Change in Manufacturing of Adderall XR

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This topic contains 20 replies, has 12 voices, and was last updated by  Jdevc 2 weeks, 1 day ago.

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  • #106974

    General_529
    Participant

    Hello,

    I am writing this to inquire if anyone else has experienced adverse reactions or unexpected side effects from a generic form of Adderall XR distributed by Prasco and made by Shire.

    I have been taking Adderall XR to treat my ADHD for more than 5 years with great success- recently I filled the same prescription as I have been for the past 5 years and upon taking it immediately noticed it is not the same drug.

    From the transition point to the recently filled bottle, I noticed my thoughts are constantly disorganized, always feeling distracted in my mind, having trouble seeing the “big picture” as I have done with much ease with this medication for the past five years. The Adderall XR I have been given recently makes it worse and not better.

    I have contacted Shire and Prasco to inquire if they changed anything in the manufacturing process of this drug and to the best of their knowledge they have not, however they did not 100% confirm everything has been the same. They registered my complaint and that was it.

    I have been to my doctor to get evaluated and all of my charts look great. The only thing we could reason was:
    1). I got a bad batch of medication.
    2). Shire changed something with the medication.

    Does anyone take the generic form of Adderall XR distributed by Prasco and notice any changes with the prescription they just picked up?

  • #107238

    Penny Williams
    Keymaster

    There are many generics on the market. And many complaints about them not being as effective. This could be the first time you’ve had this particular generic.

    If you know you’ve had this generic and done well with it in the past, log your insights with the FDA.

    Penny
    ADDitude Community Moderator, Parenting ADHD Trainer & Author, Mom to teen w/ ADHD, LDs, and autism

  • #119784

    Highersource1
    Participant

    Yes, there is definitely something wrong with my new batch. Something is definitely not right. My symptoms are the same as yours. I even notice pain in my left temporal lobes and have issues memory and recalling information. I believe it could be brain debilitating with continual use. Something has to be done cause it is not the same drug at all.

  • #120135

    Mrs.Farnsworth
    Participant

    https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=consumer.reporting1

    Report it and call your doctor.

    More people need to do reports. This has been going on for a really, really long time. When will they do something about it??

    Make a report

  • #120833

    Skypark962
    Participant

    I have been taking Prasco for the last 4 mos & have DEF noticed that it’s not as good as Sandoz. I’m actually going to talk with my Dr about it. The CVS I usually go to, has 5mg and probably higher–but no 10mg, so I have to go to Walmart & they only have (Prasco)–name brand on Goodrx is like $300!

    This is a tough one—bc on paper & their website, it appears that Prasco is the official generic of Shire, which I assume it’s made at the same place. BUT, it’s def not the same or even close to other generics I’ve taken. It’s awful.

  • #129363

    jwilli
    Participant

    Hi, I read your complaints/concerns about the changed formulations in your Adderall, and I’m sorry to hear you’re having that problem…But I’m also relieved to hear that I’m not the ONLY one who is dealing with this problem too! A little about me; I’m an adult with ADD/ADHD. I was diagnosed back in the 90s. I’ve also been re-diagnosed over the years with only ADD/ADHD (combined type as they call it). Thankfully, I have no co-morbid diagnoses. Attention Deficit Disorder is enough to deal with lol.

    When I was first diagnosed my doctor started me on low dose Ritalin, and it was a godsend! It worked very well at helping me focus, stay on task, feel better about myself, and function better. After a couple years the Ritalin side-effects of bad headaches began to outweigh the benefits, so my doctor put me on Dextrostat 5mg, which is basically immediate release Adderall, which worked well too without the distracting headaches. Eventually, I was prescribed once a day name brand Adderall XR 30mg, and that worked best for me all day! I took Adderall XR by Shire from about 1999 to 2004, But shortly after I moved to Michigan around 2004, I started getting name brand Adderall XR that was not the normal stimulant formulation. This Adderall XR was obviously tainted with other drugs, like antidepressants and god knows what else! It made me feel awful and certainly didn’t help treat my ADD! Of course I informed my doctor but she said that she couldn’t control what the pharmacies were selling.

