Valproate Safety: A Care Staff Guide to the Pregnancy Prevention Programme

Valproate is a medicine used to treat epilepsy and bipolar disorder, and sometimes to prevent migraine. It can be very effective, but taken during pregnancy it can cause serious harm to the baby. Because of this, the UK medicines regulator, the MHRA, has put strict safeguards in place. Care and support staff are not prescribers, but they often support people who take valproate, and they can notice when a review is missed, when someone could become pregnant, or when a person wants to stop the medicine on their own.

This guide explains the main safety rules, what staff should and should not do, and where to find the latest guidance. It draws on the MHRA guidance on valproate use, first published in June 2025 and updated since, and on the NHS pages on sodium valproate, last reviewed in March 2025. The rules have changed several times in recent years, so always check the latest MHRA and NHS guidance.

What is valproate used for?

The NHS says sodium valproate is used for epilepsy and bipolar disorder, and occasionally to prevent migraine. It is available as capsules, tablets or liquid, as granules mixed into food or drink, and as an injection, usually only given in hospital. It is prescription only, and it is usually taken once or twice a day. Brand names include Epilim, Depakote and Convulex. Our guides to bipolar disorder and epilepsy awareness cover the conditions it treats.

Why the rules are so strict

According to the MHRA guidance, about 1 in 9 babies (11%) exposed to valproate in pregnancy have a birth defect, and about 3 or 4 in 10 have early childhood development problems. Possible outcomes it lists include spina bifida, malformations of the face, skull, limbs, heart and kidneys, hearing problems and autism, with some evidence of an increased risk of ADHD. The NHS says the risks include birth defects and learning and behaviour problems in the child.

The MHRA guidance also covers fathers: it reports that about 5 in 100 children whose fathers took valproate in the three months before conception have neurodevelopmental conditions, and states that the cause is unclear.

The Pregnancy Prevention Programme

The MHRA says valproate must not be prescribed to women or girls able to have children unless the conditions of the Pregnancy Prevention Programme are met. The NHS refers to this as the Prevent programme. In summary, the guidance sets out:

• Clinicians discuss the risks using guides, and the patient and clinician sign an Annual Acknowledgement of Risk Form.
• Female patients under 55 have the form completed at the start and at each annual review.
• Two specialists must agree at the start of treatment; one specialist is enough at later annual reviews.
• Carers, such as parents or caregivers, receive patient guides with the risk information.

The guidance also applies to patients under 55 generally. Valproate should only be started when two specialists agree that other treatments have not worked or are not tolerated and that the benefits outweigh the risks. For male patients under 55, a Male Risk Acknowledgement Form is completed at the start of treatment. The NHS says men taking valproate, and their partners, should use contraception during treatment and for at least three months after stopping, and it notes that valproate has been linked to reduced fertility in men, which may improve after stopping.

What care staff should do

The MHRA and NHS pages are written for prescribers and patients, so the points below are general good practice for care staff rather than regulatory requirements. They should be adapted to your organisation's medicines policy.

• Never encourage anyone to stop valproate. Both the NHS and the MHRA say not to stop without specialist advice, because epilepsy or bipolar disorder may get worse.
• Make sure reviews happen. If someone is on valproate, check that an annual specialist review is booked and happens, and tell the GP or specialist if it is overdue.
• Know where the paperwork is. Patient cards, leaflets and signed forms belong with the person's records.
• Act quickly on pregnancy concerns. The NHS says that if someone might be pregnant, they should contact a doctor or nurse urgently, and should not stop the medicine without advice.
• Handle conversations sensitively. Questions about contraception and pregnancy are personal. Leave clinical discussion to the prescriber, offer support and respect the person's privacy and choices.
• Follow medicines policy. Administer exactly as prescribed, record any missed doses and report side effects.

Capacity, consent and choice

People with epilepsy, bipolar disorder or a learning disability are entitled to the same information and choices as anyone else about their medicines and about having children. If you believe someone lacks capacity for a specific decision, follow the Mental Capacity Act and your organisation's procedures. Do not make decisions about contraception or medicine for them on your own.

Other medicines to be aware of

Valproate is not the only mood-stabilising medicine that needs careful monitoring. Our guide to lithium monitoring and safety covers another medicine used for bipolar disorder.

Training and CPD

Medicines safety is a core part of care work. Record what you learn in your CPD log, discuss real examples in supervision, and browse the options on our CPD pages.

Key points to remember

• Valproate treats epilepsy and bipolar disorder but can seriously harm an unborn baby.
• The MHRA says about 1 in 9 exposed babies have a birth defect and about 3 or 4 in 10 have early childhood development problems.
• Women and girls who could become pregnant must be on the Pregnancy Prevention Programme, with annual specialist review.
• Specialist agreement is needed to start valproate in anyone under 55.
• Nobody should stop valproate without specialist advice; staff should raise concerns with the prescriber quickly.

Frequently asked questions

Should someone stop valproate if they might be pregnant?

No. The NHS says they should contact a doctor or nurse urgently and not stop without advice, because stopping could make their condition worse.

Does valproate affect men?

The NHS says it has been linked to reduced fertility in men, and men and their partners should use contraception during treatment and for at least three months after stopping. The MHRA also reports possible effects on children whose fathers took it before conception.

Are these rules likely to change?

They have changed several times in recent years. Check the latest MHRA and NHS guidance rather than relying on older paperwork.

This guide is for general information and is not a substitute for clinical advice or your organisation's policies.