Research has shown that taking valproate medicine during pregnancy can harm your unborn child. Valproate medicines include sodium valproate (Epilim, Episenta, Epival, Depakote) and valproic acid (Convulex). Taking valproate medicine during pregnancy can cause birth defects and problems with a child’s development and learning.
In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) has issued rules about how doctors can prescribe valproate medicines. These rules say doctors must not prescribe valproate to women or girls of childbearing age, unless they are on the valproate pregnancy prevention programme.
What sort of problems can valproate cause?
Valproate can cause two sorts of problems when taken during pregnancy: birth defects and problems with learning and development.
In women who take valproate during pregnancy, around 1 in every 10 babies will be born with birth defects.
Birth defects happen when the baby doesn’t develop properly in the womb. Other names for birth defects include congenital anomalies, congenital malformations and congenital abnormalities.
Birth defects seen in children whose mothers took valproate during pregnancy include:
- Spina bifida (where the bones of the spine do not develop properly)
- Facial and skull malformations (including cleft lip and palate, where the upper lip or facial bones are split)
- Malformations of the limbs, heart, kidney, urinary tract and sexual organs
Learning and development problems
In women who take valproate during pregnancy, between 3 and 4 in every 10 children have problems with learning and development. The long-term effects aren’t known.
Problems with learning and development include:
- Walking and talking later than other children of the same age
- Poor speech and language skills
- Memory problems
- Lower intelligence than other children of the same age
Children whose mothers took valproate while pregnant are more likely to have autism or an autism spectrum disorder. There’s also some evidence that children may be more likely to develop symptoms of attention deficit hyperactivity disorder (ADHD).
I’m taking valproate and I’ve no plans to get pregnant. How will the rules affect me?
If you’re at an age where you could become pregnant, your doctor should only prescribe you valproate medicine if you’re on the valproate pregnancy prevention programme. This means your doctor must make sure you:
- Understand the risks of taking valproate during pregnancy
- Understand the need to use effective contraception to avoid getting pregnant while taking valproate
- Sign a form to show that you understand the risks
The MHRA says you should use effective contraception even if you are not currently sexually active. This is unless your doctor believes there is very good reason to assume there is no risk of pregnancy.
If you’re starting treatment with valproate medicine your specialist will ask you to take a pregnancy test first, to make sure you’re not pregnant. They may ask you to repeat this test at regular intervals while you’re taking valproate.
While you’re taking valproate medicine, an epilepsy specialist should review your treatment at least once a year. At each review the specialist will ask you to sign another form to show that you understand the risks of getting pregnant while taking valproate.
I’m taking valproate and want to get pregnant. What should I do?
If you’re taking valproate and want to get pregnant, speak to your family doctor. Keep taking your epilepsy medicine and keep using contraception until you have spoken to your doctor. They can arrange for you to see an epilepsy specialist for advice about planning your pregnancy. If the specialist advises you to change your medicine, they should do this a long time before you become pregnant.
I’m already pregnant. Should I stop taking valproate?
You should only stop taking valproate if your doctor advises you to. Stopping any epilepsy medicine suddenly could cause you to have more seizures, or more severe seizures. This could be harmful to you and your baby.
If you haven’t had advice about taking your medicine during pregnancy, talk to your doctor urgently. They should arrange for you to see a specialist to get the advice you need.
In some cases, your specialist may advise you to switch to another medicine. If so they should tell you how to do this safely.
For some women, valproate may be the only effective medicine for them. If this is the case for you, your specialist might advise you to keep taking it, even during pregnancy. They should arrange for you to see a specialist in fetal medicine. These are healthcare professionals who care for women whose babies are at higher risk of birth problems.
Can other epilepsy medicines harm my baby if taken during pregnancy?
Some other epilepsy medicines can put your baby at risk of birth defects if taken during pregnancy. But research shows the risk is lower than with valproate medicines. See our page about epilepsy medicines and pregnancy for more information.
Where can I find out more?
The Medicines and Healthcare products Regulatory Agency (MHRA) has produced a toolkit to make sure women are better informed about the risks of taking valproate medicines during pregnancy. It has also published a patient booklet for women taking valproate medicines.
If you would like to see this information with references, visit the Advice and Information references section of our website. If you are unable to access the internet, please contact our Epilepsy Action Helpline freephone on 0808 800 5050.
Epilepsy Action would like to thank Beth Irwin, epilepsy nurse/midwife, The Royal Hospital, Belfast, for her contribution to this information.
Beth Irwin has no conflict of interest to declare.
This information has been produced under the terms of The Information Standard.
- Updated May 2018To be reviewed May 2021