Sodium Valproate: The Fetal Valproate Syndrome Tragedy

Written by Sharon Hartles

In this article, Sharon Hartles reflects upon the significant impacts of avoidable harms that have been perpetuated for decades as a result of medical negligence on behalf of the regulator (Committee on Safety of Medicines) that advised the UK Licensing Authority on the safety of medicines and the manufacturer of Epilim (Sanofi). Sharon Hartles is a member of the Open University’s Harm and Evidence Research Collaborative.

Sodium Valproate

Sodium valproate, marketed as Epilim in the UK, has been linked to physical, developmental and neurological harms in the human fetus.


In the UK, Epilim is the dominant sodium valproate medication used to treat patients at risk of epilepsy associated convulsions. Epilim is an effective anti-convulsant medicine (epilepsy drug) and for this reason it has been licensed for usage since 1973. However, Epilim is also a teratogen; thus exposure to this drug causes an increased risk of physical, developmental and neurological harms in the human embryo or fetus.

Given the fact that sodium valproate is harmful, wherever possible it clearly should not be prescribed to female patients of childbearing age.  Despite this, the regulators and Sanofi, the company responsible for manufacturing and marketing Epilim (Sanofi acquired the company from Reckitt-Labaz in or around 1980) chose to keep patients in the dark for decades and did not disclose the known associations. As a consequence, patients were unable to make informed choices, which has resulted in the preventable fetal valproate syndrome tragedy.

According to The independent Medicines and Medical Devices Safety Review, congenital birth defects associated with in utero exposure to sodium valproate include:

  • Neural tube defects (NTDs), such as spina bifida 
  • Cleft lip and palate
  • Facial and skull malformations
  • Heart, kidney, urinary tract and sexual organ malformations
  • Limb defects
  • Developmental delay
  • Autism Spectrum Disorders (ASDs)
  • Attention Deficit Hyperactivity Disorder
  • Ear malformations and auditory processing
  • Skeletal malformation
  • Arthritis in older children
  • Effects on the endocrine system
  • Sexual identity problems (which occur due to a mismatch between genital development and neural / sexual identity development).
  • Psychomotor issues.
  • Withdrawal symptoms – associated with prenatal sodium valproate exposure.

Fetal valproate syndrome harms are widely accepted within the clinical and regulatory community, including by: the National Institute for Health and Clinical Excellence (NICE), the Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA).

During the 1960s and 1970s, articles were published drawing attention to the concerns about the teratogenicity and anti-epileptic (anti-convulsant) medication this included research by: Lawrence, 1963Janz and Fuchs 1964Meadow 1968Speidel and Meadow 1972,  Lowe, 1973Fedrick 1973Hill 1974Barr, 1974 and Hanson and Smith 1975. Yet, despite the known harms, documents uncovered from The National Archives revealed that in 1973, the Committee on Safety of Medicines (a precursor to the  Medicines & Healthcare products Regulatory Agency) thought it best not to make patients aware of the dangers because “it could give rise to fruitless anxiety”. 

The controversy surrounding the abhorrent failure to communicate the preventable risks to clinicians and patients was evidenced again because by the early 1980s the regulator and manufacturer was in possession of sufficient information to conclude that Epilim increased the risk of congenital abnormalities. Even though the links between the exposure to sodium valproate and the increased risk of harms to a fetus were well-documented, patients were not informed directly of the link until 2005. In some cases care pathways for women of child-bearing age were not established until 2016. In February 2018, the European Medicines Agency put in measures to avoid valproate exposure in pregnancy.

A visual warning of the pregnancy risks (in the form of text) with other warning symbol on the outer carton

A visual warning of the pregnancy risks (in the form of text) with other warning symbol on the outer carton.

The fetal valproate syndrome tragedy (medical negligence) was entirely avoidable, resulting from a regulation failure and decades of inaction by successive governments to safeguard patients. The true number of individuals’ harmed by sodium valproate in utero since it was licensed in 1973 in the UK is unknown, however, the consensus estimate is around 20,000.  More recent evidence suggests that the medical problems associated with fetal valproate syndrome may be passed down the generations.

