New safety measures are now in place to reduce the risk of harms from the anti-seizure medicine valproate. Valproate also has the following brand names: Epilim, Depakote, Convulex, Episenta, Epival, Sodium Valproate, Syonell, Belvo and Dyzantil.
For some people, valproate may be the most suitable treatment for their epilepsy.
Please do not stop taking valproate without advice from your healthcare professional. If you are worried about the risks of valproate, talk to your doctor, nurse, pharmacist or another healthcare professional.
On 22 January 2024 the MHRA released new safety information resources to support the new rules for prescribing valproate. Below are some of the most important things to know from their updated patient guide:
- Never stop taking valproate before talking to your specialist first. Not taking medication as prescribed can increase the risk of a seizure.
- During your first visit, your epilepsy specialist will talk to you about the risk acknowledgement form. They will ask you to sign it and keep a copy of it.
- A second specialist will also review your treatment and sign the form. A second specialist can review your treatment in different ways. You will not need an appointment to see another specialist unless you wish to do so.
- If you are a male patient (aged under 55 years) who has not used valproate before or a female patient (aged under 55 years): you should only use valproate when two or more specialists have agreed that your epilepsy does not respond to other treatments.
For girls and women:
- Valproate can seriously harm an unborn baby when taken during pregnancy.
- You should not take valproate unless two specialists have agreed that your condition does not respond to other treatments and the benefits outweigh the risks.
- To reduce the risk of pregnancy, use birth control (contraception) that has been recommended by a healthcare professional.
- If you think you are pregnant, make an urgent appointment with your GP. Your GP will refer you immediately to your specialist who will then advise you further.
- If you are thinking about having a baby talk to your GP so they can refer you to your specialist urgently. Do not stop using your birth control until you and your specialist agree on what treatment option would be best for you.
- You should see your specialist regularly, at least once a year. Your specialist should talk to you about the Annual Risk Acknowledgement Form and complete it with you.
- Your specialist will speak with you and another specialist to decide whether valproate is the best treatment for you. If they decide valproate is not the best treatment for you, you may be switched to a different medicine.
For boys and men:
- You should not start taking valproate unless two specialists have agreed that your epilepsy does not respond to other treatments and the benefits of valproate outweigh the risks.
- Valproate may cause infertility in men. In some patients their fertility may return after treatment is stopped or the dose is reduced.
- Some toxic effects on the testes (testicles) have been seen in animals, but it is unclear what this means for humans.
Earlier this month we shared that the Medicines and Healthcare products Regulatory Agency (MHRA) updated their advice for all males taking valproate. They advised that:
“Male patients on valproate who are planning a family in the next year should talk to their healthcare professional about their treatment.”
Please do not stop taking valproate without advice from your healthcare professional. If you are worried about the risks of valproate, talk to your doctor, nurse, pharmacist or another healthcare professional.
