The Sodium Valproate Scandal: Have You Been Affected?

Some of you might have heard of sodium valproate and the effects it can have on unborn children when administered to their pregnant mother. 

The sodium valproate scandal became public knowledge back in 2018, and many women have sought compensation for having received negligent medical care. But what exactly is it, and what’s the scandal?

In this post, we’re going to tell you what sodium valproate is and what it’s used for, and how the scandal around the drug unfolded. We’ll then discuss what the response to the scandal has been, and how you can make a claim for compensation if you or your children have been affected. 

What is Sodium Valproate?

Before we get into the scandal, we’re going to briefly outline what the sodium valproate uses are, and how it can be harmful. 

Sodium valproate is a drug used to treat people with epilepsy and bipolar disorder, and is occasionally used to prevent migraines. You can only get sodium valproate on prescription, or via an injection at the hospital.

It’s recommended that any woman who is pregnant, or expecting to become pregnant, doesn’t take the drug. In fact, the drug isn’t recommended for:

• Women who might get pregnant
• Young women or girls who are having sex
• Women who are pregnant

The reason sodium valproate shouldn’t be taken by pregnant women is because it can seriously harm their unborn child. It can cause foetal valproate syndrome (FVS), cognitive difficulties, learning disabilities and autism, as well as some physical abnormalities.

There are lots of sodium valproate trade names so, if you’re pregnant and are being treated for epilepsy or bipolar disorder, check the names below to check if you’re taking them:

• 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 was the Sodium Valproate Scandal?

The fact that sodium valproate is harmful to pregnant women is not new information. That said, there are have been claims from patients who say they weren’t told of the effects when it was first prescribed to them. This means that medical negligence has played a part in the consequences they may have experienced since.

The drug’s manufacturer, Sanofi, said sodium valproate had been “made available to physicians to treat epileptic patients in the 1970s”. But, information on the risks was not made widely available until many years later. 

There has been a visible label on the packet since 2016 warning of the potential harm to unborn children. However, many women were not told these risks in person when it was prescribed by their doctor.

In 2018, research came out showing that 1 in 4 women weren’t given any information about the risks of the drug on an unborn child. Due to this, an estimated 20,000 children in the UK have been left with disabilities caused by sodium valproate since the 1970s.

On top of this, new research from Konkuk University in South Korea on mice in the lab suggested that the disabilities caused by sodium valproate could be encoded in DNA and passed down to future generations. 

The university’s Professor of Pharmacology, Chan Young Shin, said he found evidence “the compound could cause autism spectrum disorder trans-generationally”.

A Case Study

Sue Jenkinson, a mother from Liverpool, took sodium valproate while she was pregnant, and both of her daughters developed FVS. Her daughters have now had children of their own who they believe are showing signs of the condition. Some symptoms that may show in children include:

• Facial characteristics, including a high, broad forehead, wide bridge of the nose, thick lower lip, cleft palate or lip, and more.
• Birth defects of the brain and spine, like Spina Bifida.
• Congenital heart defects.
• Genital abnormalities, for example undescended testicles, or where the urethra forms underneath where it should form.
• Skeletal abnormalities, like long fingers that overlap, clubbed feet, and stiff joints.
• Developmental delays and potential learning difficulties and disorders, like ADHD or autism.

In response to this scandal, Norman Lamb, a former minister for care and support, started a campaign calling for the government to back compensation claims made by affected families. The families themselves called for an inquiry into the scandal and, in February 2018, the UK government launched a review into sodium valproate. They also looked into two other treatments undergoing similar scandals.

How is the Scandal Being Dealt With?

Now that you have an idea of what the sodium valproate scandal is, we’re going to share with you how the scandal was dealt with at the time, and what’s being done about it now.

Then

At the time of the scandal, new regulations were introduced by the Medicines and Healthcare Products Regulatory Agency (MHRA) around the prescription of sodium valproate to women of childbearing age. These measures were implemented to make sure all women who take the drug are:

• Informed of the risks
• Advised on the importance of contraception
• Have their treatment reviewed annually 

The MHRA also updated the license for sodium valproate so that doctors who prescribe it have to sign female patients up for a Pregnancy Prevention Programme. This programme makes sure the yearly treatment reviews are carried out, signed off by the patient, and the use of contraception is encouraged. 

Now

As we mentioned in the last section, a review was launched in February 2018 to look into the scandals of sodium valproate and two other treatments. The review was undertaken by Baroness Cumberlege, and the results were discussed in parliament on 9^th July 2020. 

From the discussion, it’s clear the government hasn’t fully decided what to do about the cases. Some MPs suggest that all the women affected should receive compensation, and others want criminal charges brought against the manufacturers.

Since that discussion, nine recommendations have been made by the government on what should be done about the scandal:

1. An apology should be issued by the Government to all the families affected by Sodium Valproate, Primodos and Pelvic Mesh (the two other scandals discussed in the review).
2. An independent Patient Safety Commissioner should be appointed to listen to patients and seek improvements to patient safety whilst holding the healthcare system to account.
3. An independent Redress Agency should be implemented to help resolve any disputes.
4. A discretionary payment scheme should be set up to meet the cost of providing additional support to those who’ve experienced ‘avoidable harm’.
5. Separate specialist centres should be set up to provide treatment for those affected by Sodium Valproate, Primodos and Pelvic Mesh.
6. Extensive revision should be made to the way the MHRA gathers data and raises awareness of its role as a protector of the public.
7. A central database should be set up to record details of device implantation.
8. Transparency should be provided on the financial links between doctors and pharmaceutical companies.
9. A task force should be implemented to make sure the other eight recommendations listed above are followed.

How to Make a Claim if You’ve Been Affected by Sodium Valproate

Just because the government is dragging its feet on what to do for the families affected by sodium valproate, it doesn’t mean you can’t make an individual claim against your doctor. After all, children with FVS, autism, mental difficulties, and physical impairments often require lifelong care which is difficult for parents to provide on their own. 

In an instance where the patient is completely unaware that the drug would have any harm on their unborn child, claiming compensation against the NHS is the only recourse a parent has to make sure their child is provided for. 

Usually there are time limits on claiming compensation for pregnancy injuries. However, in this case, the cause of the birth defect was only made public recently. So, you should still have time to put in a claim. 

If you want to make a claim, speaking to a local solicitor, or one who’s an expert in these types of medical negligence claims, is the best way to go. They’ll be able to advise you on how solid your case is.

What Now?

Today, we’ve covered what sodium valproate is, and how the scandal came about. We’ve also discussed what the government’s response to the scandal has been, and how you can make a claim for compensation if you’ve been affected.

It’s difficult to know where things will go from here. The government has acknowledged the scandal and are determined to make sure it doesn’t happen again in future. But, what about all the people who have already been affected?

Some MPs have suggested that compensation should be given, but it isn’t included in the government’s official recommendations. The only guaranteed recourse if you’ve been affected by sodium valproate is to take the situation into your own hands and make a claim for medical negligence. 

Hopefully you know more about the sodium valproate scandal after reading this post than you did before. We hope it’s prepared you to make an informed decision on what you should do next.