The role that the regulator and the manufacturer Sanofi have played in creating and perpetuating this tragedy is evident, therefore financial redress should be paid to all those affected by fetal valproate syndrome.

Currently, 27,000 women of child bearing age are taking valproate in the UK. On 2nd March 2021, in the House of Lords, James O’Shaughnessy, Vice-chair for the All-Party Parliamentary Group for First Do No Harm, reported that since June 2020, 150 babies had been born suffering harms due to sodium valproate exposure. Therefore it is imperative that the Government find ways to minimise the risk of harms to future babies. Beyond this, lessons must be learned and mechanisms put into place to ensure avoidable systemic failures on this scale do not happen again. 

Letter released to women and girls taking Sodium Valproate


NHS Issues Advice To Girls And Women Taking Sodium Valproate For Epilepsy

20,000 women and girls will this week be reminded of risks during pregnancy while taking an epilepsy drug, as part of the NHS’s drive to increase patient safety.

Over the coming days letters are being sent to females in England aged between 12 and 55 who are currently recorded as having an active prescription for the drug, Sodium Valproate, outlining a number of actions to take if they are pregnant, trying for a baby or have not had a recent medication review.

Sodium valproate is a drug that can be used to treat epilepsy and bipolar disorder, however babies can be harmed if the person taking the drug becomes pregnant.

The NHS is now sending reminder letters as part of the organisation’s drive to inform patients and prevent future risks.

The letter from the NHS Director of Patient Safety, Dr Aidan Fowler, will urge those with an active prescription to continue their treatment course until their doctor tells them otherwise, but to:

  • Continue to take contraceptive measures, ideally the implant or coil, while they are taking valproate;
  • Speak to their GP immediately if they think they may be pregnant;
  • Seek a medicines review from their GP if they haven’t received one in the last 12 months, and;
  • Speak to their doctor if they are keen to try for a baby, before coming off contraception.

The reminder is part of the NHS’ ongoing response to former health Minister Baroness Cumberlege’s Independent Medicines and Medical Devices Safety Review, published last year.

A new data registry has also been established, managed by NHS Digital, to better track prescriptions to women.

NHS Patient Safety Director, Dr Aidan Fowler, said:

“Valproate is the best treatment available for a small group of people with very complex illnesses, so it’s vital those who have an active prescription for it to continue taking it until they are told otherwise by their GP or consultant.

“It’s vital too however that everyone understands the risk that doing so poses to your unborn child if you are pregnant, and this letter is a reminder of information that every woman and girl of childbearing age should receive from their doctors when the drug is first prescribed”.

Sodium valproate was approved for use in 1974 and has always carried warnings for doctors about the possible risks if it is taken while pregnant. These have been strengthened over the decades as more data has become available about higher rates of physical birth defects, autism and child developmental problems.

Due to this risk, in 2018 the heads of all medicines agencies in the UK issued a joint edict saying that all women and girls who could potentially conceive should be provided with and urged to use contraception for as long as they are taking valproate, even if they are not sexually active.

Doctors are expected to discuss the risks with patients as part of the shared decision around prescribing valproate, and put in place a pregnancy prevention plan to eliminate risk if it is prescribed, or use other forms of treatment if the patient wishes to have a baby.

Emma Murphy – Managing Director of INFACT

“We welcome this letter of communication being sent to all females of childbearing age informing them of the risks of Valproate in Pregnancy. This is something that should have been done from the very beginning and it has been a long and arduous campaign by INFACT to reach this goal. We are not only glad for ourselves that now Governing Bodies are taking these steps but most importantly for the patients prescribed the drug and the potential damage to the lives of unborn children”

March in Review

The start of the month saw INFACTs new Website Facebook / Twitter and Just Giving Page all go live with our following steadily growing. We also started working with Anna Christian Campaigns whose help and advice has been invaluable and we are so happy to have her backing as we move forward.

