PSA! Concerta? Gone. Vyvanse? Broken – And Jane Called It a Year Ago

Jane McFadden:

Hello and welcome to ADHD Mums. Today we have a public service announcement episode. It’s called “Concerta’s gone, Vyvanse is broken — what now?” Please listen and share this with anybody who is on Vyvanse.

We are talking about something that’s very quietly wreaking havoc across Australian families behind the scenes right now. We are talking about ADHD medications and how they’ve changed. And I don’t mean a new prescription.

I mean this is the same medication, the same dose, the same person, but it doesn’t work the same anymore. Specifically, Vyvanse. And what’s happening right now with this medication and the system around it is something that we all need to be talking about and sharing this episode.

Because I’m hearing the same thing from adults, parents, prescribers and teachers: my child’s medication has stopped working. I thought it was just me. Why am I back in burnout when nothing else has changed? My son is being punished at school again. I don’t know why. I thought we were past all of that.

But here it is. You are not broken and neither is your child. And you are not paranoid, and you are not imagining it. I am so sick of the amount of gaslighting that happens to us mothers. First, it says no issue. It’s that your child is fine. It’s your parenting.

Eventually, we may get diagnosed. Eventually, we may find the right medication. But then we get on it, the medication changes, and then we are told that’s not real either. That must be in your head or your child’s head. This drives me insane.

This is real, and the fact that no one is talking about it makes it worse. I’m going to give a really quick overview about how this started because it’s important to understand the steps as to how we got to this complete crisis that we are at today. Let’s go back one year.

If you followed me a year ago, you’ll remember when I launched a big petition into the shortage of Vyvanse. I petitioned on change.org but I also petitioned the government specifically and the Health Minister. I was featured in the news, on TV, radio, and paper.

Now, at the time, we were told that we should switch over to another medication until Vyvanse came back in stock. Now, Vyvanse is not like any other medication. So the advice was to go over to Concerta, which is the other long-acting eight to twelve-hour medication. However, it’s a completely different drug, so it doesn’t work for everybody. That’s the first problem.

But secondly, I said loudly, over and over, do not move everybody to Concerta because if you funnel the entire country into one option, Concerta will run out next. That is not the answer. Yet the government did not listen. I started the petition. I posted the warnings. I contacted the media. I contacted MPs, everybody around me — politicians — and I said the same thing.

Somebody needs to think about the long-term plan. What about supply and demand on Concerta? I’m concerned we are going to actually create another problem. One of the reasons that I thought that might happen is because of the amount of time it takes to change over medications.

So for a lot of people, by the time they change the medication over and then Vyvanse comes back into stock, they then can’t go back over to Vyvanse easily because it takes so long for all the appointments and it’s so expensive. So I thought we are going to end up with most of the country on Concerta and then Vyvanse will come back and then what?

When I say “and then what,” I mean this is the problem we have. So Concerta has now run out. Australia is completely without Concerta until December 2025 this year. There is no backup plan. There is no forward thinking. Do they not know or do they not care? I don’t know. I think that’s a great question.

So cut to now — the Vyvanse issue. Okay, so Concerta is gone. It’s not going to be back until December 2025, and it may even be longer than that. So people, of course, are starting to move back over to Vyvanse or they are trying it for the first time, or they’re going back on it because it was in shortage last year.

But now people are saying very, very similar things. They’re saying this feels off. It’s not working like it used to. My child’s not coping. They’re spiraling again. I’m experiencing side effects I didn’t have before. It’s the same theme over and over, which to me really raises red flags because when I hear people talk about Vyvanse, particularly, it is one of the medications that I find most people say positive things about.

The amount of negative feedback that I’ve seen on Vyvanse in the last few months has not been what I’ve ever seen before, and that was when my ears pricked up. So of course we have started investigating — and what have we found? Surprise, surprise, Vyvanse is now being packaged at a new site.

Even more surprising, or perhaps not, the label actually has spelling errors. Yes, you heard me right. I couldn’t believe this until I saw this for myself. The label has spelling errors. One strength even misspells “pharmaceuticals” — like, really poorly — and I’m going to put this in the show notes, how badly “pharmaceuticals” is spelt.

Now let’s just take a moment to let this sink in. These are controlled substances that we have walked over broken glass, spent thousands and thousands of dollars to get. We are paying for this — and this controlled substance is packaged with typos on the labels.

Now, when I’ve contacted Takeda, which is the manufacturer of Vyvanse, this is what they’ve said. This is a quote: “These are just grammatical issues, and they do not impact the quality of the medication.”

I mean, I just don’t actually know where to start with that because if they can’t spell “capsule,” how can we trust that they’ve got the recipe right? How can we trust that they’ve got the ingredients right? But yet, we are just supposed to accept that that’s just a small error. Jeez, it’s a glaring error. Do they check anything?

