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Sodium valproate risks and rules
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Key points
- The rules and advice about taking sodium valproate have changed at different points in 2024
- This is because of the potential risks to children of people who take valproate
For women:
- There’s evidence that taking valproate in pregnancy can cause problems for a baby
- The rules apply to people under the age of 55 who are able to become pregnant
For men:
- There is less evidence about the risks for men taking valproate. It is thought that fertility could be affected, and there might be a small risk to an unborn child. The risks are lower than those for women
- The rules are different depending on whether you are already taking sodium valproate, or you are taking it for the first time
- If you are already taking sodium valproate, you and your partner should use effective contraception. Talk to your healthcare professional about the risks and your epilepsy treatment options at your next routine appointment
Key documents
Ask for medical advice before making changes to your epilepsy medicine.
Do not stop taking your medicine if you are planning to get pregnant or you’re already pregnant. Instead, speak to your GP urgently so they can get you the help and advice you need.
Stopping your medicine could cause you to have more seizures. Or your seizures might be more severe.
What is sodium valproate?
Valproate medicines are an effective treatment for epilepsy. They can also be used to treat bipolar disorder and migraines.
Valproate medicines include sodium valproate and valproic acid. Examples of brand names include Belvo, Convulex, Depakote, Dyzantil, Epilim, Epilim Chrono or Chronosphere, Episenta, Epival, and Syonell.
On this page we will use ‘sodium valproate’ or ‘valproate’ to talk about these medicines.
What are the rules about taking sodium valproate medicine?
The Medicines & Healthcare products Regulatory Association (MHRA) have set rules about how doctors can prescribe sodium valproate. The aim is to reduce the risks when people who take sodium valproate have children.
There are different rules for women and men. For men, there are differences if you’re starting valproate or already taking it. The rules will affect people in different ways. We have a summary below of what the rules might mean for you.
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Rules for transgender and nonbinary people
The guidelines doctors use when prescribing valproate medicines refer to ‘men’ and ‘women’. They use these words to refer to your sex assigned at birth. This may not be the same as your gender. The rules for women apply to someone assigned female at birth who is under 55. The rules for men apply to someone assigned male at birth.
The rules might not apply to you if you cannot produce sperm or get pregnant. For example, if you’ve had your womb, ovaries or testicles removed. You can speak to your doctor or epilepsy specialist nurse (ESN) about any questions you have. It’s important to keep taking your medicine until you’ve had advice from your doctor or ESN.
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Rules for women
The rules for women under 55 are:
- You should only take valproate medicines if there are no other effective treatments for you. This means other medicines do not work to control your seizures. Or if side effects from other medicines are too severe for you. Valproate may be the only effective medicine for some types of epilepsy
- Two specialists must agree that you can take sodium valproate before it is prescribed to you
- You must be on the Pregnancy Prevention Programme if you are able to become pregnant
The NHS has a decision making tool to help decide if valproate is the right medicine for you.
The Valproate Pregnancy Prevention Programme
In the UK, doctors can only prescribe valproate to someone who can get pregnant if they are on the Valproate Pregnancy Prevention Programme. The aim is to make sure that people taking valproate medicine are aware of the risks in pregnancy.
People must use highly effective contraception to avoid becoming pregnant. This may include implants and intrauterine devices (IUDs). You can find out more on our contraception webpage.
Risk Acknowledgement Forms
If you are prescribed valproate medicines, you will be asked to sign a Risk Acknowledgement Form. This is to show that you understand the risks of getting pregnant while taking valproate and why you need to be on effective contraception.
The two specialists who approve your treatment will also sign this form.
An epilepsy specialist should review your treatment at least once a year after that. They will ask you to sign the form again at each review.
If your circumstances change, two specialists will need to sign the form again.
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Rules for men
The rules for men taking valproate were introduced in January and September 2024. They apply whether you want to have children or not. They’re different for men who are already taking valproate and men who want to start taking it.
