Sodium Valproate and the Risk of Birth Defects: Why Weren’t Women Warned?

On 22 February 2018 the Health and Social Care Secretary at the time, Jeremy Hunt, launched a  review into the NHS response to patient concerns relating to side effects from treatments. 

The review examined three specific NHS treatments:

  • The hormone pregnancy test Primodos, (used up until 1978): The use of Primodos was alleged to have resulted in birth defects and miscarriages however the manufacturer, Schering, now part of Bayer, denied a link between the drug and deformities in babies. In 2017, a government review said there was not enough evidence to prove a link. However this has since been contested by scientists at Oxford University.
  • The anti-epileptic drug Sodium valproate: Sodium valproate is used to prevent seizures in epileptics. However if taken during pregnancy it can cause physical abnormalities or defects, developmental problems and autism to the baby.
  • The use of transvaginal mesh: The vaginal or pelvic mesh was used to treat prolapse and incontinence in women, however many women have reported severe pain and infection.

Jeremy Hunt commented:

“Over the years, there have been significant concerns raised by individuals and campaign groups about the potentially harmful effects of 3 products used by the NHS. The response they have received from those in positions of authority has not always been good enough.

From Primodos to mesh and sodium valproate, patients and their families have had to spend too much time and energy campaigning for answers in a way that has added insult to injury for many. I want to see if we can establish a fairer and quicker way of resolving these concerns both now and in the future”.

Baroness Julia Cumberlege, the head of the review, was to consider:

  • Whether further action was required on patient concerns relating to Primodos, Sodium valproate and vaginal mesh
  • Whether the NHS process of dealing with complaints was adequate
  • How to improve communication between different parties

Contact our Sodium Valproate Claims Solicitors

If you were wrongly prescribed Sodium Valproate and your baby developed physical and developmental defects you could be entitled to compensation. For more information on our ‘No Win No Fee‘ Sodium Valproate compensation claims or to start your free case evaluation, contact our medication negligence team today on 0333 577 9444, email cn@devonshires.co.uk or complete our online form.

Sodium Valproate: The Background and Risks

Sodium valproate is an epileptic drug prescribed to patients to control seizures. It is also prescribed for bipolar disorder, pain management and migraines. Sodium valproate and related medicines are commonly known by brand names including Epilim, Episenta and Depakote. The drug was introduced to the market in 1974, with guidance for doctors which included a warning about the possible risk of birth defects.

Although the drug is no longer prescribed to women of childbearing age unless they are on a Pregnancy Prevention Plan (PPP), approximately 27,000 women who fall into this category take valproate.

Scientific Data

Data on the risks of valproate use during pregnancy was published in academic literature in the 1980s. This suggested an association between sodium valproate exposure in utero, and physical malformations, with the ‘Foetal Valproate Syndrome’ (FVSD) being described in 1984.

A lack of awareness of FVSD among health, social care and educational providers has led to delays in diagnosis.

Birth Defects Following Sodium Valproate Use by Pregnant Women

Birth defects seen when mothers take valproate during pregnancy include:

  • Spina bifida (where the bones of the spine do not develop properly)
  • Facial and skull malformations (including cleft lip and palate, where the upper lip or facial bones are split)
  • Malformations of the limbs, heart, kidney, urinary tract and sexual organs.

In women who take valproate while pregnant, about 3–4 children in every 10 may have developmental problems. The long-term effects are not known.

The effects on development can include:

  • Being late in learning to walk and talk
  • lower intelligence than other children of the same age
  • poor speech and language skills
  • Memory problems.
  • Greater likelihood of autism or autistic spectrum disorders.
  • Greater likelihood of developing symptoms of attention deficit hyperactivity disorder (ADHD).

(Source: https://www.gov.uk/guidance/valproate-use-by-women-and-girls)

According to the Medicines and Healthcare products Regulatory Agency (MHRA):

  • Up to four in 10 babies are at risk of developmental disorders if sodium valproate is taken during pregnancy
  • One in 10 is at risk of birth defects

Lack of Awareness of the Risks of Sodium Valproate Amongst Women and Girls

According to a recent survey by three epilepsy charities, Epilepsy Action, Epilepsy Society and Young Epilepsy, many women and girls were not aware of the risks of taking the drug when pregnant.

According to the survey:

  • Nearly half of pharmacists are not discussing the risks of taking sodium valproate when dispensing the drug to women.
  • 11% women who are currently taking the epilepsy medicine valproate are unaware of the possible risk of birth defects if taken in pregnancy. 
  • 18% don’t know that, when taken in pregnancy, the medicine could also cause learning and developmental delays in children.
  • 44% of participants said they had not discussed the risks of taking the medicine with their health professionals in the past 12 months
  • Only 41% of the respondents taking valproate said they had signed an Annual Risk Acknowledgement Form. This form is a written record that women and girls taking valproate are aware of the risks and shows they have discussed options for alternative treatment where necessary. 

