‘Poisonous’ epilepsy drug has left children with autism

Three mothers are speaking out after claiming a ‘poisonous’ epilepsy drug has left their children with autism, learning difficulties and incontinence after doctors failed to warn them of its risks during pregnancy.

Sodium valproate controls electrical functions in the brain to prevent life-threatening seizures, with Epilim typically being a go-to brand in the UK and Ireland.

Around 20,000 children in the UK have been affected by the drug, according to campaigners. 

NICE data reveals the drug raises the risk of babies suffering serious developmental disorders by up to 40 per cent and malformations, such as cleft palates or lips, by 11 per cent, if it is taken during pregnancy.

In September last year, campaigners presented evidence to a hearing of the European Medicines Agency in London, revealing that drug regulators knew of the problems as far back as 1973 but did not add warnings to packaging until 2015.

Last week it emerged a professor from the University of Liverpool is studying a boy affected by sodium valproate syndrome to determine if he developed the condition as a result of his grandmother taking the drug during pregnancy.

FACS Aware, which campaigns for sufferers of foetal anti-convulsant syndromes, is fighting for all drugs containing sodium valproate to have a picture warning against their use during pregnancy on their packaging, as well as increased support for sufferers and better awareness among healthcare professionals.

In an exclusive for MailOnline, three women discuss how their children’s conditions have affected their daily lives and their anger towards drug regulators.

Mother-of-two Samantha Luton-Hughes has battled depression and spent years blaming herself after both of her children (pictured with daughter Phoebe, five) suffer severe learning difficulties, which she believes is due to her taking sodium valproate during her pregnancies

Louise Duffy (right), 35, is ¿furious¿ after sodium valproate has left her  daughter Kerry (left) with autism, learning difficulties and  incontinence (pictured with her son Harry, now two)

Louise Duffy (right), 35, is ‘furious’ after sodium valproate has left her daughter Kerry (left) with autism, learning difficulties and incontinence (pictured with her son Harry, now two)

Mother-of-one Natasha Mason (pictured with her son Alfie, now three, and his father John Salwood, 28) wants to see sodium valproate banned after believing it has left Alfie with severe autism and learning difficulties, as well as being unable to speak

Mother-of-one Natasha Mason (pictured with her son Alfie, now three, and his father John Salwood, 28) wants to see sodium valproate banned after believing it has left Alfie with severe autism and learning difficulties, as well as being unable to speak

Mother-of-two spent years blaming herself after both of her children battle severe learning difficulties, which she believes is due to the ‘poison’ drug

A mother-of-two has battled depression and spent years blaming herself as she believes both of her children suffer severe learning difficulties due to her taking sodium valproate during her pregnancies.

Samantha Luton-Hughes, 41, from Worcestershire, claims she was given no information from her doctor on the medication’s risk of serious disabilities during either of her pregnancies, resulting in her children Logan, six, and Phoebe, five, enduring ADHD, heart murmurs and hernias.

Unsure of her children’s future, Ms Luton-Hughes, a self-employed beauty therapist, is ‘fuming’ at the drug regulators who reportedly knew of sodium valproate’s risks for decades.

She said: ‘I have gone through hell. As a mother I blamed myself for taking the medication.’

Despite the havoc sodium valproate has wrecked on Ms Luton-Hughes’ life, she is still forced to take the medication to control her epilepsy.

She said: ‘Every single day I feel like I’m taking poison but if I know if I don’t take it I will have a seizure and I can’t run that risk.’

Ms Luton-Hughes claims she was given no information from her doctor on the risk of serious disabilities during her pregnancies, causing her children (Logan, six, and Phoebe, five, pictured with their father) to suffer ADHD, heart murmurs and hernias

Ms Luton-Hughes claims she was given no information from her doctor on the risk of serious disabilities during her pregnancies, causing her children (Logan, six, and Phoebe, five, pictured with their father) to suffer ADHD, heart murmurs and hernias

She claims an epilepsy consultant has since told her not to take valproate in pregnancy

She claims an epilepsy consultant has since told her not to take valproate in pregnancy

HOW MANY CHILDREN SUFFER? 

Out of around 35,000 women aged 14-to-45 taking sodium valproate between 2010 and 2012, at least 1,125 were pregnant.

