Generic Concerta: Health Canada to Review

Generic Concerta was introduced into Canada around February 2010. As I’ve written in my full article about Generic Concerta – I’m quite concerned about the fact that the new generic medicine does not have the same properties as brand name Concerta – and this may lead to problems for patients who are automatically switched from brand name Concerta to Novo-Methylphenidate ER C.

You may wonder – am I against generic medicines?

Not at all.

In fact, I have taken many generic medicines myself, and so have my family members.

The issue is that for most people, taking a generic for stomach issue, or for asthma is often completely fine. It is however different, in my opinion, to take a generic for a psychiatric condition, such as ADHD.

The other big difference is that Concerta was developed based on the principle that its pharmacokinetic profile is different. What does that mean? It means that the way the medicine is absorbed throughout the day has an impact on how the medicine works.

In other words – in this ‘next generation’ medicine – the old rules for how to create a generic shouldn’t really apply. Just assessing whether the new generic has similar medicine absorbed throughout the day misses the fact that the rate of absorption of Concerta is part of what makes it so effective.

Advocacy Works:

Thankfully, our friends at Health Canada are listening. They have at least acknowledged that there may be a difference with how they should evaluate generics when it comes to medicines like Concerta.

Health Canada has created a committee called: The Scientific Advisory Panel on Bioequivalence Requirements for Modified-Release Dosage Forms (SAP-MRDF). Their draft terms include the following wording:

“The Scientific Advisory Panel (SAP) on Bioequivalence Requirements for Modified-Release Dosage Forms (SAP-MRDF) provides advice to Health Canada on appropriate bioequivalence standards for modified-release dosage forms of pharmaceutical drugs. Of particular interest are those drugs where concerns have been raised that existing standards may not be adequate, for example, methylphenidate and nifedipine. The Panel provides Health Canada with advice and recommendations, but the decision-making responsibility remains with Health Canada.”

This committee will be meeting in Ottawa on June 11, 2010 to receive input and submissions to understand the complexity of this issue.

Hopefully, this process will bring forward the science that Novo-Methylphenidate ER-C does NOT have the science behind it to be defined as a generic form of Concerta. This would then change it to be another lower cost option for people to use for ADHD, rather than a medicine which is automatically substituted for Concerta.

I will update this blog with information as I receive it.

Best,

Dr. Kenny

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Comments

  1. If Health Canada and TPD thought there was a problem, then why was the drug approved in the first place?

  2. I definitely have to agree that this medication does not act in the same manner as Concerta. Similar to Ritalin, its effects are stronger earlier on in the day and the strength weakens as the day progresses. In addition, this medication did not have the same long acting effects as Concerta (likely due to the lack of capsule and controlled release that results from the capsule).

  3. TThumper – the issue here is that health Canada is now looking at the fact that they may need to evaluate certain medicines differently – i.e. the current criteria aren’t accurate for the medicines like Concerta.

  4. I take Concerta 36mg and it costs $103 a month (30 pills). I don’t have a health plan. When I went to get my refill 2 months ago, the pharmacist asked me if I wanted to buy generic Concerta for about $60. I asked if it was exactly the same. She said yes. I asked if it had the time controlled release mechanism, she assured me it was exactly the same. So wanting to save money, I said yes. Luckily, she also told me about the Concerta co-pay option and I of course opted for that. When I asked my psychiatrist about this generic Concerta, he told me not to get it and said it wasn’t as good. I continue to use the co-pay card now and have noticed that my Concerta was even cheaper the last time I purchased, though the actual Concerta cost before the co-pay card was the same, the co-pay paid out more. I assume the generic concerta got even cheaper.

  5. Dr. Handelman,
    Any word on the results of Health Canada’s review of Novo-methylphenidate ER-C? Will they continue to define it as the generic form of Concerta?
    Thanks!

  6. My daughter has been feel sick to her stomache and dizzy off and on for a month. I’m beginning to thing the generic concerta is the culprit. I will test it tomorrow.