Uncontrolled seizures can be dangerous and increase your risk of sudden unexpected death in epilepsy (SUDEP). You shouldn’t make any changes to your medicine without talking to a GP or epilepsy specialist first.
Men who might be starting valproate
Doctors are unable to start prescribing sodium valproate to men under 55 unless:
- It has been approved by two specialists and
- There are no other treatments that help to control your seizures. Or, if side effects from other medicines are too severe
Your doctor will talk to you about your treatment options and any concerns you may have. They will also ask you to sign a Risk Acknowledgement Form. This is to make sure you understand the risks. You will be asked to sign a form at your review each year.
You should follow the advice below about contraception and planning a baby.
Men currently taking valproate
The MHRA say that all men should know about the possible risks of taking sodium valproate.
You should discuss the risks of taking valproate at your next treatment review with your GP. You can ask for an appointment sooner if you’re thinking of starting a family. Or, if you want to talk about any concerns that you have about the risks.
Contraception
The MHRA say that you should use effective contraception if you’re having sex with someone who could get pregnant. You should continue to do this for 3 months afterwards, if you stop taking it.
There isn’t enough research yet about whether the risks can still happen after 3 months.
The MHRA advise that your partner should use contraception as well as condoms if they can get pregnant. This is because condoms are very effective when used correctly, but evidence shows that they’re often not used correctly. The NHS website has more information about how effective different types of contraception are.
Planning a baby
Your GP can refer you to a specialist if you’re planning to have a baby. They will be able to help look at the risks of different treatment options. They might discuss switching you to a different epilepsy medicine. Or it may be safer for you to keep taking sodium valproate.
Speak to your GP if your partner is already pregnant. They will be able to refer you for specialist advice.
You’re also advised to avoid donating sperm while taking sodium valproate, and for 3 months after stopping.
The MHRA have produced a patient advice sheet. They are also working to update other information, like the patient guide.
Don’t stop taking your medicine without speaking to a doctor. You can also talk to your epilepsy specialist nurse (ESN), if you have one.
Epilepsy Action’s helpline is available if you have more questions.
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I’m taking valproate and want to get pregnant. What should I do?
Speak to your doctor if you’re taking valproate and are thinking about having a baby. Until then, keep taking your epilepsy medicine and using effective contraception.
They can arrange for you to see an epilepsy specialist for advice about planning your pregnancy. They will decide whether you should change your medicine or stay on valproate. Ideally, they will change your medicine a long time before you become pregnant. This is so your seizures are well controlled by the time you get pregnant.
They might advise you to continue taking valproate while you are pregnant if it is the only effective medicine for you. Uncontrolled seizures may be more of a risk to you and your baby than the risks from valproate. In this case, they should refer you to see a specialist in prenatal medicine. These are healthcare professionals trained to look after pregnant people whose babies have a higher risk of possible complications.
Epilepsy Action has more information about planning a baby.
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I’m already pregnant. What should I do?
Do not stop taking valproate unless your doctor advises you to. Stopping any epilepsy medicine suddenly could cause you to have more seizures. Or your seizures might be more severe. This could be harmful to you and your baby.
Uncontrolled seizures can increase the risk of sudden unexpected death in epilepsy (SUDEP) for some people. Taking your epilepsy medicine can help to reduce your risk of SUDEP.
Talk to your doctor as soon as possible if you haven’t had advice about taking your medicine during pregnancy. This might be the case if you have an unplanned pregnancy. Your doctor should arrange for you to see a specialist to get the advice you need. In some cases, your specialist may advise you to switch to another medicine. If so, they should tell you how to do this safely.
For some people, valproate may be the only effective medicine. Your specialist might advise you to keep taking it during pregnancy. They should arrange for you to see a specialist in prenatal medicine. These are healthcare professionals who care for people with high-risk pregnancies.
Breastfeeding
You might be worried about breastfeeding if you are taking sodium valproate. The levels of sodium valproate in your breastmilk will be low and unlikely to harm your baby. But you should discuss this with your doctor, midwife or epilepsy specialist nurse.