    I filed complaints with FDA Medwatch, and got no response. I complained to Shire and they just gave me the runaround. In fact, they even sent me ridiculous letter claiming their Adderall XR was 108% pure!!… Gee I wasn’t aware anything could ever be more than 100% pure. I tried going to different pharmacies but kept getting badly tainted Adderall XR. So, ultimately I felt I had to stop treatment. I went without treatment for several years and it was debilitating. I sought natural ways to help ease my ADD symptoms too. I started working out regularly, changed my diet and researched supplements, like tyrosine and other natural treatments. All of these lifestyle changes were healthy, and I became more fit, but none of it was better than prescribed stimulants at treating my ADD symptoms. I did however, seek to restart some stimulant med treatment with my doctor just last (2018) year. I’m finishing my degree, and college is tough enough for those who don’t have ADD, but this last year has given me fits with my ADD symptoms.

    So, last year 2018, I had a long talk with our family doctor and he suggested I try a stimulant called Vyvance. Since going back to school in 2016, to finish my degree, my untreated ADD symptoms were making my ability to focus and concentrate on studies doubly difficult! My doctor prescribed low dose Vyvance, and initially it worked surprisingly well. Vyvance is a prodrug, amphetamine type product. It’s milder and doesn’t last as long as Adderall, yet it still helped me to focus and concentrate. But after a few months of this treatment, I started getting badly tainted Vyvance too!! Vyvance is a patented drug made by Shire. According to their own website there are no (legal) generics available until 2023. Given those facts, I’m still reasonably certain the Vyvance I’ve been recently getting is tainted. Because not only am I familiar with how pure (lisadexafetamine) Vyvance feels and works, I also took a urinalysis that showed other drugs were in the “Vyvance”. I shared this with the doctor, and he thinks I should get it tested and find a lawyer. That’s all well and good if I only had 10k to give a law firm as a retainer…So, again, I filed FDA complaints but to no avail, and even contacted some attorneys. My doctor agrees that there is a problem with what I’m getting at the pharmacy – but he isn’t sure what he can do about it either.

    This illicit tainting of stimulants is a real problem. No doubt it’s highly unethical and probably illegal too! So far what I’ve found to be one of the most difficult challenges is getting anyone in authority to listen, and then do something to help! Unfortunately, those of us who complain too loudly about getting sub par (tainted) controlled schedule II “stimulants” also run the risk of giving some people the wrong impression. You know? All I can say is tainting of ANY medication is just inherently unsafe, and flat wrong! But until now I’ve had no contact with others like yourselves that I can even discuss this problem with…Hopefully we can share our insights and experiences and work together to help each other find a solution.
    Sorry to go on, but there is much to say about this problem. Please don’t hesitate to respond. Thanks, jwilli

    • This reply was modified 5 months ago by  jwilli.
    • This reply was modified 5 months ago by  jwilli.
    • This reply was modified 5 months ago by  jwilli.
  • #129581

    Suz4nn3
    Participant

    OMG I’m so glad to have found this post.

    I have been scrambling and researching and visiting various pharmacies looking for the generic I’d had for a couple of years. It wasn’t great but it didn’t give me a raging headache. Independent store found a diff gene ic. Not great but better. It’s insane that we can’t get what we need.

    Is it bc of the neurological disorder we have? That People don’t believe it’s real? Or that they think we’re trying to get high? Or that there are enough people diagnosed to make it worthwhile to Big Pharma and the Insurance Industry? I’m in my 60s. I can move through my life better with quality medication. But I, too, am ready to give up and go without therapeutic meds. Which is just wrong.

    If only we could combine our voices and power and effect change in the manufacture of useful ADHD help.

  • #129658

    kashmir358
    Participant

    Recently I had to switch to the generic brand of Adderall XR. I always took the name brand type but it has gotten too expensive for me. I have noticed with the generic that my mind doesn’t feel right. I was on 30 mg. for years which was okay but I have a lot of trouble sleeping so I figured I would try to bring down the dosage, so it’s not that. I switched to 10 mg in the am with the generic brand. I am glad that I have seen the complaints and will switch back to the name brand and see if there is a difference.

