Sodium Valproate and Foetal Valproate Syndrome

A Scandal 40 Years in the Making: Sodium Valproate and Foetal Valproate Syndrome

We have written much about the negative impacts of Sodium Valproate, and as a result, we have seen an increase in those affected coming forward to seek justice and file pregnancy injury compensation claims. In this article, we take a more in-depth look at this scandal to understand the risks of taking Sodium Valproate, the signs and symptoms of Foetal Valproate Syndrome (also known as Foetal Anticonvulsant Syndrome), and the latest developments in the campaign to bring more awareness and provide greater support for those affected.

If you have been affected, contact a solicitor to establish your right to make a Sodium Valproate claim, and pregnancy injury compensation, immediately. Our personal injury team, led by our Sodium Valproate specialist Solicitor, Simon Pimlott, has the expertise and knowledge to advise and represent you if you wish to make a claim for personal injury following taking Sodium Valproate.

To talk about how we might be able to help, please phone our Sodium Valproate solicitors on 0333 123 9099, email us at enquiries@ibbclaims.co.uk or fill in our contact form. Any discussions you have with us will be in the strictest of confidence and handled with the utmost sensitivity.

What is Sodium Valproate?

Sodium Valproate (also referred to as valproate or valproic acid), sold under the brands Convulex, Depakote, Encorate, Epilim, Episenta, Epival, Stravzor, Valex, Valpro, is a medication prescribed to treat epilepsy and seizures.

What is Sodium Valproate used for?

Sodium Valproate can treat epilepsy and seizures by reducing the amount of abnormal electrical activity in the brain[1]

However, these drugs have long been known to risk serious side effects if taken by pregnant women, including an 11% chance of a birth defect, and a 40% risk of developmental problems in children of mothers prescribed the medication. The proper diagnosis for this condition is ‘Foetal Valproate Syndrome’[2] (sometimes also known as Sodium Valproate Syndrome) and can allow a Sodium Valproate claim to arise.

What are the concerns arising from the use of Sodium Valproate?

Sodium Valproate has been used successfully over many years to treat patients with epilepsy and bipolar disorder. However, there is evidence to indicate that taking Sodium Valproate while pregnant may cause birth defects. Furthermore, it is suggested that those birth defects can be passed on to the next generation. 

The use of Sodium Valproate has been linked to 20,000 cases of catastrophic disabilities in children in the UK. Norman Lamb, MP, has referred to the situation as an “extraordinary scandal”.

According to the Epilepsy Society, seven women in 100 (7%) who are prescribed Sodium Valproate had a baby born with a major malformation. This figure would rise to 1 in 10 women (10%) if they took more than 1000 mg per day. Furthermore, up to 40% of mothers who took this medication have children who have difficulties with development and learning.

What are the brand names of Valproate medicines?

  • Absenor
  • Convival
  • Chrono
  • Convulex
  • Convulsofin
  • Tabletten
  • Delepsine
  • Deprakine
  • Diplexil
  • Dipromal
  • Epilim
  • Episenta
  • Epival
  • Ergenyl
  • Espa-Valept
  • Hexaquin
  • Leptilan
  • Micropakine LP
  • Orfiril
  • Orlept
  • Petilin
  • Valberg
  • Valepil
  • Valhel

What is the latest advice about taking Sodium Valproate?

On 24 April 2018, the Medicines and Healthcare Products Regulatory Agency (MHRA) issued a statement stating, “Valproate must no longer be prescribed to women or girls of childbearing potential unless they are on the pregnancy prevention programme (PPP)”. Additionally, the MHRA recommended women currently taking the medication should seek a review with their doctor.

The National Institute for Health and Care Excellence (NICE) states, “Medicines containing valproate taken in pregnancy can cause malformations in 11% of babies and developmental disorders in 30-40% of children after birth. Valproate treatment must not be used in girls and women, including in young girls below the age of puberty, unless alternative treatments are not suitable and unless the terms of the pregnancy prevention programme are met. In pregnancy, valproate is contraindicated, and an alternative treatment should be decided on, with appropriate specialist consultation”.