The NHS website has more information about taking sodium valproate while breastfeeding.
Epilepsy Action has more information about pregnancy and epilepsy.
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I’m taking valproate and I’ve no plans to get pregnant. How will the rules affect me?
The rules will apply to you if you are physically able to get pregnant, even if you do not want to. If other treatments aren’t suitable for you, your doctor may prescribe you valproate. They should only do this if you’re on the Pregnancy Prevention Programme.
The doctor must make sure you:
- Understand the risks of taking valproate during pregnancy
- Understand the need to use effective contraception to avoid getting pregnant
- Sign a Risk Acknowledgement Form to show that you understand the risks
You should use effective contraception, even if you’re not currently sexually active.
Your specialist will ask you to take a pregnancy test if you are starting valproate. This is to make sure you are not pregnant. They may ask you to repeat this test at regular intervals.
You might not have to sign the form or be on contraception if your doctor believes there isn’t a risk of you getting pregnant. For example, if you’ve been through menopause or have had a hysterectomy (to remove your womb). This might also apply to people in same sex relationships or some people with learning disabilities. However, it is up to the specialists to make this decision.
Sometimes they may still ask you to complete the form. This is to make sure you are aware of the risks if your situation was to change in the future.
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Do the rules apply to my child taking sodium valproate?
Your doctor should explain the risks of valproate to you and your child. They should do this when they first start taking it. This is so you are prepared and informed for the future.
If your child is a boy and is starting valproate, two specialists will need to approve your child’s treatment. The rules are the same for men and boys.
If your child is a girl, you should contact their GP when they first start their period. They will then refer them to their specialist. The specialist will decide whether to keep your child on sodium valproate or switch to another medicine. This decision will be made with you, your child, and another specialist. The specialist will discuss contraception if your child does stay on valproate. They may also do a pregnancy test as a precaution.
Sometimes a specialist may review your child’s medicine when they change from a children’s clinic to an adult one. This might be at a transition service if there is one available in your area.
Epilepsy Action has online support groups for parents of children with epilepsy.
Support for you
Epilepsy Action is here to support you.
Our helpline can help to answer any questions you might have about sodium valproate. We also have support groups where you can connect with other people and share your experiences.
What are the risks of taking valproate medicines during pregnancy?
Taking valproate can cause problems for unborn babies if it’s taken during pregnancy. The rules for taking sodium valproate are in place to try and avoid these risks.
These problems include:
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Birth defects
Valproate medicines can affect how a baby develops in the womb. This can cause problems with how their body parts grow or how they work. These are called physical birth defects.
You also might see or hear them being called congenital malformations or congenital abnormalities.
In women who take sodium valproate during pregnancy, around 1 in every 9 babies will be born with birth defects. This compares with 1 in 45 in the general population.
Some of these problems include:
- Spina bifida. This is where the bones of the spine do not develop properly
- Facial and skull malformations. This can include cleft lip and palate, where there is a split in the upper lip or roof of the mouth. It happens if a baby’s face doesn’t fully join together in the womb
- Problems with the development of the hands and feet, heart, kidney, urinary tract and sexual organs
- Issues with the eyes not developing properly in the womb. This can cause problems with eyesight
- Problems with hearing or deafness
It’s recommended to take folic acid if you’re trying to get pregnant or in early pregnancy. A higher dose of 5mg a day is recommended for people taking sodium valproate. This needs to be prescribed by a doctor. Taking folic acid can help reduce the risk of conditions like spina bifida. But there’s not enough evidence to show that folic acid can protect against the risks of sodium valproate.
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Learning and development problems
Taking valproate medicines during pregnancy can lead to learning and development problems in children. If 100 people take valproate during pregnancy, 30 to 40 of those children will have learning and development problems. In the general population of the UK, around 2 or 3 out of every 100 children have a learning disability.
