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What is the Valproate Pregnancy Prevention Programme?
Valproate medicines can be an effective treatment for epilepsy. But research has shown that taking valproate medicines during pregnancy can seriously harm an unborn baby. Valproate medicines include sodium valproate (Epilim, Episenta, Epival, Depakote) and valproic acid (Convulex).
In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) has issued rules about how doctors can prescribe valproate medicines.
The rules say doctors must not prescribe valproate to women or girls of childbearing age, unless they are on the Valproate Pregnancy Prevention Programme. The programme aims to make sure that women taking valproate medicine are aware of the risks in pregnancy and are using highly effective contraception to avoid becoming pregnant.
Get medical advice before making changes to your epilepsy medicine
This could cause you to have more seizures or seizures that are more severe. This could be harmful for you and your baby. Instead, speak to your GP urgently, so they can get you the help and advice you need.
What problems can taking valproate medicines during pregnancy 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 10 in every 100 babies will be born with birth defects.This compares with 2 to 3 out of 100 in the general population.
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 30 and 40 in every 100 children have problems with learning and development. The long-term effects are not yet 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. These children are also more likely to develop symptoms of attention deficit hyperactivity disorder (ADHD).
Questions you may have
I’m taking valproate and want to get pregnant. What should I do?
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.
Having uncontrolled seizures can increase the risk of sudden unexpected death in epilepsy (SUDEP) for some people with epilepsy. As well as taking your epilepsy medication as prescribed, there are a number of other things you can do to reduce your risk of SUDEP.
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.
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.
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.
There are also certain epilepsy medicines which are safer to use in pregnancy as research suggests they do not increase the risk of birth defects. See our page about epilepsy medicines and pregnancy for more information.
I think my child has been affected by valproate medicines. What should I do?
If you are concerned that your child has been affected by use of valproate medicine during pregnancy, you can discuss this with your family doctor. The doctor may refer your child to see a specialist in children’s medicine if they think this is needed.
You could also contact a support network such as:
- Where can I find out more?
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