If 450 babies are born every year to mothers taking the drug, up to 45 could have a physical disability and up to 180 may suffer from learning difficulties. 

Between 1993 and 2008, there was a 20 per cent reduction in the number of women aged 15-to-55 who were taking sodium valproate due to new treatments being available.

The Medicines and Healthcare products Regulatory Agency says sodium valproate should not be given to women of a childbearing age or during pregnancy unless alternative treatments are ineffective or not tolerated. 

Yet, in 2016, around 450 babies were born to mothers taking the drug during pregnancy. 

Source: Epilepsy Society 

‘You must come off this medication if you want children’ 

When Ms Luton-Hughes became pregnant, she claims doctors only warned her about sodium valproate’s association with cleft palates or lips, without mentioning any mental side effects.

Her specialist epilepsy consultant has since said to her: ‘you must come off this medication if you want more children’. 

‘I have to apologise to people for their behaviour’ 

As well as having to cope with life-threatening epilepsy, Ms Luton-Hughes struggles to manage the demands of raising two disabled children, which often makes her feel trapped in her own home.

She said: ‘They have no awareness of safety, they aren’t very good in social situations, they have meltdowns. I feel I have to apologise to people for their behaviour so we tend to stay in a lot.’

Ms Luton-Hughes is also concerned about her children’s future as doctors are unable to give her any sort of prognosis, saying: ‘It’s very worrying. I have no idea of their life expectancy.’ 

‘I feel like I’m taking poison’ 

Amid claims drug manufacturers and regulators knew of sodium valproate’s risks, Ms Luton-Hughes, said: ‘I have gone through hell. As a mother I blamed myself for taking the medication.

‘Every single day I feel like I’m taking poison but I know if I don’t take it I will have a seizure and then I’m not going to be at my best for my children; I can’t run that risk.’ 

Ms Luton-Hughes claims her children have meltdowns and struggle to cope in social situations

Ms Luton-Hughes claims her children have meltdowns and struggle to cope in social situations

Despite Logan being born with a heart murmur, she was not told of the condition's link to sodium valproate and therefore continued taking the drug while pregnant with Phoebe

Despite Logan being born with a heart murmur, she was not told of the condition’s link to sodium valproate and therefore continued taking the drug while pregnant with Phoebe

TIMELINE OF EVENTS FIGHTING TO STOP THE PROBLEM 

In 2014 The European Medicines Agency agreed to strengthen warnings and restrictions on sodium valproate’s use in women and girls.

The Medicines and Healthcare Regulatory Agency (MHRA) advised healthcare professionals not to prescribe the drug to females unless other treatments are ineffective or poorly tolerated. 

On February 8 2016, the MHRA launched a toolkit to help healthcare professionals talk to women with epilepsy about sodium valproate’s risks during pregnancy. 

Prominent written warnings were also added to the drug’s packaging in 2016.

On April 6 2017, NHS Improvement and the MHRA sent a Patient Safety Alert through the central NHS system to further highlight sodium valproate’s risks during pregnancy.  

A public hearing was held in London on 26 September last year by the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee where EU citizens spoke of their experiences of the medication.

Mother-of-one, 28, wants to see sodium valproate banned after believing  it has caused her son, 3, to have severe autism and left him unable to speak

A mother-of-one wants to see sodium valproate banned after believing it has left her three-year-old son with severe autism and learning difficulties, as well as being unable to speak.

While pregnant, Natasha Mason, 28, claims she was warned by doctors she would risk her baby’s health if she stopped taking the medication.

Unaware of the risks and with scans coming back clear, Ms Mason, who is a full-time carer for her son and autistic fiancé John Salwood, 28, took sodium valproate twice a day for every stage of her pregnancy until her son Alfie Salwood was born nine weeks premature with breathing difficulties.

A paediatrician later diagnosed Alfie with sodium valproate syndrome as he had the classic facial features of small lips, a long forehead and no nose bridge.

Ms Mason, who is on antidepressants, blames herself for Alfie’s complications, adding his future is unclear as the youngster is still in nappies and is unable to feed himself.

