Just a quick heads up. Today's episode discusses distressing themes, including suicide. Listener discretion is advised. If you or someone you know need support. Help is available twenty four to seven through Lifeline on thirteen eleven fourteen. Already and this this is the Daily Art. This is the Daily OS. Oh now it makes sense.
Good morning and welcome to the Daily OS. It's Wednesday, the third of December. I'm Emma Gillespie, I'm Billy Fitzsimon's. Australia's Medicines Regulator has issued a safety alert for ozempic and similar drugs over a potential risk of suicidal thoughts. The updated warning follows a spike in reports of suicidal ideation linked to weight loss medications to the Therapeutic Goods
Administration the TGA. Today, we are going to explore what led to this moment and what it means for patients and everything else that you need to know in between.
And when this came out on Monday, I believe it was. It was so interesting and I immediately thought of you because you have spent most of this year looking into weight loss medication, looking into ozen pic. I'm sure many of the people listening to this episode have probably listened to your investigation into ozen pic. Yeah, if you haven't,
we will link it in the show notes. But before we get into what the announcement on Monday from the TGA was, do you want to just kind of give us the lay of the land about what I know, I'm referencing just ozen pic, but I know it's much broader than that. How long it's been around all of those kinds of details.
Yeah, of course. So ozen Pic, as you mentioned, is the big one. It was first approved by health authorities here in Australia as a medication to treat type two diabetes in twenty eighteen. Now, Ozempic is a brand name for a drug otherwise known as semaglue tide and that falls into this family of drugs called glp ones. So you'll often hear these drugs described as glp ones or
as ozenpic as kind of a captural phrase. But they are taken as an injection, usually once a week, and they start working almost immediately within hours in some cases. Ozenpic is the name that gets talked about so much in the media, but there are now some very popular alternatives. We go vi, Munjaro, Saxender that you might have heard of, and they all work in the same way. So glp ones act on hormones in our body, and for patients with diabetes, they make sure that their cells work better
with insulin. But also, and importantly, these drugs slow down what's called gastric emptying, so in other words, you feel fuller faster. That is the side effect that has meant these drugs have become increasingly popular for weight loss. And you know, we've seen the kind of global surge, They've become viral, the kind of butt of celebrity jokes almost, and that's pretty much the lay of the land. In as short of as summary as I can give you on the world of glp.
Ones, I'm interested in how popular they have become because I think, you know, if we go back three years when I feel like we were all kind of first hearing about it, maybe not even three years ago, maybe two years ago, it felt like something that I mean, I didn't know anyone who was on it. And now just anecdotally, I think that I hear of a lot more people who don't have type two diabetes who are on it. It does feel a lot more common. Do we know exactly how popular they are?
Yeah, they have really shifted into the mainstream. I think four or five years ago we heard about ozepic. Is this kind of celebrity joke or you'd hear about celebrities being quote unquote on it, But it wasn't really in our backyard or in our faces and in our world.
But that has shifted in recent years. So Ozepic is a PBS listed drug four type two diabetes treatment, meaning if that's why you take it, it's subsidized by the government, costs about forty bucks a month and PBS scripts are tracked, but GLP one prescriptions for any use other than type two diabetes treatment aren't tracked. So if you are taking glp ones for weight loss you don't have diabetes, that's a private prescription. We have no way of knowing how
many people are doing that. It's virtually impossible to determine the scale of GLP one use. It also means that most people who use them are spending up to four hundred dollars a month to access them because they're not subsidized. Now globally, we know there has been a surging demand for these drugs it's created shortages, supply chain issues, and
that demand has also made pharmaceutical companies very rich. Just a few weeks ago, Eli Lilly, that is the manufacturer of Munjaro, became the first drug maker to reach evaluation of a trillion US dollars. It's about one and a half trillion Aussie dollars.
Yeah, I saw that, and I think it does speak to just how popular this is becoming for private use. I want to talk a bit more about side effects, because that is what the TGA talked about in their announcement on Monday.
Yeah.
Before we get to that specific announcement, though, what are the common side effects that we know other than weight loss?