What is Foetal Valproate Syndrome?

Foetal Valproate Syndrome (FVS) or Foetal Anticonvulsant Syndrome (FACS) (sometimes also referred to as Sodium Valproate Syndrome), can occur if a baby in-utero is exposed to the valproic acid, a key constituent of Sodium Valproate, and can cause minor to severe birth defects and development problems (see below). There is no cure for FVS. However, there is a wide range of effective therapies and interventions which can improve the long-term prognosis of people with the syndrome.

Signs and symptoms

After giving birth, it may not be immediately apparent a baby has suffered the effects of Sodium Valproate during pregnancy; indeed, many children born to mothers who had taken the drug during pregnancy are born with no problems at all. The signs to look for are as follows:

  • Facial features – those diagnosed with FACS may present with characteristic features, including epicanthic folds (skin of the upper eyelid covering the corner of the eye and a small, upturned nose with a wide bridge).
  • Congenital heart problems
  • Spina-bifida – a defect whereby the spinal cord does not develop properly and is exposed through a gap in the vertebrae. This can lead to weakness, paralysis, problems with bladder control, and orthopaedic abnormalities such as scoliosis of the spine
  • Cleft-lip/palate
  • Genital abnormalities
  • Skeletal abnormalities – these may include clubfoot, rib cage abnormalities, or stiff joints
  • Development delay – which may be characterised by autism, learning disabilities, impaired memory, delay in developing gross motor skills, communication problems, and/or ADHD. 

If you were prescribed Sodium Valproate during pregnancy and have observed any of these signs or symptoms in your child, it is imperative you speak to your GP. If your GP has concerns your child may have FVS, they will ensure they have access to the necessary specialists who can seek to manage each condition as much as possible. 

It is important to understand there is no single test that can point to a diagnosis of FACS; rather, this will be suspected if a presenting child has one or more of the signs above, and the mother has a history of taking Sodium Valproate during pregnancy.

A study in 2000 of 57 children with FVS in the Journal of Medical Genetics showed 81% had behavioural problems (half of which displayed hyperactivity and poor concentration), 60% showed characteristics of autism, 77% had learning disabilities, 81% had a speech delay, 60% had a gross motor delay, 42% had a fine motor delay, and 70% had overly loose joints[3]. This study suggests that some children with FACS present with more than one symptom, which may include a mix of physical and behavioural problems.

Treatment for Foetal Valproate Syndrome

For children with FVS, the treatment provided will address each of the presenting symptoms independently. In practice, this means individual children will be managed differently, depending on the precise nature and extent of each problem, by a range of different specialists.

Surgical intervention can be employed where necessary to repair defects such as those related to spina bifida, cleft lip/palate, and heart problems. Speech and language therapy will be offered for children experiencing communication problems because of FVS. Physical impairments may require the expertise of an occupational therapist or physiotherapist, and behavioural matters may be addressed by educational specialists and psychologists. 

Coping with the guilt of Foetal Valproate Syndrome

Some children with more acute symptoms of FVS may require life-long care. In the case of 19-year-old Bridget Buck, whose mother Karen was interviewed by BBC News in January 2018, doctors believed Bridget might only have months to live due to the deterioration in her health. 

Bridget was born with brain damage and spina bifida after her mother was prescribed Sodium Valproate.  Ms Buck told the BBC, “I do all Bridget's overall care. I think for Bridget, I talk for Bridget, I walk for Bridget. I live for Bridget….Mothers shouldn't have to bury their daughter; no mother should do that"[4].

Julie Marjot from Wymondham also knows at first hand the damaging effect of Sodium Valproate. All four of her children had health complications after she was prescribed the anti-consultant drug during pregnancy. 

