concerta brand or the [authorized] generic from Watson. All I can get is the pink generic. My question to the pharmacy was “If its pink does it have red dye 40? Many children have issues with that” [Yes, very possibly some people will react to the dyes and fillers in the generics, which are often different than in the brand. I touched upon that in this post.)
10. “The doctor wrote, ‘do not substitute’ and we still received the generic.”
I specifically request Watson and they told me it has not been available. I also had the doctor go back to “do not substitute” and still received the generic (which I sent back). I had to go to a different state to find the brand because not one pharmacy had it. This is getting ridiculous. With our plan, I can only to go CVS or Rite-Aid.
11. “He gets very depressed and says that he is stupid cause he can’t concentrate…”
My 9 year old son had been on Concerta for the last 2 school years. This year he started out fine in October but November he started acting weird: He was always scared, even in the day time’ he wouldn’t be in a room by himself and was always hearing things and seeing things.
His pediatrician told me to take him off the medication for the holidays. That made a world of difference. He is still afraid to sleep alone. But he is functioning like a normal 9 year old.
He is now on Intuniv. All it does is make him tired. He has only been on it for 3 days so I’m hoping it will eventually work for him. He has been home sick this week and when I’m helping him with makeup work.
He gets very depressed and says that he is stupid cause he can’t concentrate…
12. “He was asked to leave the school in November.”
My 9 year old has been on Concerta for several years. We switched him to generic Concerta in June, and I didn’t notice any change. Looking back now, I think this is because he was out of school and his days were just composed of fun activities and free time and he didn’t really have a lot of opportunities to get frustrated over work.
When school started, we put him in a private school that specializes in kids with learning differences. At first we thought he was just taking a while to adjust to a new school, but his behaviors only increased in severity. He refused to do any work, would run out of the classroom, screaming/crying/fits, and eventually started attacking the other kids. He was asked to leave the school in November.
I home schooled him for a month while I worked with our local elementary school to get his services back in place. He has been in this school since he was 3 and we’ve had a great team of aides and support people.
Right before Christmas, he started going to school for just half of the day. We all agreed that since his behaviors had been so much more intense than they were in the past, that a half-day was probably all he could manage. The team at the school has been documenting every outburst/whine/tantrum and keeping a detailed spreadsheet. We have probably 4-5 weeks worth of sheets now and every day (four hours) he has an average of about 10-12 behaviors that require the team’s attention. He spends a lot of time by himself in the resource room, by choice.
Last week, a friend gave me her son’s leftover name-brand Concerta that he was not going to take and it was the same dosage as normal for my son. (Yes, I know this is probably frowned upon, but we do what we can to save money.)
He took the first one on Saturday. On Monday and again today (Tuesday) at school, he stayed in the regular classroom the entire time and did not have a SINGLE issue. This is a child who at times has three adults with him at school to help manage his behaviors and he made it through two days without a single whine, cry, anything.
His team was amazed and asked about any changes in his routine. The ONLY thing different has been the name-brand Concerta. I realize that 2 days is not enough time to establish that this is a definite behavior change that can be attributed to switching meds. But after having every day at school be a disaster since August, getting kicked out of a school that specializes in helping kids like him, and reducing the length of his school day by 50%, this is truly miraculous for him.
I’m sticking with name-brand and hoping that my gut instinct is correct. I had just brought up the possibility of the generic Concerta being part of the problem with his psychiatrist last week. She said that it “wouldn’t be unusual” and wrote a new script to be name brand. Hoping that when our freebie pills run out, our insurance will let us get the name brand again without too much of a hassle.
13. “Her behavior had turned defiant again, like before she started taking Concerta.”
My 8-year-old daughter’s teacher informed me that her behavior had turned defiant again, like before she started taking Concerta. She wanted to know if she had been forgetting to take it. After looking into it, I realized the last refill had been generic.
I found out that, yes, the medicine may be the same in Concerta and the generic. But the capsule is made differently, which causes different delivery amounts and times. Something as small as this made a big difference in my daughter’s behavior.
13. “Holy cow, it was night and day difference for my child.”
Wow, I can’t tell you how thankful I am to come have come across this website. My son has been on Concerta 27 for a little over a year with great results. He has received a generic for each fill, but it had always been “the good one” until this last refill.
Holy cow, it was night and day difference for my child. There have been more tears, emotional outbursts and general unhappiness than we’ve had since before he was diagnosed. This holiday break has been miserable for our whole family.
I finally called his doctor this morning. She just scratched her head and couldn’t figure out what could be different. Maybe it was just the stress of the holidays, she said.
But one of her nurses did some research and came across your information. She called every pharmacy in our area until she found one that carried the authorized generic. Then she got us a new script.
Thank you for getting this info out there. I’m so angry that this drug company messed with people in this way.
14. “My pharmacist had to circumvent the standard procedures of his company”
My pharmacist told me he had to circumvent the standard procedures of his company (a large supermarket chain), in order to get the Actavis product for me instead of the other “generics.”
With this new victory, it should be much easier for conscientious pharmacists everywhere to order the “authorized” generic. Congratulations again, and thanks for all your good work.
15. “I’m about to pull my hair out. If it wasn’t for your website I would have still been confused.”
Recently my normal pharmacies were out of authorized-generic Concerta. So CVS had some of the other generics.
Three days later, I’m about to pull my hair out with my daughter’s behavior. The pills they sold me are the Kremers Urban!
If it wasn’t for your website I would have still been confused. I think the ones in charge should get a dose of meds that produce the same horrible effect it has had in my daughter!
16. “Through your blog, I [saved $193/month].”
Through your blog, I learned about the Actavis “authorized” generic. By presenting your detailed comparisons to him, I got my physician to specifically prescribe the Acatvis product.
When my first script was filled this past March, I stood literally slack-jawed with surprise at the pharmacy counter: the cost was $7! That is NOT a typo: I mean $7—for the very same drug that I had been paying about $200/mo.
Please share your opinions or first-hand experiences regarding these Concerta generics—or other ADHD-related generics you or your child might be taking.
There are no annoying codes required. Thank you!