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Sodium valproate – hoping for support and answers for families affected by Foetal Valproate Syndrome

On the day that Baroness Cumberlege's review into the current regulatory regime for medical drugs and devices was due to be published, Bozena Michalowska-Howells discusses what families affected by sodium valproate are hoping to see in the review.

Posted on 24 March 2020

This week the Independent Medicines and Medical Devices Safety (IMMDS) Review was due to be published addressing concerns raised by patients and families about three medical interventions: the hormone pregnancy test Primodos, the anti-epileptic drug sodium valproate, and surgical mesh. The review has quite rightly been postponed given the ongoing coronavirus pandemic. However, those affected are hopeful that when the review is published it will include robust recommendations to support those affected and ensure similar harm does not happen again.
Myself and my team are currently supporting around 70 families affected by the use of sodium valproate during pregnancy, which caused physical and mental health problems in their children known as Foetal Valproate Syndrome (FVS), which is now called fetal valproate spectrum disorder, due to its acknowledged complexity. In some case this led to the death of their child or children.
Sodium Valproate is a highly effective anti-convulsant drug, prescribed to control epileptic convulsions. Marketed by pharmaceutical giant Sanofi and better known as Epilim, the drug was first licensed for use in the UK in 1973.
The product safety team at Leigh Day worked with families affected by sodium valproate to produce a 300-page submission to the IMMDS review. The submission requested a number of outcomes including a compensation and care package for all those families affected by FVS through a collective redress scheme; a public inquiry into access to justice for victims of pharma harm and how consumer protection law in the UK can better safeguard consumers; a disability pathway of care and services that provides accessible and coordinated medical care and therapies through specialist regional centres; and a requirement that the pharma industry contribute to the cost of services and financial support.
The families that I have been working with have been fighting for decades to raise awareness of the dangers of sodium valproate for pregnant women and to get answers as to why it continued to be prescribed with little warnings.
They believe there was an ‘Information Gap’ between what patients were told about the harmful effects of the drug between 1973 and 2005, and what research, regulators and Sanofi allegedly knew but chose not to include on Patient Information Leaflets. This includes the failure to include on the packaging for Epilim the increased risk of Foetal Valproate Syndrome and the need for pre-pregnancy counselling for those taking the drug.
I have heard from them the immense challenges they have faced caring for children with complex health needs, while also managing their own epilepsy. Many of them feel they have been abandoned by the Government, having been provided with no compensation for the harm that their children suffered due to a drug prescribed by the NHS.
Some of those suffering from FVS require round-the-clock care. Many case studies were included in the submission made  which can be found on the IMMDS website.
They include the case study of Deborah Mann who was prescribed Epilim at the age of 16. She was prescribed 3000mg a day aged 18 and after becoming pregnant her Eplilim dosage was increased from 4500mg per day to 5000mg per day. She gave birth to four children, two of which did not survive following birth. Her two surviving children both have been diagnosed with FVS and will require full time care for the rest of their lives. Her eldest surviving child has had to undergo 13 operations on her ears and also suffers from, autism, arthritis, and asthma among other conditions. Her second child Branwen also suffers from Arthritis, Hypotonia and severe Astigmatism and migraines as well as other conditions typical of FVS.
Branwen explained as part of the IMMDS submission “There are days when I do not want to leave the house because of the pain I am in (migraine, joints etc) I have been told that I could go blind, have a stroke or die at any time.  I have depression and anxiety disorder all make worse due to me being an unacknowledged full-time carer, for my mother whose epilepsy is not properly controlled, etc etc.  I am unable to lead a normal life, I push on and do things the best I can.” 
It is estimated that around 20,000 individuals are affected by FVS in the UK and that FVS was and is, in most cases, an injury that could have been avoided.
As well as supporting families in relation to the IMMDS review Leigh Day is also investigating clinical negligence claims for those whose children suffered FVS after being prescribed sodium valproate after 2005, when the risks were better known among the medical community. We look forward to the publication of the review when it is safe to do so.


Boz Michalowska
Medical devices Product safety Consumer law Financial claims Emissions claims

Bozena Michalowska Howells

Bozena joined Leigh Day in 1997, was made a partner in 2003 and is head of the firm's product safety and consumer law team.