Speaking to local media in Norfolk, she explained that after seeking specialist advice, she was warned the drug could lead to a cleft palate or Down’s Syndrome, but she was not told of the other dangers. On the balance of the risks presented, Ms Marjot and her husband decided to have children. 

Her 21-year old daughter now has epilepsy, dyslexia, and a cataract, she has a son with autism, a hole in his heart, and impaired hearing, and she has another daughter with a cleft palate and a hole in her heart, thumbs not in the correct place, and hearing problems. 

“I have to live with the stress and guilt,” Mrs Marjot said. “Even though people say it was not your fault, it doesn’t matter. I’m going to take that to the grave with me”[5].

The hidden danger of Sodium Valproate

One of the most concerning aspects of the Sodium Valproate scandal is how long it has persisted. According to a hearing of the European Medicines Agency in London in September 2017, regulators have known for 45 years (since 1973) that the anticonvulsant drug could cause serious birth defects.

At the hearing, Joanne Cozens, chairwoman of the Organisation for Anti-Convulsant Syndromes, was scathing of manufacturer Sanofi, and the drug regulators, stating during the hearing, “Sanofi have a loyal bunch of clinical experts promoting valproate and resisting warnings…..I can see a few in the room today. You know who you are, and we don't trust you anymore because you are complicit in avoidable injury to children”. 

At the same hearing, Karen Keely from the Foetal Anti-Convulsant Syndrome Forum in Ireland, whose three sons all have birth defects after she was prescribed Epilim stated, “Two of my three boys require life-long care and will never live a normal life, will never be able to have children or get married”[6].

Will there be inter-generational legacy of Foetal Valproate Syndrome?

Those who have experienced FACS at first hand are concerned there may be an intergenerational impact related to Sodium Valproate. One such individual is Sue Jenkinson from Liverpool, who told the BBC that not only did her two daughters develop FACS after she took the drug during while pregnant, they have also gone on to have their own children who are showing signs of the syndrome, despite the fact Sodium Valproate was not taken by either woman during pregnancy. 

One of Ms Jenkinson’s grandsons has been diagnosed with dyspraxia (a developmental disorder characterised by impaired coordination and movement), learning disabilities, and a bowel condition[7]. According to Lord O’Shaughnessy, Parliamentary Under-Secretary of State, Department of Health and Social Care, an expert working group of the Commission on Human Medicines has now been tasked with considering the evidence of the intergenerational effects of Sodium Valproate[8].

It has not yet been formally established that taking Sodium Valproate causes downstream damage within families; however, such concerns will only heighten the worry and guilt felt by mothers who took the drug on the recommendation of their GP. If the risk is passed down to grandchildren, great-grandchildren and beyond, the costs, emotionally, physically, and financially could be incalculable, especially given the drug has been used by pregnant women internationally, without sufficient warning, since the 1970s.          

Campaigning for justice and support

Norman Lamb, the Liberal Democrat MP for North Norfolk, is spearheading a campaign to increase awareness and seek action regarding the Sodium Valproate scandal. Such is Mr Lamb’s concern over the scale of this health scandal; he is seeking affirmative action, including:

  • An inquiry along the lines of that undertaken in the wake of the Hillsborough disaster (see a review of patient safety below)
  • Financial recompense for victims – he referenced funds made available in France for this purpose, and;
  • A mandatory warning to pregnant women prescribed Sodium Valproate – this was put in place in April 2018 when the government implemented a ban on valproate for women who are not on the pregnancy prevention programme (PPP), smaller pack sizes to encourage monthly prescribing, and new warnings on the medication to make the dangers of taking the drug clear.

