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Are there risks to my baby

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Are there risks to my baby?

Most women with epilepsy will have a normal pregnancy and labour and over a 9 in 10 (90%) chance of having a healthy baby. Women with epilepsy have a slightly higher chance of having a baby with a birth abnormality due to genetic conditions, injury during seizures and anti-seizure medications (ASMs). Talk to your neurologist about how you can reduce the risk to your unborn baby.

Minor and major malformations

For any pregnant woman there is a small risk (a ‘background’ risk) that her baby may be born with a birth abnormality or malformation. Physical birth abnormalities are problems that happen when the development of a baby is affected while it is in the womb. There are different types of birth abnormalities which can affect different organs in the body, and can happen for different reasons. Sometimes birth abnormalities are classed as 'minor' and 'major'.

Minor malformations are those that do not need surgery, for example small fingers and toes, and eyes set wide apart.

Major malformations are those that need surgery to correct them. These include a hole in the heart, problems with the kidneys or genitals, cleft lip and cleft palate (where the roof of the mouth is not correctly joined). They also include problems with the development of the spine and nervous system (neural tube defects), such as spina bifida (where part of the spinal cord is exposed). Sometimes the child’s arms, legs, or the way their face looks, may also be affected.

If you are pregnant, avoiding the following will all help reduce the risk of birth abnormalities: alcohol, smoking, unprescribed medication and illegal drugs. This is because all these substances can be passed through your bloodstream to your baby and so may affect the baby's development. Women with epilepsy have a slightly higher chance of having a baby with a birth abnormality than women who don't have epilepsy. This may be due to an underlying genetic condition which also caused the epilepsy. Or risks can be due to injury to your unborn baby if you have seizures during pregnancy.        

ASMs and birth abnormalities

Women with epilepsy who take anti-seizure medications (ASMs) during pregnancy also have a slightly higher risk than women with epilepsy who don't take ASMs. Different ASMs vary in the risk they pose, and the risk of birth abnormalities rises with higher doses of the drug, and if you already have a child with a birth abnormality. Taking more than one ASMD increases the risks, especially if this includes sodium valproate.

  • 2 – 3 women in every 100 (2 – 3%) in the general population will have a baby with a major malformation (the 'background risk').
  • 3 women in every 100 (3%) who have epilepsy and don’t take ASMs will have a baby with a major malformation.
  • 4 – 10 women in every 100 (4 – 10%) who have epilepsy and do take an ASM will have a baby with a major malformation.

Taking more than one ASM increases the risks, especially if this includes sodium valproate (see below).

Recent studies carried out by the Commission on Human Medicines (CHM), looking at the risks associated with commonly prescribed ASMs shows that lamotrigine (Lamictal) and levetiracetam (Keppra) are safer to use during pregnancy than other ASMs, having low rates of physical birth abnormalities, in line with the background risk (2 - 3%). Again, for each drug the risks increase with higher doses. The Medicines and Healthcare Products Regulatory Agency (MHRA) has produced more guidance on the risks for ASMs in pregnancy. A further study into Pregabalin was published in April 2022.

Sodium valproate – an important case

Sodium valproate (brand names include Epilim, Episenta and Epival) has greater risks in pregnancy than other ASMs, with 7 women in 100 (7%) having a baby with a major malformation, rising to 1 in 10 women (10%) if they take more than 1000mg (1g) per day.

Also, up to 4 children in 10 (up to 40%) whose mothers took sodium valproate have problems with development and learning.

The MHRA states that sodium valproate should not be prescribed to girls or women who are pregnant, or who may become pregnant in future, unless it is the only effective drug for them and they are on a pregnancy prevention programme (PPP).

They also recommend that treatment with sodium valproate should only be started by a doctor experienced in managing epilepsy.

If you are taking sodium valproate, do not suddenly stop taking it, but talk to your doctor as soon as possible about the best treatment options for you. Sodium valproate is an effective drug for epilepsy and for some women, it is the best or only drug that controls their seizures.

Fetal anti-convulsant syndrome

Some ASMs are thought to affect a child’s development after they are born. This is called fetal anti-convulsant syndrome (FACS). The risk of this happening appears to be higher with sodium valproate than with other ASMs. 

Problems with the child's development and learning can include: delayed walking and talking, poor speech and language, and problems with memory, attention, lower intelligence and behaviour. Often these effects are not seen until the child starts to get older, for example when they start nursery or school. 

Children exposed to sodium valproate in the womb may also be more likely to have an autism spectrum disorder. There are organisations which provide information and support to families affected by fetal anti-convulsant syndrome

Information updated: April 2022

Sodium valproate

Sodium valproate is an epilepsy drug prescribed for all seizure types including absence, myoclonus and tonic clonic seizures. New regulations have been introduced by the Medicines and Healthcare products Regulatory Agency (MHRA) around the way in which the drug, sodium valproate is prescribed to women and girls of childbearing age. 

Medicines and Healthcare Products Regulatory Agency logo

Information from the Medicines and Healthcare Products Regulatory Agency

Read information produced by the MHRA around sodium valproate. 

Want to know more?

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Valproate organisations

The following groups have been set up by patients to help women who have children affected by valproate during pregnancy:

FACS-aware - 07739 411 373
FACS Association - 01253 799 161
OACS - 07904 200 364