Sodium valproate scandal: How an epilepsy drug created a generation of disabled children

Read time: 8 mins

In brief…

• Sodium valproate has caused serious health problems – physical and mental – in thousands of people. The government is fully aware, but has done nothing to compensate people affected.
• One mum of two affected children tells The News Agents that no amount of money can undo the damage done to her family by the side effects of the drug.
• Health secretary Wes Streeting called for government action while Labour was in opposition, but has done nothing since winning the 2024 General Election.

What’s the story?

When Janet developed epilepsy in puberty, she was prescribed the drug sodium valproate, widely considered an effective treatment for many sufferers, in 1985.

But she was never told of the side effects the drug could bring. Not for her, but for any children she had in the future.

Both of Janet's children, Lee and Phillip, were diagnosed with fetal valproate spectrum disorder at a young age.

Lee suffered from scoliosis, resulting in curvature of the spine, while Philip suffered more extreme and diverse symptoms, including an early diagnosis of dyspraxia, and Jeannete describes his experience as having had "everything" thrown at him as he grew up..

"The drug itself never really suited me, and rather than change and try different medication, the dose just kept on going up," she tells Lewis Goodall on The News Agents.

"Did it help? Not really. The more they upped the dose the worse the side effects were."

The drug has been compared to the thalidomide scandal of the 1950s and 60s, where a drug was given to women with morning sickness, resulting in babies being born with physical deformities.

Many people have taken sodium valproate without experiencing side effects.

After giving birth to her two sons Janet was informed by a geneticist in the early nineties that the only logical cause for their range of issues was sodium valproate.

And while she admits she was warned she may experience side effects from the drug herself when she was prescribed it, she was never told it could impact her children.

Sodium valproate is now only prescribed to people in very rare circumstances, and changes introduced in January 2024 meant that people already taking the drug would have their medication reviewed, and could only continue after a second opinion on the risks was obtained.

The drug was first developed in 1962 and it's believed that doctors were aware of its impact on pregnant women since it was first prescribed. It has been prescribed in the UK since 1973, and warnings have been included on patient information leaflets since 1994.

Sodium valproate carries between a 30 and 40% risk of causing developmental disorders and a 10% risk of serious birth defects in babies. These can include autism, ADHD, learning disabilities – and Janet has encountered people born with spina bifida and cleft lip and palate due to their mother's prescription.

It is estimated that more than 20,000 children have been affected.

Lack of action blamed on ‘failure of the state’

Sean Linson, health editor at The Times newspaper, has been reporting on the impact of sodium valproate for many years and says the failure lies solely with government and health authorities.

"It is important for people to understand this generation of disabled children that we've created in this country was entirely of the state's doing," he says.

"It is a failure of state that these families are in the position they're in."

Many of the families affected he has met are living on low benefit payments, and feel guilt for the situation they are in.

Janet says this is something she has experienced raising Lee and Philip.

"The guilt stays with you," she says.

"It's because you took that drug that your children have been affected and that never, ever leaves you at all."

Sean, and The Times newspaper, is calling for compensation to be given to people who have suffered because of the drug, who are now aging and face an uncertain and insecure future when their parents are no longer around to care for them.

"You could argue that at that point the evidence was limited – there was some evidence in animal studies, and I think there should have been a precautionary principle there, but they decided not to warn families," he says.

"But then I think they made another serious error, which was despite that warning, they then didn't commission any long term study to double check if those warnings became true.

"For the next 30 years, we had no one looking at the impact of this drug on whether it was actually affecting babies. In fact, that problem persists today – we're not doing those long term studies to look into the safety of some of these drugs."

He believes the reason for the lack of studies, even today, is due to cost and the long-term nature of the drug and its impact, making it more difficult to assess due to many external factors.

Janet believes there is concern among medical professionals about how patients with epilepsy could be affected if they suddenly stopped taking the drug, as it has proven to be effective in treating the condition.

What have governments done to address the situation?

In 2015, the Medicines and Healthcare product Regulatory Agency (MHRA) issued a 'valproate toolkit' to doctors – but warning patients of the serious side effects was not mandatory, and many healthcare professionals failed to do so.

In 2020, the Cumberlege Review, which looked at how the NHS responds to reports from patients about side effects from treatments including sodium valproate, was set up, and called for a compensation scheme for victims. This has still not happened, despite the issue having been discussed in the House of Commons under the previous Tory government.

A Patient Safety Commissioner was appointed, Professor Henrietta Hughes, who tells The News Agents that doctors who did not warn patients about the long term effects of the drug were making a decision for the safety of their immediate patient, and disregarding the health and lives of their potential offspring.

She says the only major change brought about since the Cumberlege Review is a law ensuring all drugs be given to patients in their original packaging, which includes warnings of possible side effects.

Sean Linson says the problem is systemic in the NHS, which he believes is unable to properly address its own failings.

"I think there's a protective sense of their little bit of the system, the status quo as they experience it," he says.

"It shouldn't take the pain, suffering and gargantuan effort of victims of these state failures to get justice.

"We could get progress as a country and move forward faster and better if we were more responsive to some of these things and actually learned the lessons, rather than just saying we had."

Victims believe compensation is ‘unlikely’

In 2024, as shadow health secretary, Wes Streeting called for swift government action on cases such as the sodium valproate – but since Labour came to power in July last year, has done nothing to make this a reality.

Another person with a family affected by sodium valproate is LBC presenter Martin Stanford. While the drug was successful in treating his wife's epilepsy, it resulted in their son Bill being born with autism.

He says his family has given little thought to any chance of compensation, believing it to be an "unlikely" scenario under current conditions.

This, he believes, is because the difference between those affected by sodium valproate, compared with thalidomide, is often less visible – and he says the government has been silent on the issue since coming to power.

"When this kind of issue comes up, you do wonder, why do people support you when they're in opposition, and why do people support you when they're a constituency MP, and yet, when they receive high office, suddenly that support seems to evaporate," he says.

"Was appointing a Patient Safety Commissioner a cynical move to push debates like this further down the road? Baroness Cumberlege did a great job in looking into this and concluded that payments should be made," he says.

"Then they put that on the shelf and say we need a Patient Safety Commissioner. Was that just an invention, just to introduce delay? I don't know.

"I think Henrietta Hughes is a genuine person doing a generally good job. She says compensation should be paid. In opposition Labor said compensation should be paid. Wes Streeting, it's over to you."

Compensation for situations of a similar scale – such as the highly publicised Post Office scandal – has run into billions, and these calls for payouts come at a time when the government has implemented widespread cuts for pensioners, people on benefits and more.

Labour ‘carefully considering’ recommendations for those affected

A government spokesperson has told The News Agents it aims to provide an update for people affected at the "earliest opportunity."

"The harm caused by sodium valproate continues to be felt today," they say.

"Our sympathies are with those affected, and we are fully focused on how best to support patients and prevent future harm. This is a complex area of work, and government is carefully considering the patient safety Commissioner's recommendations in full."

But for Martin, the time taken in making any progress is a deeply concerning issue for his family.

"While I'm still around, we can do our best to look after Bill, but we won't be here forever," he says.

"His brothers will help him. I know they will, but it shouldn't be down to them."

And for Janet, no matter what the outcome of further reviews and any government action, the damage has already been done.

"It's something that's never gonna go away, and no amount of money is ever gonna take that away," she adds.

Listen to the latest episode of The News Agents.