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We call for urgent investment in research as report puts lifetime cost of harm caused by epilepsy medications as high as £2.5m

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Nicola Swanborough

We call for urgent investment in research as report puts lifetime cost of harm caused by epilepsy medications as high as £2.5m

A new report shows that the lifetime costs of harm caused by exposure to epilepsy medications during pregnancy could be as high as £2.5m.

That is the cost for one child exposed to high-risk drugs during pregnancy and includes costs to the NHS, education and welfare systems, the affected individual, their family and wider society. The cost to the NHS alone is over half a million.

The report from the Office of Health Economics - Individual, Health System, and Societal Impacts of Anti-seizure Medicine Use During Pregnancy - comes as the Epilepsy Society is asking the Government to fund vital research that could stop babies from being born with preventable harms caused by epilepsy medication.

The report, commissioned by the Epilepsy Society, was launched in parliament on 23 January 2024.

Clare Pelham, Chief Executive of the charity said:

“We want to make sure that any teenager who has epilepsy today will be able to plan a family in the future knowing that their anti-seizure medication will not increase the risk of harm for their baby.

“It is no longer enough for the NHS to be there from the cradle to the grave. When it comes to a complex condition like epilepsy, the safety of a mother and developing baby begins long before conception and that is where science must be allowed to pinpoint which medications are safe for which pregnancies.”

Insufficient data

Every year, around 2,500 babies are born to women with epilepsy in the UK. Data from the Commission on Human Medicines has shown that exposure to some anti-seizure medications (ASMs) during pregnancy is linked to an increased risk of physical abnormalities and developmental disorders in babies. Only two ASMs are thought to be safer in pregnancy while there is not sufficient data to say whether other newer medications are safe.

Birth defects include spina bifida, cleft lip or palate, and malformations of the limbs and organs. Developmental disorders include autism, attention deficit hyperactivity disorder (ADHD), delays in learning to walk and talk, lower intellectual abilities than other children of the same age, poor speech and language skills, and memory problems. 

IMPORTANT: You should never stop taking your epilepsy medication without consulting your doctor or neurologist. Suddenly stopping medication could result in seizures.

Substantial financial costs

The report shows that these conditions impose substantial financial costs on affected individuals, the NHS, other governmental sectors and wider society. 

According to the OHE, the total cost per case across these sectors ranges from £2.5 million in severe cases of autism spectrum disorder, to £11,000 for facial and skull malformations. The lifetime costs for a child born with spina bifida is estimated to be £927,000; for ADHD £124,000; and for speech, language and communication needs £90,000.  The authors also highlight the considerable non-monetary effects in terms of impacts on quality of life of affected children and their families.

Investment in research

The Epilepsy Society is calling on the Government to invest £20m in research into understanding the specific risks of different epilepsy medications in pregnancy.

“Every parent knows the hopes and anxiety of waiting for a baby to be born.  All anybody wants is for them to be born healthy,” said Clare Pelham.

“If you knew that a small investment of £20 million by the Government would mean that some babies would not be born with disabilities caused by their parent's medication , you would jump at that chance.

“Today’s report by the OHE spells out that not only is this investment the right thing to do.  But it is also the most efficient thing to do. Investment in life changing research would be a saving for the Government, not a cost.”

Hope of genomic research

The charity believes that, for every woman with epilepsy who is planning to have a baby, genomic research could help identify which anti-seizure medications will present the highest risk for her baby during pregnancy and which will be the safest.

Research today could prevent parents in 10 years’ time from having to make the heart-breaking choice between drugs which control their seizures but put their babies at risk of physical defects and developmental disorders, and drugs which will be safer for their babies but may leave them at risk of seizures. 

“Just £20 million would enable us to carry out research that would stop us playing Russian roulette with tomorrow’s generation,” said Clare Pelham. “If just eight children were saved from a lifetime of a severe disability, the Government would have broken even on its investment. This research is not about more public spending– it is about saving money for the taxpayer.

“Genomics could enable us to tailor drugs at an individual level, choosing the best and safest medication for a woman according to her genetic make-up. It could mean that by looking at a patient’s DNA, a clinician could confidently prescribe a high-risk drug, knowing that it would be safe for her baby while giving her optimum seizure control.”

First analysis

Nadine Henderson, Senior Economist at OHE and co-author of the report, said: “This analysis is the first attempt to assemble a detailed picture of the costs of a range of disabilities that appear to be more likely when a foetus is exposed to anti-seizure medications.

“Our findings show that the burden of even a single preventable case of a congenital or neurodevelopmental disorder can be substantial and highlight the need to improve our understanding of which medicines carry which risks in pregnancy.

This will help those with epilepsy and their clinicians to make informed treatment decisions that take into account the full range of a patient’s life goals.”

One of the highest risk epilepsy medications is valproate. Just under half of babies exposed to the drug during pregnancy are born with a physical or developmental disorder. New regulations mean that women can now only be prescribed valproate if they are part of a pregnancy prevention programme that includes effective contraceptive.

Maternal deaths

But switching a woman to a lower risk medication may mean relying on a drug which is not as effective in controlling seizures. A recent report into maternal deaths during pregnancy MBRRACE-UK’s Saving Lives, Improving Mothers’ Care 2023 report showed that from 2019- 2021 – the period in which the new regulations came in – the number of deaths due to Sudden Unexpected Death in Epilepsy almost doubled compared with the period 2013-2015.

Clare Pelham continued: “We are talking about saving women’s lives and preventing babies being born with avoidable harms, two ambitions which must be top priorities for any society that truly cares.”

Patient Safety Commissioner comments

Patient Safety Commissioner, Dr Henrietta Hughes welcomed the OHE report. “Any parent whose child has been harmed by exposure to anti-seizure medication during pregnancy will know the cost of that disability to both the individual and their family. This report makes a clear economic case for investment in research that could prevent babies being born with preventable disabilities. Such research would augment changes I have called for to monitor the prescribing of anti-seizure medicine to women of childbearing potential. I hope the government will acknowledge the long-term benefit of investment now for future generations.’

Baroness Cumberlege comments

Baroness Cumberlege, Chair of The Independent Medicines and Medical Devices Safety Review said: “First Do No Harm, our report looking at the way the healthcare system responded to reports of harmful side effects from medicines and medical devices, including valproate, found that the whole system was slow to respond to emerging data, either by regulatory action or by commissioning further research.

“The data from the CHM linking an elevated risk of harm during pregnancy to several anti-seizure medications was first published in January 2021 and it is now 2024. For three years the Epilepsy Society has been calling for more research in this area, research with the potential to stop babies from being born with preventable disabilities. I hope that the added weight of this report illustrating the financial burden of a preventable disability to families, the NHS and wider society, will result in a commitment to long overdue research in this area.”

You can access the full report here.


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