‘It’s actually dangerous’: Why Australia won’t follow UK epilepsy drug rules

His story has taken lost of twists and turns, including the odd period when medication has worked and his seizures have been few and far between. At one stage, his attacks became so infrequent he was even able to get his driver’s licence. But after each good spell has come something that is inevitable for him; his medication fails.He has no memory of the seizures themselves but describes the lead-up to one as feeling like being claustrophobic in a room as the walls start to shrink inward. His senses become heightened, so too does his anxiety and there’s a physical sense he can’t quite articulate, but it is not something he likes the feeling of.

The next thing he is aware of is when his consciousness starts to return, but brings with it a sense of exhaustion.

It means his seizure is over or nearing its end.

Mezger has complex focal seizures which involve a disruption to consciousness and awareness. Sometimes they are so subtle that people would barely notice. “They probably just think I’m spaced out,” he says.

He has, however, seen videos of himself having one and it makes for confronting viewing.

“I felt ashamed. It was embarrassing. It’s a hard life to live to be honest with you,” he says.

“I was scared because essentially I am somebody else; it’s like someone comes and takes control over your body and you have no control. That’s the reality of it.”

Mezger has treatment-resistant epilepsy, a condition believed to affect about 30 percent of epilepsy patients.

He was diagnosed with the subcategory after having a serious reaction to a medication that, until landing him in hospital, had worked well to control his seizures. Since coming off it, no other drug has been effective.

That drug was sodium valproate, sold as Epilim in Australia.

“I basically ended up with drug-induced liver hepatitis,” Mezger says.

He was taking two medications at the time and was then taken off the drug.

Despite his poor experience, he does not think it should be restricted for use, even taking into account the known health warnings that come with it.

But in Britain, that is exactly what has been happening in recent years, and it has created lots of division.

There are also advocates in Australia who want tighter restrictions around the prescribing of the drug because of the risk of side-effects.

What is sodium valproate?

Sodium valproate is a highly effective anticonvulsant prescription drug that has been used to control seizures since the 1960s.

It is a particularly effective broad-spectrum anti-seizure medication, meaning it can be used for many types of epilepsy, including tonic-clonic seizures, which are the ones characterised by a loss of consciousness and violent muscle jerking.

In rarer cases, the medication is used in some countries to prevent migraine or for bipolar disorder.

However, the medication is associated with an increased risk of birth-defects when a woman takes it during pregnancy or up to three months prior to conception. In Britain, thousands of babies are believed to have been born with defects to mothers who took the medication during pregnancy; many later said they were completely unaware of the risks.

While concerns about those potential side-effects were suspected for decades, patient advocates have long said they were often dismissed and the risks downplayed.

However, that has changed in recent years.

According to the Therapeutic Goods Administration, it is “well known” that valproate can cause malformations and neurodevelopmental disorders in babies born to women who take valproate before and during pregnancy.
“Because of this, women and people who can give birth to children are advised to avoid taking this medicine at those times,” the TGA recommends.

“A recent European study has now suggested that there may also be an increased risk of neurodevelopmental disorders in children where the man involved in the conception has been taking valproate in the three months before the pregnancy happened.”

However, Australia’s drug regulator states there is no proof the drug has caused such problems in children conceived by men who take the medication and that it has not received any reports of such a thing happening domestically.

Regardless, the drug’s manufacturer has now added a warning to the medication, which is what prompted the TGA to publish its own caution.

The change has been prompted by what has been happening in Britain. There, the drug is now significantly restricted for both men and women of child-bearing age. Restrictions have been in place since 2018 for females of child-bearing “potential”, requiring them to only be prescribed the drug if they are part of a pregnancy prevention program or if no other effective treatment option is available.

Pregnancy prevention programs require the use of highly effective long-term contraception such as a copper intrauterine device or levonorgestrel intrauterine systems, a contraceptive implant or sterilisation.

Further restrictions were introduced in 2024 in Britain stating that men and women under the age of 55 should validate with two specialists who independently agree toit being prescribed.