  • #129674

    Jessy
    Participant

    I work in biopharmaceuticals testing and formulating drugs being produced. Prior to this, worked in various areas of medicine for 18 years. I also have been on the Prasco manufactured Adderall XR 30 for 2 years. My insurance company switched and name brand isn’t covered. I’ve experienced the same issues you all have described. In addition, I’ve developed weird health problems, like hypertension. My BP has ALWAYS been 112/64 or in that realm. No family history of hypertension. Yes, I’m aware of all the factors that can contribute to health issUes weight gain, salt intake, etc. I have heard all the possible causes for the change in efficacy, such as tolerance. I tried switching to 20 mg for awhile and then going back up and no improvement. It’s definitely the drug itself. I noticed it immediately the first time I was accidentally written an rx that wasn’t “dispense as written” (prior to being forced to switch due to insurance). Heart palpitations observed at 6 hr mark made me feel like the R-enantiomer and S-enantiomer proportions weren’t shifting at the same rate as the brand drug. I’m going to look into this further. Contrary to efficacy claims, generics don’t have to adhere to as the same documentation stringency as the innovator drug had to go through. Things in the formulation can differ and the molecule has been seen to having varying aggregation or stability issues across manufacturers. Look into this, there’s data out there demonstrating. Even if the structure change isn’t at the active site of the molecule, there’s been noted changes in efficacy. For example pseudoephedrine in Sudafed that was altered very slightly to prevent misuse of the drug. Blind studies showed a difference in effect. Insurance companies want to save money (I’ve written many appeal letters on behalf of patients, trying desperately to get their drug approved rather than have them try/fail 8 other drugs first). It’s very sad that doctors cannot often use a tried and tested (ie shown to work well) drug without a patient being put on another type. I’ll stop rambling. I just want you all to know it’s not imagined. 🙂

    • #129690

      jwilli
      Participant

      Hi Jessy,
      Thanks for your input. I’m glad someone with your experience and expertise is part of our discussion! I’m currently finishing up my degree requirements in the science/medical field. I’ve been fortunate that certain areas in my studies have kept me in touch with research on psychotropic medications. Especially in regards to indicated use, contraindications, side-effects, and drug interactions. Having said that, I too have learned that generics don’t necessarily have to adhere to the exact same molecular structure and documentation. Even subtle changes in a formulation can sometimes disrupt the intended efficacy of a drug/med. The problem I’ve been confronted with however, is different and involves several layers of problematic pharma issues. I was diagnosed with ADD combined type in 1992, and over the years my treatment history reflects very positive results from the pure untainted stimulant medications from Ritalin, to Adderall to Vyvance. I say PURE because the problem I’m having is that I’ve discovered other powerful non-labelled psychotropic drugs like antidepressants and anti-psychotics, and god knows what else have been added/compounded in some of the “stimulant” meds I’ve been prescribed. I’ve never been diagnosed with ANY co-morbid disorder, so these other drugs aren’t (legitimately) medically warranted. The first incident involving drastic formulation changes in my Adderall XR began back in 2006. I noticed this immediately after taking the first dose of my new prescription of Adderall XR 30mg. I of course notified my doctor and he suggested that I may have got a bad batch. But when I went to another pharmacy with a new prescription it too was badly off from the usual therapeutic stimulant effect. Bottom line, I was eventually informed that certain doctors and officials at a Federal level believed it’s OK to taint a patient’s stimulants without informing them. I say BS! I have always been an excellent compliant patient, and have NEVER had an adverse effect or been accused by my doctors of misusing my stimulant meds. Anyway, – Due to the sudden, awful and unwarranted formulation changes in the Adderall XR 30mg I had to stop treatment altogether…And I stayed away from treatment for almost 8 years! Last year however, after noticing my ADD symptoms rearing their ugly head in my school work I had a long talk with my doctor. He decided to prescribe Vyvance and it initially worked pretty well for me. No side effects beyond the usual dry mouth, suppressed appetite and occasional insomnia. But after just a few months of good treatment with Vyvance I once again got a tainted batch! This time I even verified this by taking a urinalysis which showed positive for other drugs that are NOT listed as active ingredients and NOT supposed to be in Vyvance! MY doctor agrees that the problem is at the pharmacy level and he even suggested that I get an attorney. As you may know the active ingredient in Vyvance is a prodrug called lisdexamfetamine dimesylate. It’s designed to activate into L-amphetamine only after it combines with lysine in the digestive tract. But that is the ONLY active ingredient that supposed to be in the drug. Vyvance is only available in name brand, by Shire. A generic for Vyvance won’t be LEGALLY available until 2023. Frankly, I think a lot more people are getting tainted stimulants, but if they haven’t been in treatment very long then they likely don’t even know the difference between what’s pure and what’s tainted…I suspect this is especially true with children. They simply don’t know any better, but their parents must be deeply concerned and wondering why the “stimulant” medication isn’t working to relieve their kid’s ADHD symptoms like it used to…I’m sure there’s a lot of frustration and bewilderment to go around.

