Sodium valproate, usually referred to as just ‘valproate’, is used to treat epilepsy and bipolar disorder. It can also prevent migraine. You may be more familiar with the brand names of medicines containing valproate which include Epilim® and Depakote®.
Research shows that valproate can seriously harm an unborn baby when taken during pregnancy. Birth defects include spina bifida (where the bones of the spine do not develop properly), malformations of the face, eyes or certain organs, and hearing problems. Where valproate is used during pregnancy, around 10 babies in every 100 will have a birth defect. In comparison, for pregnancies in which valproate is not used, around 2 to 3 babies in every 100 will have a birth defect.
In January 2024, strict guidelines were released:
- All new patients prescribed valproate aged under 55 years, two specialists must agree that your condition does not respond to other treatments or other treatments are not tolerated.
- For people with female reproductive organs, aged under 55 years taking valproate, two independent specialists must agree that your condition does not respond to other treatments or other treatments are not tolerated and document this at your next annual review.
- For people with male reproductive organs new information about the risks associated with use of valproate in male patients should be shared.
In addition, if you are under 55 and are able to get pregnant, your specialist will put you on the UK Valproate Pregnancy Prevention Programme. This is to reduce the risk of you getting pregnant whilst using valproate. On this programme, you must:
- use highly effective birth control such as an intrauterine device (coil) or implant the whole time you are taking valproate
- complete an ‘annual risk acknowledgement form’ to confirm that you understand and agree to follow the rules of the pregnancy prevention programme
You may find this information worrying but it’s important that you do not stop taking valproate without checking with your specialist or GP first.
If you find out that you are pregnant, you must seek expert medical help within the next 24 hours. Healthcare professionals will help you stop using valproate as quickly and as safely as possible.
If you are not pregnant but want to try for a baby, make an urgent appointment with your GP. They will refer you to a specialist who will be able to give you the best advice. Do not stop using birth control until you and your specialist have agreed on the best treatment option for you.
If you would like to know more, the NHS website has more information on valproate.
You can report any side effects whilst taking valproate to www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.