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Sodium Valproate

Sodium Valproate is an effective anti-epileptic drug which causes physical malformations, autism and developmental delay in many children when it is taken by their mothers during pregnancy. It is commonly known by brand names including Epilim, Episenta and Depakote. They are licensed in the UK to treat epilepsy and bipolar disorder. These medications are also used for migraine prophylaxis, and pain management. Approximately 27,000 women of childbearing age take valproate in the UK.

The Problem

Evidence has emerged that it can cause physical and neurodevelopmental effects in children if taken by mothers during pregnancy. This group of features is currently termed as
‘Foetal Valproate Spectrum Disorder’ (FVSD). FVSD will be added to the next WHO International Classification of Diseases, ICD-11 following campaigning by patients.

In 2004, National Institute for Health and Care Excellence (NICE) guidance clearly stated it was the responsibility of the clinician to give accurate information and counselling. This should be tailored to individual need, to enable girls and women to make informed decisions. In many cases doctors dismissed their concerns before their pregnancies. This prevented them from making an informed choice. Indeed afterwards, when their child was affected by FVSD, it impacted their ability to access support or make decisions about subsequent pregnancies.

The Toolkit

The Toolkit

  • The valproate ‘Toolkit’ set up in 2016, which provided information for patients and healthcare professionals, and the Pregnancy Prevention Programme (PPP) in 2018. Currently all girls and women of childbearing potential should only be treated with valproate if the conditions of the PPP are met:
  • Women should have received counselling about the risks of valproate treatment and the need for effective contraception and have signed a Risk Acknowledgement Form
  • Highly effective contraception should be used
  • They are reviewed by their specialist at least annually sodium valproate

Valproate may still be prescribed in pregnancy to women with epilepsy who are resistant or intolerant to other treatments. This use is unlicensed, even when treatment is based on an informed choice made by the patient. In these situations, the woman and her specialist must still sign the Acknowledgement of Risk Form to confirm that options for switching treatment have been discussed, and the woman is fully aware of the risks of pregnancy whilst on valproate, and has had the opportunity for counselling about the risks.

Where it Goes Wrong

In some cases families did not receive information about the risks of treatment with sodium valproate during pregnancy. This prevented women from making informed choices about their treatment and family planning options and caused life-long impact. Women are still becoming pregnant whilst on valproate without any knowledge of the risks. This means that babies are being born having been exposed to the drug.

Some women experience miscarriage and still births. Many children develop new symptoms as they get older. There is a huge problem gaining support and access to services. The impact of a family having one parent with epilepsy, and one or more children with physical and/or neurodevelopmental problems from valproate exposure has been described as a ‘double disability.

What is Foetal Valproate Spectrum Disorder?

Affected children have a higher chance of having birth defects such as cleft palate, spina bifida, heart problems, and limb defects. They may have minor physical differences such as differences in their facial features which give rise to a recognisable pattern, or bendy joints. Children with FVSD have an increased risk of language difficulties, intellectual disability, memory problems, learning and behaviour problems. In some cases, they are diagnosed with Autism Spectrum Disorder or Attention Deficit Hyperactivity Disorder.

Compensation

The Review by Baroness Cumberlege in July 2020 recommended that an ex gratia scheme to provide discretionary payments should be established (Chapter 1, Recommendation 4). These payments are to supplement current health and social care provisions. Eligibility should be based on avoidable harm occurring after in utero exposure to valproate. They do not and cannot make recommendations on compensation, which remains the preserve of the courts. Steps can be taken to make lives easier. This scheme should provide practical needs based help with the additional costs that FVSD incurs. It remains to be seen if such a fund will be set up.

If you have a claim arising from pregnancy after 2014 then get in touch with us today by contacting Dr Victoria Handley vhandley@handleylaw.co.uk or calling free on 0800 470 2009

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