  7. Personally, I believe the generic concerta is downright dangerous. Methylphenidate was never meant to be consumed in single doses of 54 or 72 mg. Concerta allows for those “higher” doses specifically because it will absorb slowly throughout the day, and do so reliably, every time. I’ve been taking it for six years, and it has never once suddenly dissolved too quickly on me because I drank something acidic, or because I took it on an empty stomach, or because the pill was flawed. Six years, and not one incident of “sudden absorption”, for lack of a better term.

    How do I know this for sure? Well, if you’ve ever taken too much methylphenidate, you’ll know it. In my case, aside from the obvious physical symptoms, my blood pressure can spike dangerously high. This happened a few times on the old Ritalin SR when I absent-mindedly took two 20 mg pills instead of one (I’m ADD – it happens). Currently my BP is well-controlled with another med, but I would be downright afraid to have 54 or 72 mg of methylphenidate hitting my bloodstream all at once. And I’m a 210 lb adult. Imagine a 50 lb child!

  8. After taking Concerta for over a year and changing my life, I decided 4 months ago to try the generic without a thought. 3 months of me not sleeping, so super focussed in the morning but spastic at night but thinking it was something else. I even went to the doctor a month later and said “I feel like I am not taking my meds.” But we chalked it up to some issues with my family as I hadn’t thought about the generic brand to my doctor.
    I am now back to the regular Concerta but feel nutty as my body tried to regulate everything again. Don’t do it. Don’t use the generic brand. It’s like taking Ritalin instead of Concerta. It needs to have a buyer beware sign.

  9. 3 days with the generic and my 16 Y/O has noticed a difference and inability to control his environment later in the day. we are seeing mood swings and definite change as well.

    We will be paying the difference. Hope the pay card comes to Manitoba, we just got mandated to the generic last week. back to the doctors office again…

  10. We switched my 12 y/o daughter to the generic on Sunday of this week and today, I am eating the cost of refilling the full original concerta prescription. This generic stuff is garbage. She has made so much headway in the last few months and I’m worried we’ve lost it all for a few days of a cheaper drug. Until recently, the concerta was an EDS drug here in Manitoba, so I’m shocked that already we’re moving to a generic. I am lucky that my drug plan will cover it, but so many are stuck with the generic. I feel for those children and parents.

  11. My 15yr old son has been taking concerta for 2yrs. Previous to that he was on Ritalin, which he developed tics, aggressive behavior, suicidal thoughts, and irritability. For the last 2 months his meds have been switch to the generic concerta, and has redeveloped tics and other behaviour issues. Iam currently wait to see his doctor to discuss our options, fighting with our drug company to cover concerta (Will even pay the $27 difference a month but they say I would have to pay the entire cost) and have wrote a letter to Health Canada. Iam at a loss this is my sons well being and mental health at risk. They have replaced something that was working and replaced it with something that clearly doesn’t!!

  12. My son has recently switched from Concerta to a generic version of Concerta. In Manitoba, the medicare system has just aproved it as a substitute for Concerta and therfore the pharmacists are required to use generic instead of Concerta. I can honestly say that my son has taken a drastic turn for the worse on this substitute product. It is as though he hasn’t taken it at all. He was on a cocktail of Stratera, Resperidone, & Concerta and this new stuff has thrown 3 years of work right down the drain. This BUNK generic product will never go in my childs mouth again.

  13. My 10 year old son has taken Concerta for almost 2 years. As we do not have a drug plan to subsidize the cost of the prescription….$110/month, we decided to give the generic brand a try. Six days later, we’ve refilled the prescription and paid the extra $40. The generic brand caused extreme mood swings, emotional turmoil, the worst feelings of depression, not to mention the lack of focus and attention and hyperactivity levels, all symptoms the medication are supposed to help with. At 10 years old, my son asked if he could stop taking these generic pills because he felt awful and he himself knew it was the pills causing the problem.

