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We Did It! Concerta Generics on FDA Watch List

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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 Watch List, as of April 21, 2014. But this is an incremental victory, so we should stay vigilant and continue to advocate on this issue.

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.

Some points:

  • If you are confused about the difference between Concerta’s “authorized” generic (from Janssen-McNeil/Actavis/Watson) and the “true” generics (Malinckrodt, 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.
  • 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.

Generic Manufacturer Mallinckrodt’s Response to My Request

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 its horrible efficacy.

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):

http://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? I guess it is 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. Just a guess.

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:

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 Mallinkrodt pill that has M with a square around it and 36. My sons behavior was out of control, almost like he hadnt took 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 snd request the Watson brand Im 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!!!

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 judgement 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 on 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-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! 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 your children.

Here is Mallinckrodt’s response:

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

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

Gina Pera

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  1. Kristen Stuppy’s avatar

    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!

    Reply

  2. Aubrey’s avatar

    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.

    Reply

    1. Gina Pera’s avatar

      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

    2. Aubrey’s avatar

      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.

    3. Gina Pera’s avatar

      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

    4. jenn’s avatar

      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!

    5. Gina Pera’s avatar

      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

    6. Penny Williams’s avatar

      This is AWESOME! I just this week spent 5 days monkeying with the insurance to get the brand name Concerta covered, even after the doctor wrote it as medically-required. I finally got it filled 6 hours after he took his last pill. The generic is so, so bad — not even 40% as effective as brand in our experience.

      So glad to see some meaningful movement on this issue!

      Penny
      http://BoyWithoutInstructions.com

      Reply

      1. Gina Pera’s avatar

        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

      2. tag’s avatar

        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!

        Reply

        1. Gina Pera’s avatar

          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

        2. Danielle’s avatar

          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

          Reply

          1. Gina Pera’s avatar

            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

          2. Laura’s avatar

            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.

            Reply

            1. Gina Pera’s avatar

              Hi Laura,

              Props to your husband for persevering through those phone calls!

              g

            2. tag’s avatar

              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.

              Reply

              1. Gina Pera’s avatar

                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

              2. Cara Edwards’s avatar

                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.

                Reply

                1. Gina Pera’s avatar

                  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

                2. Krista’s avatar

                  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!

                3. Gina Pera’s avatar

                  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

                4. Bi’s avatar

                  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.

                  Reply

                  1. Gina Pera’s avatar

                    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

                  2. BillD’s avatar

                    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!

                    Reply

                    1. Gina Pera’s avatar

                      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

                    2. Tom Nardone’s avatar

                      Gina I could not be more pleased I came to your sight this evening. My wife has been taking generic Concerta for a long time now and I had never heard there was a problem or an issue. Her doctor told her that generics could have no more than a 2% variance. Meaning it was 98% the same thing. Thank You so much for posting this. My studying has only just now begun on this.

                      Reply

                      1. Gina Pera’s avatar

                        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

                      2. AlisonM’s avatar

                        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.

                        Reply

                        1. Gina Pera’s avatar

                          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.

                        2. jenn’s avatar

                          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.

                          Reply

                        3. David Pomeroy MD’s avatar

                          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

                          Reply

                          1. Gina Pera’s avatar

                            Right on, Dr. Dave!!

                          2. Beth H’s avatar

                            My pharmacist has her doctorate. Is that what you mean?

                          3. Suzanne’s avatar

                            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!

                            Reply

                            1. Gina Pera’s avatar

                              Hi Suzanne,

                              I am so glad to hear that my blog helped you to figure it out! Poor kid! Poor mom! Poor teachers!

                              g

                            2. Beth H’s avatar

                              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?

                              Reply

                              1. Gina Pera’s avatar

                                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).

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