New rules for taking sodium valproate
Sodium valproate is an epilepsy medicine that has risks to an unborn child if taken during pregnancy. It might also affect fertility in men. New prescribing rules have been announced to try to make sure these risks are avoided where possible.
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What is changing?
The MHRA is a government body that regulates medicines and medical devices. They have announced new measures that say “no one under the age of 55 should be initiated on valproate unless two specialists independently consider and document that there is no other effective or tolerated treatment.”
This means that two specialists will have to agree whether people under the age of 55 can start taking sodium valproate. These new measures will also apply to men and boys.
There have been other rules in place for women and girls for some time, and these will still apply. You can find out more about these and the Pregnancy Prevention Programme here.
So far, the MHRA have only released information for healthcare professionals. This can be found here:
They will be sharing more information for people with epilepsy soon.
The NHS previously released a valproate decision making tool to explain the risks and benefits of taking valproate for anyone who could become pregnant.
When will this happen?
The new measures will start from 31st January 2024 for men and women aged under 55 who are planning to start taking valproate.
Women and girls who are already taking valproate will be reviewed at their next annual specialist review. At this review, you will now need to have a second signature on your Annual Risk Acknowledgement Form if it is agreed that you should continue taking sodium valproate.
Men and boys currently taking valproate will start to be reviewed later in 2024. MHRA have not yet given a firm date for this.
I’m currently taking valproate. Does this mean I’ll have to stop?
You don’t need to take any action now. You might be worried about these measures, but we understand from MHRA that nobody currently taking valproate will have their medication taken away against their will.
You may also know valproate as: Epilim, Episenta, Epival, Dyzantil or Depakin.
It’s important that you don’t stop taking your epilepsy medicine without talking to your doctor.
Supporting you with these changes
Epilepsy Action have raised concerns with MHRA about the impact that these new measures could have. We want everyone with epilepsy to be able to make informed choices about their treatment options.
You can find out more about this on our campaign page.
If you would like to talk to someone about how to have the conversation with your doctor, or about anything else related to valproate, we are here for you.
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Has my child been affected by valproate?
Foetal valproate syndrome (FVS) is a rare condition that is caused by exposure of the unborn baby to sodium valproate during pregnancy. There isn’t a test that can confirm a diagnosis of fetal valproate syndrome and symptoms will be different for each person.
If you are worried that your child might have been affected by taking valproate during pregnancy, you can discuss this with your doctor.
You could also contact a support network such as:
Organisation for Anti-convulsant Syndrome (OACS)
Tel: 07904200364
Email: oacscharity.org@gmail.com
Valproate Victims
Webpage: pharmaconsent.org
What about other anti-seizure medications (ASMs)?
Some other epilepsy medicines can be also harmful if taken during pregnancy. At the moment, there are no restrictions around the use of these medicines in pregnancy. But the MHRA are looking at this. In time, the epilepsy medicine topiramate is likely to also become part of the Pregnancy Prevention Programme (PPP). This will mean that women and girls prescribed topiramate will be asked to:
- Sign a Risk Acknowledgement Form to confirm they have been told and understand the risks of taking topiramate in pregnancy
- Make sure they are on highly effective contraception if necessary
- See their specialist at least every year
It is possible that other epilepsy medicines will be brought into the PPP in the future. We will update this page when more information is available.
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