Ms Mason says changing any routine is 'the end of the world' as Alfie throws tantrums

Ms Mason says changing any routine is ‘the end of the world’ as Alfie throws tantrums

She took sodium valproate every day of her pregnancy until Alfie was born nine weeks early

She took sodium valproate every day of her pregnancy until Alfie was born nine weeks early

WHAT IS FOETAL VALPROATE SYNDROME?

Foetal valproate syndrome occurs when babies are exposed to the drug during the first three months of their mothers’ pregnancies.

Symptoms can include autism, developmental delay, neural tube defects, heart abnormalities, limb problems and distinctive facial features, such as a long forehead, small lips and no nose bridge.

Treatment may involve paediatricians, surgeons and physiotherapists, depending on the individual sufferer’s symptoms. 

Source: National Organization for Rare Disorders 

‘If I change a routine it’s the end of the world’ 

After Alfie was born he was immediately rushed to intensive care, however, it was not until he failed to gain weight or hit his milestones that doctors properly recognised he was suffering.

Now a toddler, Alfie, who requires one-to-one support at nursery, throws tantrums and struggles to make friends.

Ms Mason said: ‘He doesn’t want to interact with people. If I change a routine it’s the end of the world.

‘He has meltdowns; he whacks the TV when adverts are on as he’s so frustrated.’

‘I blame myself’ 

Struggling to cope, Ms Mason finds it to difficult to stay upbeat.

She said: ‘It’s very hard. There are time when I feel quite low and depressed.

‘It has got on top of me. I blame myself.’ 

Fighting for justice, Ms Mason wants sodium valproate to no longer be available.

She said: ‘I want to see it taken off the shelf. I feel failed by the Government.’  

When he arrived, Alfie had breathing difficulties and was unable to control his temperature

When he arrived, Alfie had breathing difficulties and was unable to control his temperature

A pediatrician later admitted Alfie had sodium valproate syndrome, as he was born with the classic facial features of small lips, a long forehead and no nose bridge

A pediatrician later admitted Alfie had sodium valproate syndrome, as he was born with the classic facial features of small lips, a long forehead and no nose bridge

His condition was not taken seriously until he failed to gain weight or hit his milestones

His condition was not taken seriously until he failed to gain weight or hit his milestones

Now a toddler, Alfie (pictured with his parents) cannot talk or eat and still wears nappies

Now a toddler, Alfie (pictured with his parents) cannot talk or eat and still wears nappies

Mother-of-two, 35, is ‘furious’ as she believes sodium valproate has caused her daughter to suffer from learning difficulties, autism, delayed speech and incontinence

A mother-of-two is ‘furious’ as she believes sodium valproate has left her 15-year-old daughter with learning difficulties, autism, delayed speech and urinary incontinence.

Louise Duffy, 35, from Southampton, took sodium valproate every day of her first pregnancy after being reassured by doctors her baby was growing well.

Now a teenager, Ms Duffy’s daughter Kerry is unable to live the life of a normal adolescent as her mother panics her poor speech and autistic symptoms leave her vulnerable during evenings out.

Ms Duffy, a part-time retail assistant, said: ‘She wants to do what normal teenagers do but I have to tell her no. She thinks I’m a horrible mum.’

Despite Kerry, 15, suffering ill health as a baby, the teenager was only diagnosed with foetal valproate syndrome last year, resulting in her missing the vital support she needed as a child.

Now predicted under C’s in her GCSEs, Ms Duffy is forced to take medication to combat her stress as she struggles to come to terms with what Kerry’s future may be.

Kerry is unable to live the life of a normal teenager as her mother panics her delayed speech and autistic symptoms leave her vulnerable during evenings out with friends 

Kerry is unable to live the life of a normal teenager as her mother panics her delayed speech and autistic symptoms leave her vulnerable during evenings out with friends 

After being born three weeks early, she suffered breathing difficulties and a hole in her heart

After being born three weeks early, she suffered breathing difficulties and a hole in her heart

WOMEN LEFT IN THE DARK OVER SODIUM VALPROATE’S RISKS 

The risks of pregnant women taking sodium valproate were kept from patients for 40 years, a hearing was told. 

In September last year, campaigners presented evidence to a hearing of the European Medicines Agency in London, revealing that regulators knew of the problems as far back as 1973.

Even the drug’s manufacturer Sanofi was open about the risks.