Yeah, So while we don't know how many prescriptions of GLP ones are issued in Australia, we do know the kinds of negative side effects that are being reported. And that's because GPS and healthcare providers can report adverse side effects relating to GLP ones to the TGA. So there's this Adverse Event Notifications database that those reports are listed
on that anyone can publicly see. Now. Between July twenty twenty three and July twenty twenty five, the database shows that gastro Intestinal disorders were the most frequently reported side effects associated with semaglue tides, so that include odes, nausea, vomiting, cramping, constipation, pancreatitis. Those complaints make up around half of all negative side
effects on the database relating to these drugs. But another really concerning one that has emerged is suicidal ideation, so that makes up one in every twenty adverse GLP one reactions reported to this database. In the two years to July twenty twenty five, there were seven deaths linked to psychiatric disorders and GOLP ones. Ozenpic was the only product suspected to be related to two deaths by suicide in
that period. But the TGA does note that it uses these reports to identify when a safety issue may be present. It says, assessing the safety of a medicine quote cannot be made using the tracker alone.
Right, And I remember from your investigation into Ozenpic that you actually spoke to someone who had experienced suicidal adiation whilst on ozeen Pic. What can you tell us about that conversation.
Yeah. I interviewed Mackenzie earlier this year. She is a twenty six year old who sought out ozen Pick for weight management through Juniper. Now. Juniper is one of a growing number of online platforms that prescribed weight loss medications without requiring in person consults. You've probably seen their ads or heard from them in some way on your social media feed. They are a massive company, and Mackenzie disclosed to them that she had been taking antidepressants since her
early teens, so she had a history of depression. But she was approved to use Ozeenpick by Juniper. Here is a little bit about her story.
So I guess for me, I kind of had peace of mind that it would cover everything that was in my medical history. So I started receiving that in the mail and injecting that as per kind of the recommended gidelines. I, for no reason whatsoever, and I hadn't felt like this for a very long time, became unable to work. It was really quite unexplained. I was really really concerned, and I chatted with my partner about it, and he was like, well, the only thing that has changed in your life is
you going on this particular medication. So Mackenzie has a long term history of depression which was being managed by her antidepressants, but then she started on ozen pic and then began experiencing suicidal ideations essentially out of nowhere.
Yeah, exactly, And so she expressed her concerns to her regular GP, so not who she was prescribed the golp one through, and he told her that he'd actually seen this in a number of patients. His explanation was that golp ones slow the digestive system and as a result, they can have a negative effect on the absorption of other drugs. So if you're taking other medications whilst you're injecting ozepic, maybe it will influence how your body absorbs those other meds.
So ozempic potentially stopped her body from absorbing the antidepressants that she had been on for the past decade.
Yep.
That is basically what her doctor explained, and so Mackenzie ended up being in such a bad place her GP suggested she go to the hospital stop taking oze pic immediately. I did ask her about the kind of information that she was given by Juniper at the time. She said she thoroughly interrogated all of it, and the resources at that time did not explain anything or flag anything to do with mental health. So she never held that as a concern when she started taking.
Oceepic, and did mackenzie speak to Juniper the prescriber about the suicidal ideation.
So she did tell the provider that her doctor had advised her to stop taking ozmpic. She explained the side effects that she had been hospitalized, and the response that she told me she got was basically, well, that's not a listed side effect. It shouldn't affect your antidepressant absorption at all. TDA put these can concerns to Juniper earlier this year, and they dispute any relationship between these medications and an increased risk of mental health related side effects.
The clinical director of Juniper, doctor Matt Vickers, cited specific guidance from the UK Health Regulator, which stated in September twenty twenty four that the available data does not support a causal association between JLP ones and suicidal ideation. Vickers also pointed to some data from the US mind you.
This was a preliminary evaluation of an ongoing study by the Food and Drug Administration, which said last year that it didn't find an association or clearly demonstrated relationship between GLP ones and the occurrence of suicidal thoughts. However, an analysis of adverse reactions within the World Health Organizations Global
database painted a different picture. Findings from an international study published in August actually identified a disproportionate link between suicidal ideation and these medications.
Okay, so what I'm hearing is there was not a lot of evidence at the time when we were looking into this about the link between suicidal ideation and taking GLP ones, saying that the WHO, the Weld Health Organization did say that there was a possible link. But then on Monday, the TGA, which is Australia's medical regulator, came out and said that this link between GLP ones, which is ozen pic and suicidal ideation is a bit more clear.
