Valproate; guilty until proven innocent?
Why UK rules on a life-saving epilepsy medicine don’t make sense
Jane Hanna OBE; SUDEP Action Director of Policy and Influencing, and Professor Heather Angus-Leppan; Consultant Neurologist and SUDEP Action champion debunk the myths and confusion around sodium valproate medicine restrictions on boys and men. This is in light of the latest statement by the PRAC committee. Here we share what people with epilepsy can do to get access to the right medication for them, at the right time and the importance of balanced, well-rounded epilepsy risk discussions.
This is the first of a series of two on the current UK valproate restrictions for all people with epilepsy under the age of 55.
Valproate is a medicine that helps many people with epilepsy, bipolar disorder or migraines. It can be one of the most effective treatments for stopping certain types of seizures.
Restrictions on boys and men
But in the UK, since 2024, boys and men who take valproate face strict rules:
- They should avoid having children while taking it
- They may be told to stop taking valproate
- They can only start valproate if two specialists sign it off
These rules were made because of a worry that if a father takes valproate, it might harm his future children.
There is no good evidence that valproate harms children when the father takes it
By 2026, several large, high‑quality studies on real people showed:
- No increase in developmental problems in children whose fathers took valproate (one study looked at over 2,000 children)
- No difference in fertility for men taking valproate (one study looked at 90,000 men)
These results match other big studies and reviews published in 2024 in high quality scientific publications.
Current regulations are therefore based mostly on:
- Animal studies on rats, which don’t match how the drug works in humans
- Weak or unpublished human data, including studies with errors or bias
Two large human studies available before the rules were introduced in 2024 showed no link between fathers taking valproate and problems in their children.
Why the current restrictions are harmful
- It may deny patients an effective treatment option
- It may increase risks from uncontrolled epilepsy and worsen mental health
- It is known that 30-40% of men or boys who were taking valproate and have been weaned off it have had breakthrough seizures, and some have died as a result of SUDEP
- Other harms from breakthrough seizures may include time off school or work or caring for family
- It reduces patient choice. Some patients are making decisions about what medication to take without being informed of wider epilepsy risks (only medication side-effect risks), so aren’t able to make the best choice for them and their epilepsy
- For those who are allowed to start valproate it requires two clinical signatures at a time when the waiting lists for epilepsy are unsafe in many areas – epilepsy is a cliff-edge condition and delay increases risks
- Waiting lists have worsened for all with epilepsy
Back in 2023, epilepsy charities and medical experts wrote to the UK Health Secretary asking the government to pause the new valproate rules for men and boys. They wanted proper public consultation first, because the rules were about to be expanded to everyone under 55.
But the government went ahead anyway — without doing a national impact assessment or listening to how the rules might affect different groups of people. This made the UK’s rules some of the strictest in the world.
In 2024, SUDEP Action wrote again to the new Health Secretary. Big media outlets like Channel 4, UnHerd, and the New Statesman also reported on the issue.
Even though doctors can prescribe valproate if someone really needs it, the system makes it difficult because:
- Doctors must mention a weak study that supports the restrictions
- They don’t have to mention the large, high‑quality studies showing no risk
- They don’t have to explain how effective valproate is for dangerous seizures
- They don’t have to use a SUDEP and Seizure Safety Checklist
Right now, the NHS is required to track how many valproate prescriptions go down — but not what happens to people whose seizures get worse because they can’t access the best medication.
What can you do if you think you need valproate and are not able to get it
Your medical team is responsible for explaining the evidence and your options and this includes your right to person-centred evidence-based care and treatment. The MHRA has said no one should be denied valproate if they need it. The restrictions are there as a precautionary measure for future unborn and hypothetical children. You can make medical professionals aware that you know that the MHRA have said no one who needs valproate should be refused it. You can ask; is there good evidence that risks actually apply to you? What is the best known most effective medicine for generalised seizures? Refer to the good practice and NHS RightCare recognised SUDEP and Seizure Safety Checklist and ask them for their advice. Let your specialist know what your life priorities are. If you want seizure freedom or improved seizure control that ought to be central to the shared decision about treatment.
How do we get the restrictions changed?
SUDEP Action campaigns every day for person-centred evidence based care; access to timely anti-seizure medication; for SUDEP and Seizure Safety Checks to help clinicians and patients make informed choices together. Extreme regulations were diluted as a result of our work, but they remain extreme.
If you want to help or learn more, you can contact us at info@sudep.org and mention “valproate” in your message.
Help and resources
SUDEP Action provide a range of free resources to help improve the safety of people living with epilepsy and are the only charity dedicated to supporting anyone bereaved by epilepsy.
We are fighting for a future where there are no preventable epilepsy deaths, and where anyone bereaved can access specialist support if they wish. Help us make this future a reality by signing up to our e-news (form at bottom of this page) and consider a donation so we can continue to keep our services free to those who need them.
If you have epilepsy:
- Free EpSMon app
- Free Leaflets and risk information
- Download a Charlie Card to help you if you struggle to access your prescribed medication
- Join our group of epilepsy champions fighting for change on this issue – email info@sudep.org
If you have been bereaved by epilepsy:
- Share information with the Epilepsy Deaths Register research platform – your loved one’s death can help us fight for change
- Free bereavement support services
- Help with inquests and investigations following your loved one’s death
- Join our group of epilepsy champions fighting for change on this issue – email info@sudep.org
- Meet others bereaved by epilepsy at our Coffee Clubs
If you are a health professional supporting people with epilepsy:
- Free SUDEP and Seizure Safety Checklist– to support your epilepsy risk conversations (adult and paediatric versions available)
- Free Leaflets and risk information for your patients
- Share information with the Epilepsy Deaths Register research platform – if one of your patient’s sadly dies, sharing what information you have can help us fight for change
- You may wish to also look at this South-East Clinical Network Resource Video of perspectives clinicians and patients.
References
- Razaz N, Soderling J, Tomson T, et al. Risk of neurodevelopmental disorders associated with paternal use of valproate during spermatogenesis. J Neurol Neurosurgy Psychiatry 2026;1–9.
- Tomson T, Muraca G, Razaz N. Paternal exposure to antiepileptic drugs and offspring outcomes: a nationwide population-based cohort study in Sweden. Journal of Neurology, Neurosurgery & Psychiatry 2020;91:907–13.
- Christensen J, Trabjerg BB, Dreier JW. Valproate Use During Spermatogenesis and Risk to Offspring. JAMA Network Open 2024;7:e2414709.
- Christensen J, Trabjerg BB, Dreier JW. Risk of Neurodevelopmental Disorders and Paternal Use of Valproate During Spermatogenesis. JAMA Network Open 2025;8:e2512139. 5 Honybun E, Rayner G, Malpas CB, et al. Paternal exposure to antiseizure medications and offspring outcomes: a systematic review. J Neurol Neurosurg Psychiatry 2024;96:15–25.
- Angus-Leppan H, Moghim MM, Cock H, Kinton L, Synnott Wells M, Shankar R. Valproate risk form-Surveying 215 clinicians involving 4775 encounters. Acta Neurol Scand. 2020 Jun;141(6):483-490. doi: 10.1111/ane.13231. Epub 2020 Mar 10. PMID: 32072612.
- Hanna J, Angus-Leppan H. Changes to MHRA regulations on 13 Feb 2025 valproate are not enough Valproate: Men are advised to use contraception owing to risk of neurodevelopmental disorders in children. BMJ 2024; 386 doi: https://doi.org/10.1136/bmj.q1957 (Published 06 September 2024).