Yet documents show UK officials decided at the time not to put the warnings on the packets for fear it ‘could give rise to fruitless anxiety’, the hearing was told.

It was not until 2015 that clear warnings were published.

Catherine Cox, from the Foetal Anti-Convulsant Support Association for the UK, said: ‘These warnings could have and should have been given in 1974.

‘A decision was taken not to publish them despite warnings by the manufacturer.’ 

Health professionals were told at the time: ‘This compound has been shown to be teratogenic in animals, meaning it could harm the human foetus.;

Yet the Committee on Safety of Medicines, which existed before the MHRA, said the warning should ‘not go on the package inserts, so that there would be no danger of patients themselves seeing it,’ according to documents seen by Sky News. 

Dr Eric Teo, who is in responsible for drug safety at Sanofi, told the hearing: ‘Sanofi had always provided the most up to date scientific information, with the approval of the health authorities.

‘There is a consent form for doctors to review with patients, there are patient cards to take home and there is also a prominent warning on the outside of the box.’ 

He also added that for some women valproate is the only option.

Dr Teo said: ‘Switching or discontinuing treatment before or during pregnancy carries the risk of recurrent seizures which could lead to brain damage or death.’ 

EPILEPSY DRUGS APPROVED IN THE US AND THEIR SIDE EFFECTS 

Sunovion’s Aptiom is linked to suicidal thoughts, liver problems and allergic reactions. 

Vimpat, manufactured by UCB, is associated with worsened depression and anxiety, as well as panic attacks and insomnia.

Eisai’s Fycompa can cause psychiatric problems, including believing things that are not true, seeing or hearing things that are not there, and extreme change in behvaiour.

Briviact, also manufactured by UCB, is known to cause dizziness, nausea and vomiting, as well as co-ordination problems. 

‘It’s affected her whole future’ 

During her first pregnancy, Ms Duffy was warned sodium valproate could cause her baby to suffer from spina bifida or Down’s syndrome, however, she felt reassured when all her scans came back clear.

After Kerry was born three-and-a-half weeks early, the warning signs appeared almost immediately when she was rushed into intensive care with breathing difficulties and a hole in her heart. 

Kerry did not crawl until she was one-year-old, with the average being seven to 10 months, and only stood at two, while most babies stand between nine and 12 months old.

After years of back-and-forth with doctors, she was finally diagnosed last year.

Ms Duffy said: ‘It’s affected her whole future. It makes me so angry and frustrated.

‘She wants to do what normal teenagers do but I have to tell her no. She can’t go to town on her own, she’s too vulnerable. She thinks I’m being a horrible mum.’

‘I have to take drugs to reduce my stress’  

Ms Duffy said: ‘Kerry will never be able to live alone; she can’t get by.’

As well as affecting Kerry, Ms Duffy’s mental health has also been battered by her daughter’s condition.

She said: ‘I have to take drugs to reduce my stress. I get stressed out thinking about her future.’

Ms Duffy claims Kerry's symptoms were not taken seriously until she did not hit her milestones

Ms Duffy claims Kerry’s symptoms were not taken seriously until she did not hit her milestones

Despite her ill health as a baby, Kerry was only properly diagnosed last year 

Despite her ill health as a baby, Kerry was only properly diagnosed last year 

What the manufacturer says

Michael Szumera, head of communications at Sanofi, told MailOnline: ‘Valproate has at all times been supplied by Sanofi in the UK with a warning of the risk of malformations in babies born to mothers with epilepsy who take the product during pregnancy. 

‘The product information for valproate (including the addition of warnings on the package labelling) has at all times been approved by the regulatory authorities as properly reflecting current scientific and medical knowledge before being put into circulation.

‘In the UK, product information for Sanofi’s valproate products has been updated regularly based on current scientific knowledge and as approved by the regulatory authorities. 

‘As scientific knowledge about the risks associated with the use of valproate has increased, particularly during pregnancy, Sanofi has demonstrated full transparency to health authorities and initiated the updating of medical information for doctors and patients. 

‘Sanofi has systematically reminded patients via the information document that they should consult their prescribing physician in case of pregnancy or desire for pregnancy so that their physician can act accordingly.’  



Read more at DailyMail.co.uk