Now, yeah, there has been I suppose a lot of contradictory information. If you wanted to argue either way, you could kind of cherry pick some data to reflect that. But what has been in black and white is that database, the adverse event database that the TGA publishes, which shows us an increase and frequency in suicidal ideation being reported. We had that global data from the WHO, and now we have an update from the TG. So on Monday it released advice on GLP one's warning about the potential
risk of suicidal thoughts. The regulator said that patients taking these medications should quote tell their health professional if they experience new or worsening depression, suicidal thoughts, or any unusual changes in mood or behavior.
So what does this mean in practical terms for anyone who is taking it and is now concerned, or if you know someone who's taking it, yeah, atn't concerned.
The biggest immediate change is that there's going to be labels now on GLP one, so all GLP one medications will note the risk of suicidal thoughts or behaviors. But I also think what is really significant about this announcement is it sends a really important message to patients who have felt ignored to be honest or even gas lit by the system by prescribers who have kind of downplayed
their experiences. If you are someone taking GLP ones and you are worried about this, it is a small percentage, So I would say, you know, there's no need to immediately be alarmed if you don't have a history of mental ill health, or if you are feeling a certain way and maybe you have been doubting yourself. I think that this is really affirming to tell patients to, you know, trust themselves. Now, given this update, this new advice from
the TGA, I reached out to Juniper again. A statement from doctor Matt Vickers, their clinical director, said that the TGA's recent updates to GLP one product warnings reflect the outcome of a review after what it called isolated reports of suicidality quote. As with reviews by other global regulators, no causal link has been found between GLP ones and suicidal or self harming behavior. So they said that they caution patients about the potential risk, and that they have
done since the service was established. However, that contradicts I suppose what we have heard from some of them former patients. And finally, Junipers said, with millions of people now treated with GLP ones globally quote, the safety profile has continued to strengthen. Interestingly, the TGA also said on Monday that it couldn't rule out whether Munjarro, one of the popular GLP ones, reduces the strength of the oral contraceptive pill.
We had heard a little bit about this before from previous studies from other health bodies, and now the TGA is advising that patients use non oral contraception for four weeks when starting munjarro and four weeks after increasing their dosage. So they're basically saying, give yourself a bit of a four week window if your intake changes or when you start the drug to ensure that you're protected. So, for example, user condom for four weeks.
Interesting and just quickly before we wrap up, I also saw that there was another big announcement from the WHO this week about GLP ones.
What was that, Yeah, it's been a big week for GLP ones, Billy. The WHO has released new guidelines on the use of GLP ones for the treatment of obesity in adults. Now, this is a global framework that acknowledges a need to treat obesity quote as a chronic, relapsing
disease rather than a lifestyle choice. So just quickly, the WHO said, while medication alone won't solve this global health crisis, GLP one therapies can help millions overcome obesity and reduce its associated harms as part of a comprehensive approach that includes healthy diets, regular physical activity, and support from health professionals.
Now it's significant because this is a global Health body basically endorsing or recommending GLP ones as an obesity treatment and also formally recognizing obesity as a chronic disease associated with high numbers of deaths a high economic burden on health systems. Now, look, it does solve the issue of suicidal ideation, of long term side effects and concern around
mental health impacts. But if there is a global health body saying we need to take this treatment really seriously, saying that it is critical to solving the obesity crisis, I think that means we will see a lot more investment in understanding these side effects. So with more attention will mean more funding, more research, more transparency, and hopefully that will give patients a clearer sense of side effects and some more answers around the suicidal ideation piece.
I mean, you said before that these medications have really only been around since twenty eighteen, So the fact that it is constantly changing and there is still new research still coming out about it, it does make sense given how new it is.
Yeah, exactly, and we will continue to learn more as time passes, and you know, as the global conversation continues.
Thank you for taking us through it, M and for all of the work that you've done this year on looking into it. What a timely announcement from the TGA. Thank you so much, Billy, and thank you so much for listening to this episode of The Daily Os. If you've got a personal story about GLP ones that you want to share with us, we would love to hear from you. You can dm us on Instagram at any time or send an email to helloatthdalilyos dot com dot au.
And just a reminder that if this episode has raised any issues for you, you can contact the lifeline on thirteen eleven fourteen. We'll be back this afternoon with your evening headlines, but until then, have a great day.
My name is Lily Maddon and I'm a proud Aarunda Bungelung Caalcutin woman from Gadigol Country.
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