As the Remit deadline approached mid March, the parents submissions being sent to us increased in number and were all included along with submissions sent to Norman Lamb MP, INFACTs medical team reports, and INFACTs own extensive files and were all passed to Michael Mansfield’s team at Nexus Chambers for them to start finalising and drafting his report which is due back early April.

We also finished sending out registration emails and numbers to everyone on our database which now stands at 1200+ . We had quite a lot of issues with people registering with one email but then using a different one for their day to day business and also Facebook user names being different to registered names on the database.
If anyone still has worries about their registration number please do get in touch at

We travelled down to Parliament twice, welcoming new MPs onto the APPG. We also held an extremely well attended APPG meeting in which the direction of the group was agreed.

INFACT welcomed the announcement and recommendations from European Medicines Agency  and MHRA that no woman of child bearing age is to be prescribed Valproate unless she is on the newly introduced Pregnancy Prevention Plan which means:

Valproate medicines are now therefore contraindicated, i.e. must not be used, in girls and women able to have children unless the terms of a special pregnancy prevention programme are followed. These include:

  • an assessment of each patient’s potential for becoming pregnant,
  • pregnancy tests before starting and during treatment as needed,
  • counselling about the risks of valproate treatment and the need for effective contraception throughout treatment,
  • a review of ongoing treatment by a specialist at least annually,
  • introduction of a new risk acknowledgement form that patients and prescribers will go through at each such annual review to confirm that appropriate advice has been given and understood.

We attended 2 high level meetings, in one of which we were invited onto the Expert Working Group at MHRA which was a very proud moment for INFACT. Whilst we cant divulge the discussions of these meetings due to the content and confidential nature we can say the direction in which the Valproate issue is now travelling is extremely positive. We will update on this as and when we can.


This month understandably has also seen us receive increasing enquiries about the Cumberlege Review. We can confirm that NO “Terms of Reference” have yet been set, which basically means nothing has been asked for in respect of that Review and a start date has not been given either.
Whilst the Michael Mansfield QC report will eventually filter into the Cumberlege Review, the reason INFACT have legal representation for our remit is an entirely separate matter from the Cumberlege Review. It is now more important than ever that you or anyone you know who may have been harmed by Sodium Valproate are registered on our Database

With dates in the diary already, April is set to be another busy month for INFACT and all donations to the Just Giving Pageto help with the ongoing fight for our children’s future which is now closer than ever, no matter how small are all greatly received.

We thank all our team who are working extensively and productively.




Campaign Update

After returning from Parliament yesterday INFACT can confirm that all submissions received through the APPG have now been passed to Michael Mansfield’s team at Nexus Chambers.

The APPG for Valproate and other AEDs in Pregnancy will continue to focus on its Campaign in Parliament whilst INFACT now move forward with the backing of the APPG and Michael Mansfield QC.

INFACT have now instructed for all documentation and submissions in relation to the Sodium Valproate Campaign be reviewed and drafted by Michael Mansfield QC.

History of APPG for Valproate and other AEDs in Pregnancy

A brief insight into the history of the APPG

In 2013 INFACT were invited by the then Chair Alec Shellbrooke MP to join the already long established APPG for Thalidomide which was subsequently renamed the APPG for Thalidomide and other harmful drugs. Prior to this there was no representation for Valproate in any APPG.

In 2015 we had gained enough support in Parliament to establish our own APPG which was named APPG for AEDs in Pregnancy with our chair being Theresa Pearce MP.

In 2016 Theresa Pearce stepped down as chair. We had worked closely with Norman Lamb MP since 2014 through his position as Minister for care and support in the then coalition government and were delighted when he agreed to our invitation to become chair, changing the name once more to Valproate and Other AEDs in Pregnancy. - INFACT - FACSA