Here is what the community is actually experiencing. These are real symptoms that people are reporting. Adults are saying things like, “I feel wired, but I’m also unfocused.” “I feel like I’ve not taken any medication at all, and I’ve taken a step back to two years ago.”

There’s a lot of people reporting skin picking, binge eating, jaw clenching, but yet they have no focus. People are reporting a very hard crash mid-afternoon and a total loss of emotional regulation. So for example, when you start taking medication and it starts working for you, maybe you take on more at work. Maybe you start parenting differently. Maybe you have your children more because you’re coping better.

Suddenly, you’re just way back into 2022 — that was the first time you took medication — and now you’re living the life of 2025, which you set up because you were medicated. Now you’re in the middle of a mess that you can no longer control.

Now what mums are coming to me and reporting about their children is that they are seeing an absolute regression in behaviour — meltdowns, aggression at school, dysregulation, sleep disturbance, appetite changes, extreme hunger or total loss of hunger — and then of course they are starting to see those school phone calls and emails come in.

And for a mother watching their child getting into trouble — and we won’t talk about the punishment system at schools, that’s for another episode — but a lot of these children are now back to square one where they’re getting punished. How does that even feel for them? I’ve got goosebumps because they’ve been through so much to get that medication. It’s probably taken them a long time to get that right. They’ve gotten used to the functioning, and then suddenly, they’ve taken a big step back.

We’ve got thousands all reporting the same thing, and one of the worst parts of this is that most of these children are past the review period for the medication, which means that this Vyvanse medication, for example, has now been established. Their next paediatrician appointment could be six months away in the public system.

If they’re in the private system, they may be on a wait list for a cancellation. There might be a three to six-month minimum on that because can you imagine every other mother doing the same thing trying to get their child back in for a review? Now, you may think that paediatricians, teachers, and medical professionals are going to be across this issue. The trouble is that they aren’t.

There hasn’t been a big public announcement yet, so when things go sideways, people don’t actually even think to question the medication. The teachers just think it’s behavioural or parenting. Parents just assume they’re missing something, and the kids — the kids just think they’ve failed.

They don’t know why they feel off. They just get told they’re not listening. They’re not trying. They’re being disruptive. Or maybe the Vyvanse was helping with huge amounts of anxiety, and suddenly the anxiety is back and they don’t know how to communicate it, and they carry that around without necessarily having the words for it — quietly, constantly, and probably in shame — because they don’t know what’s wrong with them.

Now, I have an email full of gut-wrenching stories of people whose lives are affected, but I don’t feel like you need me to tell those stories. You have your own stories. You ladies get it. We don’t need to hear why it’s a problem. The government needs to know why it’s a problem. Send your stories to your local MP and let them know that this is not okay.

Last year, the government’s response was just to change medications, but we can’t, because Concerta is not available. So we can’t switch back. So then what? Okay, what do we have left? Dexamphetamine and Ritalin, which are both three to four-hour short-acting doses.

The problem with these is that they spike and crash. You don’t get that same level mood for eight to twelve hours. They will wear off before lunch. You need to have a paediatrician’s letter, and if you’re separated, you need to have both parents aware of that and signing off on that for the school to be giving that second dose of medication at lunchtime — and your child has to then go attend the office to get their medication.

This is why a lot of parents move towards the long-acting. And do the schools need any more load? No, of course they don’t. And the teachers who are handling this whole thing — with a lot of parents not realising that this medication is causing side effects and not working anymore — and the teachers going, “I don’t know what’s happened here.” Nobody has an understanding about what’s happening.

This is why this public service episode needs to be shared far and wide. So this is not just a typo on a bottle. This is about bioavailability. This is about formulation integrity. This is about supply chain ethics. And this is about children who are being punished because no one thought to double-check the medication — and that’s on the government. That’s not on you, the mother. This is not acceptable. This is not okay. And I’m not going to stop talking about it.

What can we do? I am not about detailing problems and then leaving everybody stressing. I have already thought this through and I have an action plan coming.

Number one, what we need to do is we need to track symptoms. We need to start today. We need to document everything — mood, focus, appetite, sleep, school issues, side effects. And on the side of your bottle, there is going to be a batch number. You need to write down the batch number.

And I know we all have ADHD, so this is already like, “Oh god, more shit to do.” I get it. I so get it. But what we need to do is build a data trail.

If you are thinking to yourself, “Why is this back on us?” Great question. The TGA is, to their credit, actually onto it. They are investigating it, but they need more information.