Review of patient safety

In February 2018, the government announced an Independent Medicines and Medical Devices Safety Review following three high-profile health scandals - namely, the hormone pregnancy test Primodos, Sodium Valproate, and the use of vaginal mesh, to be led by Baroness Julia Cumberlege. Baroness Cumberlege is being asked to review the following key questions:

  • Whether any further action is needed relating to the complaints around Primodos, Sodium Valproate and vaginal mesh
  • The processes followed by the NHS and its regulators when patients report a problem
  • How to make sure communication between the different groups involved is improved

Baroness Cumberlege stated, “I look forward to undertaking this tremendously important review and in particular to working with patients to ensure that our health system learns from those it may have failed. It’s essential that voices aren’t just listened to, but properly heard, and that whenever appropriate, the system promptly learns lessons and makes changes”[9].

While the Review was ongoing, an early recommendation by Baroness Cumberlege relating to the surgical mesh scandal (that its use should be paused and not resumed until several strict criteria have been met), has been implemented by the government[10]

The Review published its report on 8 July 2020 and closed on 31 July 2020. It set out actions and a number of recommendations it believed needed to be taken to minimise the harm of Sodium Valproate and support those already affected, including:

  • Continuing to improve communication of the risks
  • Identifying those affected by Sodium Valproate exposure in utero and helping them access support
  • Establishing specialist centres for those affected by teratogenic medication
  • Creating an ex gratia scheme to provide needs-based payments to those affected
  • Collecting data on women on all antiepileptic drugs and their children
  • Reducing and monitoring the effects of other medications taken during pregnancy[11]

The government has not accepted all recommendations but will take a number of actions in relation to Sodium Valproate.

The government’s full response to the Independent Medicines and Medical Devices Safety Review recommended actions for improvement can be found here.

Among the actions taken, the government has directed the recently established Valproate Safety Implementation Group (VSIG) to lead the work on reducing the prescribing of Valproate and better supporting women to make informed healthcare decisions.

The government is also strengthening the regulation of Sodium Valproate. In 2018, the Medicines and Healthcare products Regulatory Agency (MHRA) and NHS Digital started to set up the Valproate Registry to support regulation, and the first report was released in February 2021[13]. The Registry will also be expanded to cover other antiepileptic drugs.

Bringing a claim for compensation

Sodium Valproate has caused untold damage worldwide. The guilt and anguish of mothers told their child has a serious disability or health condition because of a drug they took in pregnancy, and the pain and suffering of those who have been diagnosed with FVS is something no one should ever have to suffer. For those diagnosed with FVS, the only path is to continue to seek the very best medical treatment and to ensure everything possible is put in place to provide the best quality of life possible for their child.

I took Sodium Valproate many years ago. Is it still possible to bring a claim for compensation?

There are time limits for bringing pregnancy injury compensation claims, but where knowledge as to the cause of the birth defect has only recently become known, it may still be possible to bring a claim for compensation after 20 or 30 years, or perhaps longer, bearing in mind important information about the possible side effects was kept hidden from mothers to be, from the time the product was being licensed.

There have also been calls for the government to set up a compensation fund (as has been done in France), although as of the summer of 2018, the government have not responded to such a request.

Contact our Sodium Valproate claims solicitors today

However, extensive medical treatment and care come with a cost, which is why it is imperative you seek compensation as soon as possible. There are time limitations related to bringing a claim for pregnancy injury compensation – typically, you will need to do so within three years of the damage being caused, or the date you were aware of the link between taking Sodium Valproate and problems incurred by your child/ren.

If you were prescribed a Sodium Valproate drug during pregnancy and are concerned about possible harm to your unborn child, or if you have a child with any of the signs or symptoms outlined in this article, your first action should be to visit your GP.  If at any point you need legal guidance on this matter or wish to seek financial compensation, talk to a solicitor specialising in medical negligence cases with a background in dealing with high-profile scandals of this nature.

At IBB, our personal injury team has the expertise and knowledge to advise and represent you if you wish to seek compensation for serious medical negligence abuse. To talk about how our Sodium Valproate solicitors might be able to help, please phone us on 0333 123 9099, email us at enquiries@ibbclaims.co.uk or fill in our contact form. Any discussions you have with us will be in the strictest of confidence.

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