      • This reply was modified 4 months, 4 weeks ago by  jwilli.
      • This reply was modified 4 months, 4 weeks ago by  jwilli.
      • This reply was modified 4 months, 4 weeks ago by  jwilli.
  • #130956

    jwilli
    Participant

    I find it interesting that the dialogue abruptly stopped over a week ago. Hmm why is that? Would anyone like to add to the discussion? Or offer any helpful suggestions that might shed more light on the issue of inconsistent efficacy, and tainted stimulant medications? I had hoped we could find some mutual answers and support on this site. I hate to sound cynical, but I’m well aware that money and certain influences can have a way of sweeping problems like “bad” medications under the rug. So, I hope I’m wrong about that and everyone will feel free to express their experiences and concerns here. For me, it’s all about restoring good treatment!

  • #130979

    Suz4nn3
    Participant

    Please be aware, jwilli, that this Adderall discussion was resurrected from January and then June, so it hasn’t been a rousing exchange of ideas at any time. People like me, with ADD, get distracted by other things in life. Plus, really long posts are draining to read. Plus, poor ADD-meds supply is a perennial problem, so how much more is there to add until the next batch turns out to be even worse than the last? This is long-haul-solution problem-solving.
    Back atcha in a coupla months.

  • #130985

    jwilli
    Participant

    I’m well aware Suz4nn3 of the flow of the conversation by the dates next to each post…I just noticed that a few like yourself had recently posted. In fact, your initial post on September 30 “OMG I’m so glad to have found this post” sounded somewhat “rousing”, and I was glad you joined in! I too get distracted by other things in life, ALL the time! I also agree however, that we need to combine our voices on this tainted (undisclosed active ingredients) medicine fraud. I apologize for my lengthy posts. I get exited and tend to over share at times. It’s just that I have a long ADD (stimulant) treatment history, since 1992, so I know from where I speak about the tainted stimulant meds. I had no problems or complaints with my ADD treatment until I moved to Michigan in 2006 and received my FIRST prescription of tainted stimulant (Adderall XR)and now Vyvance too. So, the poor ADD-meds supply hasn’t been a perennial problem for most of my treatment history. But today the supply chain is corrupt, and that’s wrong on so many levels! BTW, can you please tell me where you live? I’d like to have an idea where the problems are at. I’m crossing my fingers that your next batch is better for you!

  • #131126

    Suz4nn3
    Participant

    I’m in the Philadelphia area.

    It seems that, every few months, one manufacturer quits making its off-brand concoction and that another manufacturer steps up to supply for the next few months. That one stops, and a third maker takes its turn. It’s creepy. I picture them sweeping up the factory floor and including that in the capsule mix. Every coupla months I consider quitting meds. The efficacy can be so piss-poor and unhelpful. It’s interesting that you didn’t always have this dosage/quality problem. I wonder when it started. Probably before 2006. And why. And how. But mostly I wonder what we can do to stop it.

