Sodium valproate
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Valproate can cause birth defects and altered learning and behaviour in children who were exposed in the womb. These problems are sometimes called ‘fetal valproate spectrum disorder’.
Because of these risks, if you take valproate and could get pregnant, your doctor should have enrolled you on a ‘pregnancy prevention programme’. This involves using very reliable contraception and having a negative pregnancy test every time your valproate is prescribed.
If you are planning a pregnancy and take valproate, before stopping contraception you should arrange to see your specialist to discuss whether you can change your medicine. Valproate should only ever be used in pregnancy if your specialist advises that no other medicine will work to treat your medical condition.
What is it?
Valproate (Sodium valproate - Depakin®, Dyzantil®, Epilim®, Episenta®, Epival® and Valproic acid – Belvo®, Depakote®, Syonell®, Convulex®) is a medicine to treat epilepsy and bipolar disorder and to prevent migraine.
Benefits
What are the benefits of taking valproate in pregnancy?
Valproate will only be offered in pregnancy if there is no safer medicine to control your epilepsy. Women with bipolar disorder will usually be switched to another medicine. Both of these conditions require very effective treatment as they can be life-threatening and can also lead to pregnancy complications.
Valproate should not be used to prevent migraine during pregnancy as there are alternatives that are safer for your baby.
Risks
Are there any risks of taking valproate during pregnancy?
Yes. Up to one in every 10 babies exposed in the womb to valproate in the first trimester will have a physical birth defect such as a heart defect, spina bifida, or cleft lip and palate. Some affected children have altered facial features.
Studies have also shown that children who were exposed to valproate in the womb at any stage of pregnancy have a higher chance of autism spectrum disorder (ASD), problems with motor development (movement), and intellectual disability. The risk of attention deficit hyperactivity disorder (ADHD) might also be increased. Children who were exposed to valproate are more likely to need support at school. Some children with learning and behavioural differences caused by valproate do not have any obvious physical birth defects.
Valproate use during pregnancy might also be linked to an increased chance of your baby having a low birth weight, and a single study has shown that doses over 750mg a day might increase the risk of miscarriage.
There is no known safe dose of valproate during pregnancy, but, in general, higher doses are linked to a greater chance of problems in the baby. Studies have shown that doses of valproate over 1000mg per day are linked to the highest risk of birth defects and learning and behavioural problems.
Valproate can affect folic acid levels. Folic acid is required for a baby to develop normally in the womb. UK guidelines state that women taking valproate while trying to conceive and during pregnancy should be prescribed a high dose folic acid supplement (5mg/day). However, it is still not clear whether folic acid at any dose can protect against the harmful effects valproate can have on an unborn child.
More information about the risks of valproate use during pregnancy is available here.
Alternatives
Are there any alternatives to taking valproate?
Possibly. If you are planning a pregnancy, it is important to request a medication review with your specialist to see if you can change your medicine. Some women might be offered two or more different medicines at the same time to replace valproate. Your specialist will help you to weigh up the risks and benefits to both you and your baby of different types of treatment.
Valproate is only prescribed in pregnancy if your epilepsy cannot be controlled with a different drug.
If you take valproate to treat bipolar disorder or prevent migraines, you should speak to your doctor who should be able to prescribe a different medicine while you are pregnant.
If you have an unplanned pregnancy while taking valproate, you should be reviewed as soon as possible by your GP or specialist.
No treatment
What if I prefer not to take medicines during pregnancy?
It is important to take any medicines prescribed to treat epilepsy or bipolar disorder as you may become very unwell if these conditions are not well-controlled.
Your doctor will only prescribe medicines when necessary and will be happy to talk about any concerns that you might have.
Please do not stop or reduce your dose of valproate unless this has been advised by your GP or specialist.
Will I or my baby need any extra monitoring?
All pregnant women in the UK will be offered a very detailed anomaly scan, usually at around 20 weeks of pregnancy, as part of their routine antenatal care. If you take valproate in the first trimester you might be offered this anomaly scan from around 16 weeks onwards. It is important to note that not all the problems that valproate can cause in the baby can be detected by an ultrasound scan.
The changes to your body that occur as pregnancy progresses mean that your dose of valproate may need to be adjusted. You will be offered regular monitoring, particularly in later pregnancy, to ensure that your symptoms remain well-controlled.
Babies exposed in the womb to valproate will be checked at birth and will be monitored for a while afterwards in case they have withdrawal symptoms.
Are there any risks to my baby if the father has taken valproate?
Valproate use can affect male fertility. This doesn’t happen to everyone and usually returns to normal once the drug is stopped. If you are experiencing problems getting pregnant and your male partner uses valproate, speak to your GP who might advise tests to check sperm.
Studies do not indicate that use of valproate in men around the time of conception increases the risk of birth defects in the baby.
Overall, there is no good evidence that valproate use in men around the time of conception can cause learning and behavioural problems in children. However, as a precaution, men who are planning to father a pregnancy should request a medication review to make sure that valproate is still the best choice of medication.
Who can I talk to if I have questions?
If you have any questions regarding the information in this leaflet, please discuss them with your health care provider. They can access more detailed medical and scientific information from www.uktis.org.