I’m going to put in the show notes where you can upload and where you can report the problems with which batch. The TGA has publicly acknowledged that there are packaging errors. However, they initially stated that the medication itself had not changed. But following widespread concerns — which was mostly from social media, and you know what, I bet that was from the mums — they’ve since confirmed that they have got a very large increase in adverse event reports and they have acknowledged that there are many reports of decreased effectiveness.

So ladies, this is not us. The TGA has launched a deeper investigation, and they have stated — this is a direct quote — “We are continuing our investigations into these reports, including reports of decreased effectiveness. We are working with Takeda to obtain more information, as well as undertaking independent testing in our own laboratories. As with any medication, if we find any problems with safety or effectiveness, we will take action.”

And I’ve got a link, and I’m going to put that into the show notes. Then there’s going to be a link as well with where you can go to actually report it. Now what we need to do is we need to continue sending this through so we can figure out what batches are the issue — if any of the batches are okay — and to get Takeda to sort themselves out.

Now, frequently asked question: is there a generic brand, is there another version of Vyvanse? No. And you know what, this is actually really starting to give me the shits, because last year I found out from Takeda that they actually had a supply and demand issue.

So where they were manufacturing in the US, there were all of these restrictions around how much they could produce, and that was where the issue was. Because of the increased diagnosis and how great Vyvanse has been as a drug for so many people, Australia was one of the first to come out and say, “We just don’t have any at all.”

Now, I said at that point: manufacture it somewhere else. Where are the other companies? Surely someone else can do this. But there is a patent, and there are legalities around the particular ingredient formulation.

So at that time I was like, well, if you’re manufacturing it in the US, why don’t you manufacture it somewhere else, and then you can make more of it so everybody has enough? That was what I called for a year ago. I doubt they’ve listened to me, but I think it was a pretty obvious answer.

So someone there in Takeda has gone and outsourced the manufacturing — probably so they can create more. But this is where the issue has gone. I don’t want to say that they’ve done low cost, because I don’t know, but I am wondering if they’ve gone a cheaper place and perhaps English isn’t their first language, which is why perhaps no one has picked up the spelling errors in very simple spelling.

But my assumption is that they’ve gone and manufactured elsewhere. And I don’t want to say it, but it just really seems like whoever has been creating the actual drug has got some errors. I don’t understand how there could be so many thousands of people all saying the same thing.

So, action items — what should we do? This podcast is not about creating problems and anxiety and then not doing anything. We’ve already got enough problems and anxiety and things that we can’t change in our lives without having any more. This episode is absolutely not to scare anybody. What it is, is to let you know — if you are having issues with Vyvanse, it is not you, it is not in your head, it is not your child’s fault.

There is something going on with Vyvanse — even the TGA have admitted that — and it is being investigated. What we need to do is we need to ask loudly and together, what is going on?

I want you to go onto the show notes and hit the TGA website and write down the batch number on the label of your medication, write down the side effects, and submit it to the TGA for each medication bottle that you have that has not worked.

In your report to the TGA, I want you to directly ask them: is this batch undergoing testing? Has this formulation been independently reviewed for potency and quality? Then I want you to write to your MP, and I want you to write in there the lack of clarity around the post-shortage formulation consistency, the need for independent lab testing of ADHD medications, and the impact on children and families who are caught up in this uncertainty.

I also want you to email your paediatrician, psychiatrist, or whoever it is that you are getting your scripts from. The reason being is because I just want as many people to know about this as possible.

So if you have a paediatrician or a psychiatrist, I want you to email them the TGA link that I’ll put in the show notes. Just email it to their office. Let them know that this is happening. You would assume as the prescriber it would be the person reacting to it, it would be the environment — you wouldn’t think there’s anything wrong with the medication, would you?

Even if they say they haven’t heard about it, that’s okay, because you can actually give them the TGA website. We’re actually quoting a regulatory body who is investigating this because this is a real issue.

I want you to share this episode. Send it to your school, to your parent group, to your partner, on Facebook. Send it to anybody with ADHD. Share it across social media.

The reason is because I just would hate to think that anybody is blaming the family for what is happening with the child, or the mum, or whatever it is that you’re experiencing. This is not an us thing. This is a supply chain and formulation problem — and the more noise we make around it, the faster the TGA will act and the more pressure we will put on Takeda.

Quick PS from me — it has not escaped me that this is the final day of school. School holidays are around the corner, and a lot of us are going to be without Vyvanse, Concerta, as our children will be. I know the dread that creeps in because I get a lot of dread when I’m facing a two-week break — and that’s with medication.

Those are long days, unpredictable routines, zero structure — and then without the medication that helps your child function, and without the medication that helps you function, that helps you slow down, that helps you parent better, that helps you keep ahead of it and stay sane. For a lot of us, I use ADHD medication a lot for anxiety, and there can be a real bounce back of anxiety when the medication that you are having is no longer working or you do not have it.