  • #131127

    Suz4nn3
    Participant

    And my doctors can’t seem to help. Pharmacists are sympathetic but not encouraging. Why should the patients have to research the manufacturers and distributors and hunt down the answers and scramble for solutions? It IS wrong.

  • #131168

    jwilli
    Participant

    You are right, it is creepy! As well as corrupt, unethical and in the light of day illegal. I realize this is an open post on a site that gets advertising revenue from certain drugs makers that I’ve criticized. So, with that in mind I’ll share SOME general insight on this problem as I have come to know it over the years.

    First of all, I’m sure we’re all aware of the stigma that’s attached to taking prescribed stimulants. Sad fact is, even some in the medical field are against stimulants, while others have ignorantly compare prescribed stimulants to meth. Ridiculous! Unfortunately, I’ve learned from some ethical doctors who treated me, and a few other credible sources that this illicit cocktailing of prescribed stimulants is no accident. It’s actually a “program” for lack of a better word, that was originally (back in the late 80s and 90s) touted as a patient abuse deterrent, and more importantly to stakeholders, an oversight protection for the pharma stimulant makers, and doctors to help shield them from lawsuits. I believe the original concept wasn’t designed to be nefarious, but as the cliché goes, so much for good intentions; money talks!

    As you may recall in the latter 90s ADHD became more diagnosed and stimulant prescriptions became more prevalent. So, the media started reporting that development, along with the skyrocketing college abuse of simulants too. Which made the oversight become more of a political lightning rod issue. Once that happened the MONEY “influencers”, such as pharma lobbyists, and other special interest types who’s agenda had nothing to do with good ADHD treatment practices came pouring in. But the real turning point that led to tainted simulants, and the abuse of a patient’s right of informed consent for stimulant medications wasn’t implemented until 9/11.

    As we know 9/11 and the subsequent Patriot Act changed the rules on a lot of our civil liberties, and on how communities can “police” themselves. During that period, some so-called “officials” used the opportunity to include a category of people taking prescribed stimulants as a possible threat to National Security because as they stated stimulants can cause insanity… Nevermind that insanity due to prescribed stimulant use is so rare, that NIMH and SAMSA ranks it as extremely rare side effect after dry mouth! But the bottom line is this quasi-legal system is now rife with blatant abuse. People like us with ADHD can essentially be turfed without good cause from getting real pure simulants to treat their ADHD for virtually ANY reason.

    I don’t mean to sound sinister, and I’m not a conspiracy theorist. But what I can confidently, and verifiably say is the system is seriously broken and corrupt. The only chance I see for things to change is if we speak up and collectively work together. Because my biggest concern is if we allow our stimulants to be tainted with undisclosed other active ingredients, then whose to say that other drugs won’t get tainted too. As a parent I sure as hell wouldn’t want my daughter to go through any of this medication fraud. If you aren’t informed about what is in your medicine it could seriously harm you or worse. That’s all I got. I wish you all well.

  • #138913

    Melanieem
    Participant

    Hi. I have experienced all of the bad side effects from various manufacturers of generic Adderall XR. Sandoz was the only generic version that seemed comparable. I was able to get that because I was on vacation in Myrtle Beach. Couldn’t find it in Richmond VA. Anyway, I was about to give up, when I got a letter from my insurance company stating that they would no longer cover my Adderall XR generic, but would cover the brand,and it would not cost me a dime more! So beginning Jan 2020, I have had Brand from Shire. Well something is wrong with this picture. First of all, earlier months ago, I had skimmed an article stating that insurance companies were making deals with the pharmaceutical companies,so that the Brand would be the only thing covered, which would be financially advantageous to both. At the time I didn’t get it. Now,since it has happened to me, I do get it. Let me add that this BRAND ADDERALL XR is not the original formula. That is why they did this…people would be forced to buy it from them, and/or would not keep complaining about the quality of other versions, since the brand was no better. I would not say this at first, thinking maybe it is just me…but no, this is not the same BRAND ADDERALL XR, and Shire is not losing money,since this stuff is most probably made with the same cheap ingredients as their generic counterparts. Maybe they figure that if the way it is released into the system IS the same as the original, then cutting corners on the actual ingredients is OK. Anyway, if you can find generic Sandoz, and your insurance company has not stopped covering generics, then that is your best bet.I cannot express how disappointing this is for me. Think about it…why else has this happened? I believe you all are right, in stating that no one feels the need to worry about the opinions concerning efficacy from drugged people…it is probably laughable to them. God help the poor children who do not have the mental acumen, or awareness to point out the obvious differences. I will contact Shire also, but know exactly how I am going to feel over their lack of concern. Disgusted.