Women already taking the drug and wanting to keep taking it were also required to get two specialists to sign off on it. Later, that rule was extended to men in the same age group.

Britain’s National Health Service states “if taken during pregnancy, sodium valproate can cause problems for a baby’s development, including birth defects and lifelong learning difficulties”.

“Sodium valproate is not recommended if there’s a chance that you could become pregnant,” it states. “For men taking sodium valproate, your fertility could be affected. It may also cause learning or behavioural problems in your child if your partner becomes pregnant while you’re taking sodium valproate.”

However, all patients are strongly advised against stopping any epilepsy medication and to only do so under the supervision of a specialist.

The changes were prompted by the findings of a retrospective observational study of birth data from three Nordic countries. It suggested an increased risk of neurodevelopmental disorders in children born to men who had been taking sodium valproate in the three months before conception, when compared to children born to men treated with lamotrigine or levetiracetam.

“The study found the cumulative risk of NDDs was estimated at 5 per cent in children of fathers taking valproate compared to 3 per cent in children of fathers taking lamotrigine or levetiracetam,” a position statement released by the Epilepsy Society of Australia states.

Lisa Todd is a clinical nurse consultant with Epilepsy Action Australia and says there is a general sense that those findings are “relatively weak”. Ms Todd says she is opposed to any blanket bans on medications. Such moves, she believes, limit a patient’s right to make an informed decision about their healthcare.

Professor Ernie Somerville is the director of the Comprehensive Epilepsy Service at the Prince of Wales Hospital in Sydney and a conjoint professor at the University of NSW.

He too is cautious about the situation internationally, and says subsequent reviews of similar data have failed to draw the same conclusions.

It makes him question the accuracy of the report which he says was not peer reviewed and has since been found to contain errors.

The study was conducted after an earlier investigation into women who took the drug prior to and during pregnancy.

“What’s behind it is the realisation that kids born of mothers who take valproate during pregnancy have an increased risk of adverse effects,” Professor Somerville says.

“They are either malformations, so that means the baby’s body hasn’t developed properly, and that can be a range of things, the most serious of which is spina bifida.

“Recently, it’s been found that children whose mothers took valproate during pregnancy have a lower IQ by about 10 points and have an increased risk of autism and learning disorders.”

But he says some important contextual information appears to have been overlooked, such as the role of the drug’s dosage.

“The malformations in women taking valproate depend very much on the dose, which is another thing that’s not appreciated and completely ignored in these guidelines,” Professor Somerville says.

“It makes an enormous difference – what dose you’re on. If you’re on a low dose, the risk is not that much higher than it is for high doses of the alternative drugs.”

He warns some patients could die if they are prevented from using what may be the only drug that works for them.

Restrictions labelled ‘dangerous’

Professor Somerville thinks Britain’s decision to restrict the drug so significantly is an “extremely inappropriate” move. “It’s actually dangerous,” he says.

“It is the only drug that will completely stop tonic-clonic seizures in a fair number of people. One of the risks of inadequately treated tonic-clonic seizures is sudden death.

“This happens where a person is usually found in bed in the morning having died overnight during sleep. It can happen to anybody with epilepsy, but it’s rare. But there are some things that make it more likely, and one is tonic-clonic seizures.

“Normally, you treat people with the drug that you think is going to work the best …in this case, people like the British authorities are saying, ‘Well, we actually don’t want you to use the drug that you think is the best drug for stopping this person’s seizures,’ and that’s a bit of a problem.”

He argues that patients deserve the right to be made aware of the risks, discuss them with their specialist, and together decide what is best for them and their own circumstances. Pregnancy, Professor Somerville says, can be a particularly challenging time for people with epilepsy because of the dangers posed by seizures.

It is not, in his view, a situation where a blanket rule should be applied.

He has previously written about three cases where women changed medications for pregnancy but then experienced seizures that led to harm. The most alarming was a woman who had a seizure days after giving birth. She was still in hospital when she had the seizure and was found confused, with her head injured, and her baby dead on the floor.

Such incidents, while rare, point to the reality of a complicated and highly emotive situation confronting doctors and patients. The broader debate also highlights why informed consent is a legal requirement.