  14. My son was switched to generic concerta a month ago. He has developed night terrors, panic attacks (mostly at night) and is restless at night, waking every few hours. Has anyone else had these side effects???? Switching back to regular Concerta ASAP, he was so well controlled on it.

  15. I just recently started taking generic Concerta and am finding the side effects are the same as if I was taking a much higher dose. I’m not normally hyper, but with the generic version I am very anxious and can’t calm down for several hours. The side effects are almost instant, about an hour after taking it I am nervous, anxious, and overly sensitive to noise and commotion. I’ve called my Dr. and asked him to send a note to the pharmacy requesting no substitutes.
    How can a substitute be so far off the mark? And be approved!

  16. why do you read about the new generic brand of concerta and it is praised over the old concerta on many testimonials , then another site it is considered posion ???
    totally confused !!

  17. Both of our daughters were on Concerta, until the pharmacy switched them to the generic without telling us. Over the next month or month and a half we wondered why it didn’t seem to be working any more. Efficacy was lost by noon, as opposed to suppertime or later with Concerta. Something twigged in our minds and we checked the formulation – generic. Following some research, including this site, we contacted our physician who confirmed that a percentage of her patients were making the same complaints. Our girls are now back on Concerta, but the kicker is that our insurance will only pay for the generic. Hopefully, once HC rules that they aren’t the same, our insurance will start paying out for the real stuff again.

  18. The pharmacy just filled my Concerta 54mg script with the generic Methylphenidate ER without asking me!

    Unfortunately, I didn’t notice the switch until I got home and now there is nothing I can do about it. Even worse, the co-pay was exactly the same so I didn’t even save money. I have a call into my psychiatrist about whether I should take the generic.

    I’m so angry that I’m crying. I do appreciate this forum, and feel better knowing that other people are dealing with similar issues. Best, CM

  19. For the past eight years, I have used Concerta to treat the symptoms of an ADD/ADHD that
    was induced by blunt trauma and severe abuse
    during early childhood. Dosages have varied from 1.0mg/kg to 0.5mg/kg. My symptoms
    were alleviated as soon as I started to use Concerta. I have stopped using it on occa-
    sion and learned through trial and error to
    minimize the daily dosage because hyperten-sion became an undesired side effect.
    When I switched over to the generic form of the drug (Watson), it became immediately
    apparent that the results were dramatically
    different. This is NOT the same formula;
    it does NOT work and produces unwanted
    feelings such as jitteriness, anxiety and
    depression. Why am I not surprised?
    You get what you pay for.
    In this case the indifference of corporate health care must be opposed and exposed. Generic psychiatric drugs are dangerous.
    Sweeping aside prudent practice to “save taxpayer money” is a coverup for white
    collar piracy.

  20. My 8 year old daughter has been on Concerta ER 18mg for almost 1 year now, it has truy been a miracle drug for her. Prior to her taking it she was all over the place and very loud, high strung, agressive and completely unfocused and resistant to every aspect of her life-I would drag her to school kicking and screaming on some days (no lie!). When she started taking Concerta we noticed an immediate change, she was able to focus on her classwork, relate well to siblings, and has even made some friends and start going to birthday parties. She bacame this little social butterfly who loved school.It was like somebody turned on the light switch for her. BUT last month when we picked up her refill prescription at Kaiser I immediately noticed that we recieved a generic version, I requested a consult with the pharmacist and he assured me the Watson generic brand was just as good as the name brand McNeil and even pointed out that the medication is manuactured at the same lab and sent to both suppliers and that they both have the same “alza18″ stamp in the pill, which he took out to show me-he said it’s the exact same pill regardless of which supplier it is from. Well, what he said makes perfect sense.