  • #139288

    Suz4nn3
    Participant

    Dear Melanieem, thank you so much for posting about your experience. And I just noticed General 529’s post as well.) Have you registered a complaint with the manufacturer and/or FDA, as suggested by moderator Penny Williams and poster Mrs. Farnsworth? Not that either of those things will likely do much good, but we need to do all we can. I almost feel as if we consumers are on our own out here, wandering the wilderness, helping each other find efficacious support with our daily ADD struggles. It’s infuriating to not have a reliable government watchdog agency for medications. And alarming we can’t find reliable medications,

    Let’s please keep posting and helping one another and TRYING to get our concerns at least HEARD.

    • #139336

      Penny Williams
      Keymaster

      Reporting can change things! FDA got so many complaints about the generic Concertas in the beginning that they ended up revoking their equivalency status.

      Penny
      ADDitude Community Moderator, Parenting ADHD Coach & Author, Mom to teen w/ ADHD, LDs, and autism

  • #139520

    crbattist
    Participant

    I have too much to say about this. This months Rx has me far more concerned than any month before (inflammation in my stomach and joints, seemed like thyroid hormones were all over the place and mental bizarreness (and I am a musician/artist, I know good weird, and this wasn’t it). I take 10mgXR from Shire and a 10mg IR made by Lannett Co. The first time I received a Rx from Lannett I was concerned, after some research I found this website and a similar thread about generic pharmaceuticals. This was my initial discovery of how low the standards are for a lot of generics and how much manufacturing and distribution politics (and more) play a role in the substance I am putting into my body. I drink green juice, ginger and turmeric cold pressed and kombucha and electrolytes to combat some of the side effects and help my body cleanse and two days without this was noticeable while still taking the Rx.

    The fact that a urinalysis showed antipsychotics and antidepressants is extremely alarming. I suppose it is manufacturers AND pharmacies in the wrong because I believe pharmacies are required to test the drugs they get… but maybe they aren’t, there’s also probably some bogus law that allows trace amounts of other drugs to be in some other drugs. Anyway, I will access a drug testing kit if I can and/or do an urine analysis myself. I thought I would contribute to the growing body of evidence that WE THE PEOPLE have a lot of work to do and IF you are someone that has capability and power, now is a good time. Also if you’re struggling out there with mental health and/or pharmaceutical entanglement, there is a much bigger picture to our individual health and if you saw it, your personal shame might just be lifted and relocated to the corporations that say they are helping. Course many of those corporations are being run on the ground level by people just like us… It’s both simple and complicated. I will navigate out of this entanglement and post anything helpful when I can. Thanks for the shares and insight.

  • #141784

    Jdevc
    Participant

    So some of you are having problems with brand name? That is so disheartening. I was on brand name when I was first diagnosed. Things went really downhill when I switched to generic, specifically Actavis. Really downhill. After 5 years on the same dose of brand, we switched to generic. Once we went to Actavis, I ended up for 2 years abusing my meds, becoming an alcoholic and spiraling out of control. When I was abusing the meds, I kept thinking to myself. If I take more, then eventually I will be able to think clearly again and get myself out of this mess. Long story short, I went through treatment for my substance abuse and was off meds for 2 years. Last winter, working closely with a Dr I started back on meds. We tried different types,but eventually ended back to Adderall xr,(generic). I have tried different generics, hoping to get back to where I was before. It has been trying. Some have been worse than others, but Prasco has been the worst by far. I was going to ask my Dr to specify brand name, but after reading everyone else’s stories, I’m worried it’s just fruitless. I’m still going to try, but if it’s as bad as it sounds I will be raising my voice too.

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