Problems with learning and development include:
- Walking or talking later than other children of the same age
- Poor speech and language skills
- Memory problems
- Lower intelligence than other children of the same age
- An increased risk of autism and Attention Deficit Hyperactivity Disorder (ADHD)
What are the risks for men?
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Fertility issues
There is not as much research about sodium valproate and its effects on men, compared to women. More research is needed to fully understand the risks in men.
Evidence suggests that valproate medicines can cause problems with fertility in men. This means that men may find it more difficult to get someone pregnant.
It’s possible that these fertility issues are not permanent. Some research suggests that male fertility may be improved if you stop taking valproate medicines or take a lower dose.
The patient guide mentions that sodium valproate may have toxic effects on the testicles. But this is from animal studies and it’s unclear what this means for humans.
More research in humans needs to be done to fully understand if fertility issues are reversible.
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Learning and development problems in children
Recent research has looked into children of men who have taken valproate. There are concerns that it might increase the risk of children having problems with learning and development.
A study has looked at the children of men who had taken sodium valproate within 3 months of the baby being conceived. They found that 5 in every 100 children had problems with their mental or movement development. This compares to 3 in 100 children whose fathers took lamotrigine or levetiracetam. This is a small increased risk. It’s much lower than the risk in pregnant women taking valproate.
The study doesn’t prove that valproate causes developmental problems. But the MHRA believe that it’s an important safety concern people should know about. For this reason, they introduced new advice in September 2024 for men taking valproate .
More research needs to be done to prove the link between men taking valproate and having children with developmental problems.
From this study we don’t know:
- How this risk compares to people who take different epilepsy medicines, or none at all. The study only compared men taking valproate with men taking lamotrigine or levetiracetam
- Whether there was a difference in the type of developmental problems or how severe they were
- What the risk is for men who stopped taking valproate more than 3 months before conception
Find out more
Our sodium valproate campaign
You can find out more about the campaigning work we are doing around sodium valproate.
We also want to hear about your experiences and any issues you have had.
Can other epilepsy medicines harm my baby if taken during pregnancy?
Some epilepsy medicines are not known to cause complications in pregnancy.
There are other epilepsy medicines that do have a risk of causing birth defects or learning and developmental problems. But this risk is lower than sodium valproate.
The MHRA introduced new rules for taking topiramate in June 2024. This is because of the risks to an unborn baby if it’s taken during pregnancy. Our page about epilepsy medicines and pregnancy has more information about topiramate and other medicines.
Where can I find out more?
The MHRA has produced a toolkit for women and girls about the risks of taking valproate medicines during pregnancy. It has also published a patient booklet for people taking valproate and a risk diagram for men.
The NHS website has more information about how to take sodium valproate. It also explains possible side effects.
The NHS decision making tool can to help decide if valproate is the right medicine for you.
I think my child has been affected by valproate medicines. What should I do?
You may worry that your child has been affected if their mother took valproate medicine during pregnancy. You can discuss any concerns with your GP. The doctor may refer your child to see a specialist in children’s medicine if they think this is needed.
Visit our campaigns page to see how we’re planning to improve support for families affected by this issue. The NHS Resolution website has information about claiming compensation. You could consider making a claim if you weren’t told about the risks.
You can also contact a support network such as:
Organisation for Anti-convulsant Syndrome (OACS)
OACS support all families affected by taking anti-seizure medicines in pregnancy
Helpline: 07904200364
Email: oacscharity.org@gmail.com
Valproate Victims
This charity represents people and families who have been affected by taking sodium valproate in pregnancy.
INFACT
INFACT helps anyone that has taken anti-seizure medications in pregnancy. They offer information, advice and support. They can help if you’re concerned it may have affected your baby during pregnancy.
Helpline: 01253 799161
This information has been produced under the terms of the PIF TICK. The PIF TICK is the UK-wide Quality Mark for Health Information. Please contact website@epilepsy.org.uk if you would like a reference list for this information.
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