    BUT after 2 weeks of my daughter being on it life is hell around here, in fact it was terrible the first couple days after she started on the “generic” from Watson. I thought maybe she has the sillies or is coming down with a cod that is making her irritable, but it never passed. She is worse off than before she ever started medication. I don’t know how this is possible if they are supposedly the exact same pill, (with the same stamp) only in a different bottle as the pharmacist said. It sounds a little crazy, but her doctor seems to take it serious and we have an appt scheduled tomorrow for a physical & re-check (which was aready due before her next refill) and her doctor said she will write a new prescription and mark her record that she is to recieve name brand only. It’s been very frustrating for me and my daughter, I’m hoping that once we switch back she can get the same effect from the medication that she was getting before the generic came into play and am curious if anybody else has noticed the same problem?

      • I work for Health Canada and this revelation is typical for their “decisions”. Lobbying by generic drug makers is powerful and persuasive. They are as much “in bed” with Big Pharma as the U.S.FDA is. Sign. Thank goodness for co-pay by the mfr of Concerta.

  21. My daughter was recently diagnosed with ADHD and the doctor gave me a sample of 18mg concerta…we had great success. Less argumentative, better social behavior and slight improvement with concentration…so we opted for the next dosage…27mg…pharmacy game me generic and said it was the same…I am not sure if it is the dosage or the generic, but she is now paranoid, up and down, and a zombie at certain points….and it seems to hit her fast when she takes it. I called the doctor and asked if he could redo script with no substitution…going to try the real deal again before I blame the dosage…based on what I have read here it is very well the problem of the generic drug

  22. If you suspected there was a difference between the Generic Concera (novo/teva-methylphenidate ER-C), and the real thing, you were right. A recent clinical study shows a clear difference between the two, with the generic releasing almost double the amount of drug into the bloodstream within the first 4 hours after taking it, and about a third less drug between 7-12 hours after taking it.

    In other words, it’s like taking a significantly higher dose up front (you’ll be wired all morning), but it will only be effective for about 7-8 hours instead of 9-10 hours with Concerta.

    Here’s a link to the head-to-head clinical trial with the test results published May 2011:

    http://clinicaltrials.gov/ct2/show/NCT01118702

    http://download.veritasmedicine.com/PDF/CRO17179_CSR.pdf

  23. My boyfreind and i recently combined our families (a week ago). His 10 yr old daughter has ADD and ADHD. i have known her for a year and i am well aware of how she behaves and how it all effects her.

    She has been having some major difficulites/issues. I assume that puberty is part of it- but after a meeting with her teacher, we thought perhaps an increase in dosage might be in order. The drug no longer seems to be working the way it used to.

    i decided to research her affliction and the drug more intensely to help me help her. i am a part time teacher and i also run youth programs, so i am well aware how many children have this affliction and how it challenges them.

    it wasnt until finding this site that i learned her medication was swithched to the generic. she kept calling it her concerta, but the pill bottle had the generic name. i didnt know the difference.

    everything that has been said reflects what i see in her and what she says- right down the the crying all night. i am thankful for all of this enlightenment so i can now go to her doctor for a ‘no substitutions’ perscription. i am also hoping that the price difference no longer exists, as i read in one article. i am not sure the co-pay program ever existed in this province (manitoba) any ways.

    kindest regards to all of you.

  24. Hi,
    I just wanted to say that I’m very thankful for this site and the input from others who are living with this disorder. Its a great way to share important info and experiences that is definitely helping others as it helped me.

    After 27 years of not using medication to help cope with my ADAH issue I was recently prescribed Concerta. Reading how the generic version is definitely a different product from some of the users experiences, this concerned me so I contacted the pharmacy to confirm that I was given the right version. I was and then told that if you don’t want the generic version to make sure your doctor adds to your prescription “no substitutes”, and let the pharmacist know verbally as well.

    As well I also hope that this issue of the generic Concerta is brought out further to Health Canada; as this is a time released narcotic and could be a serious matter for some of the patients who are unaware of the potential differences that can take place.

    Regards

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