The results of this survey were shared with the team conducting The Independent Medicines and Medical Devices Safety Review, chaired by Baroness Julia Cumberlege CBE DL.

Clare Pelham, Chief Executive at the Epilepsy Society said:

“So much of our NHS is outstanding, but the same cannot be said about all our health quangos. While we receive daily updates on coronavirus, the MHRA seems unable to warn women with epilepsy about serious risks to their unborn child if they take sodium valproate. Living with a disabled baby is life-changing for the families affected. And yet there are still no effective communications in place to warn many of the women at risk of this possibility. Our survey shows that despite all their repeated assurances that nothing the Medicines Agency has done in recent years to warn women has made any significant difference. They need to do better.”

Simon Wigglesworth, deputy chief executive of Epilepsy Action, said:

“It’s simply unacceptable that some women with epilepsy are still in the dark about the dangers of taking valproate in pregnancy. Just one woman unaware of the serious impact it could have on her unborn child is one woman too many. With a wealth of resources now available for health professionals to facilitate conversations, there is just no excuse for not explaining the risks to every woman taking valproate. Change needs to happen now to prevent babies being needlessly harmed and the devastating, life-long impact this has on families.”

Mark Devlin, chief executive of Young Epilepsy, said:

“It is shocking to hear that up to 1 in 5 women taking valproate remain unaware of the potential severe risks of its use in pregnancy. Young women and girls who have epilepsy – as well as their parents or carers – must have the information they need to make fully informed choices on the appropriate treatments available. The advice on valproate use and its associated risks will vary depending on a young person’s age and broader needs. This survey tells us that much more needs to be done urgently to ensure information is made accessible and understandable to young women of different ages and abilities.”

The Report Findings

Only July 8 2020, the Independent Medicines and Medical Devices Safety Review published its report on the experiences of women who had been given valproate, Primodos (norethisterone/ethinylestradiol; Schering) or pelvic mesh.

The report noted:

“We believe that it has taken far too long for serious action to be taken to reduce the number of women who take sodium valproate during pregnancy while unaware of the risk. Women were not given the information they needed to make an informed choice, and despite the efforts of the valproate toolkit and the PPP, too many women still do not have this information”

It also estimates that, each year, “hundreds” of babies are born “exposed to sodium valproate, despite the teratogenic risk being well recognised and undisputed”.

Recommendations

The report recommended:

  • a register of all women taking antiepileptic drugs who become pregnant, which would include mandatory data reporting on them and their children over lifetimes.
  • all women currently on sodium valproate should be contacted for a medication review.
  • the establishment of an independent patient safety commissioner and an independent redress agency for patients harmed by medicines.
  • the MHRA needs “substantial revision” in terms of adverse event reporting.

Baroness Julia Cumberlege, who chaired the review, said the report “makes for uncomfortable reading”. She said:

“I have conducted many reviews and inquiries over the years, but I have never encountered anything like this; the intensity of suffering experienced by so many families, and the fact that they have endured it for decades,” she said.

“Much of this suffering was entirely avoidable, caused and compounded by failings in the health system itself.”

Use of Valproate Medicines in Psychiatry

Although Sodium Valporate use in the UK is to treat eplipeloc seizures, Valproate medicines were licensed in 2001 for the treatment of manic episodes associated with “bipolar disorder, and have other uses in psychiatric practice, migraine prophylaxis and neuropathic pain management.

Psychiatric uses include: treatment of manic episodes; augmentation of antidepressant drug treatment; and prophylaxis to reduce episodes of bipolar or unipolar disorder”.

Despite the risks associated with the drug being published for some time, research conducted in 2018 suggested that many women of childbearing age treated for bipolar disorder with valproate – were not aware of the risks to the unborn child.

Professor David Baldwin of the Royal College of Psychiatrists (RCPsych) advised the review and noted that other medication should be prescribed:

‘there are always alternatives to valproate that have similar effectiveness and roughly similar tolerability’.

Compensation For Birth Defects Caused by Medication

Devonshires Claims represents a claimant who was exposed to a therapeutic drug in utero and this has caused extensive damage. We are experts in the field and we would be happy to discuss these issues with any woman or child who feels they have been affected.

Our experienced medical negligence solicitors will review your medication or prescription drug error case and determine if you have the grounds for a compensation claim. We can also advise on the potential compensation available. Devonshire Claims provides a ‘No Win – No Fee’ agreement for victims of medical negligence. This means that there are no upfront costs to start your medication errors claim and no costs to pay if your claim is unsuccessful*. Contact our claims experts today to start your free no-obligation case evaluation. Call us on  0333 577 9444, email cn@devonshires.co.uk or complete our online form.

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