Will Australia follow the UK?

As noted, the drug’s manufacturer wrote to Australian authorities requesting to update its Product Information sheet to include the risk of neurodevelopmental disorders in children born to males being treated with valproate.

The changes were agreed to and in March, the TGA published its safety alert.

In a statement to The Australian, a representative for the Department of Health, Disability and Ageing said the move was precautionary.

“While there have been no reported events in Australia, the sponsor based their PI update on evidence from a European study,” the representative said.

“Other sponsors of valproate in Australia will also be adding these warnings to their PI and CMI (Consumer Medicine Information) documents for consistency.”

Professor Somerville is critical of that decision by TGA though, given the limitations of the study and a lack of consultation with groups with a knowledge of the condition and drug in question.

“They didn’t ask the Epilepsy Society or the Australian, New Zealand Association of Neurologists,” he says. “We protested once this came out and they essentially told us to go away.”

Ms Todd deals directly with patients and doctors and agrees.

“Doctors feel (the TGA decision) was a bit premature, because the evidence isn’t strong enough. There’s no direct causation,” she says.

Because sodium valproate is such a highly effective medication for some people, going off it may require a patient to then take multiple other types of anti-seizure medications to get similar results. However, Ms Todd warns that mixing medications can sometimes exacerbate other types of seizures, and in some cases, result in treatment-resistant epilepsy. The type Mezger has.

“That’s why it’s really complex, and it’s different for each person,” she says.

“That’s how they tip into the drug-resistant epilepsy and they may need to go down the track of actually considering other treatments, like they may need to have surgery if there’s an identifiable area of the brain that needs to be removed.”

Data from the health department shows that between 1980 and August 2025 there have been a total of 170 adverse event reports listed in the Database of Adverse Event Notifications relating to sodium valproate and valproic acid, and the medical search term “congenital, familial and genetic disorders”.

Reporting of an adverse event to the TGA, or publication in the DAEN does not necessarily mean that a causal link with the medicine is established.

Some patient groups worry that Australia’s prescribing rules do not go far enough to protect children and they argue that restrictions are needed.

However, that is not something that is likely to happen any time soon.

Australia’s Advisory Committee on Medicines has met to discuss the changes to prescribing in Britain, and whether changes are necessary here, but ultimately decided against doing so.

“The ACM advised there has been no real change in the risk profile to children following maternal exposure since this issue was last reviewed by the TGA in 2018,and that there was insufficient evidence to implement prescribing restrictions for sodium valproate,” the health department representative says.

“The TGA is not currently considering any regulatory actions that might restrict prescribing of sodium valproate.”

Patients facing anxiety and depression

At the centre of all of this, of course, are patients.

This year, Epilepsy Action Australia released the results of a survey it conducted showing that many people living with epilepsy reported having high levels of anxiety and depression. That is a particularly concerning finding because those conditions are linked to stress, sleep deprivation and exhaustion, which are all triggers for seizures.

About 20 per cent of survey respondents self-reported living with depression. That’s double the rate for the broader population. Meanwhile, about one in six reported living with anxiety and more than half said their quality of life was “low-to-average”.

Mezger is not surprised by those findings.

He says having epilepsy, especially a treatment-resistant version, can be isolating because it is so poorly understood by society and people can find it confronting to deal with someone who has the condition.

He has found it difficult to hold down a corporate job because he is not able to sit in front of a screen for long periods of time and feels he is seen as a liability for many workplaces.

For now though, he is happy to continue with his modelling work and completing academic studies.

He has hopes, too, for future medical advances that could one day lead to an effective treatment for people like himself.

At one stage, he did look quite seriously into having brain surgery and even took the initial steps required, the markings of which are still visible on his skull. But it became too confronting and he ultimately decided against it, at least for now.

Instead, he is now exploring more alternative options, including changes to his lifestyle and diet, to see if they have any impact. It’s a decision he is making for himself and his health, and one he is happy with.

“I’d rather just live the way I’m living right now,” he says.

For support, patients can contact the National Epilepsy Line on 1300 374 537.