Date: December 2019, Version 3.1

What is it?

Levetiracetam (Keppra®, Desitrend®) is used to treat epilepsy, sometimes in combination with other medicines.
When deciding whether to use levetiracetam during pregnancy it is important to weigh up the potential benefits to your health and wellbeing against any possible risks to you or your baby, some of which may depend on how many weeks pregnant you are. Use of levetiracetam in pregnancy may sometimes be considered necessary to control epilepsy. Your doctor or specialist will help you make decisions about your treatment.
It is recommended that all women taking anti-epileptic medicines also take high dose folic acid (5mg/day) whilst trying to conceive and during the first trimester of pregnancy. High dose folic acid has to be prescribed by a doctor. For more information please see the folic acid bump leaflet.

What if I have already taken levetiracetam during pregnancy?

If you have taken or are taking any medicines it is always a good idea to let your doctor know that you are pregnant so that you can decide together whether you still need the medicines that you are on and to make sure that you are taking the lowest dose that works and only for as long as you need to.

If you have epilepsy it is very important that you do not suddenly stop taking levetiracetam as this could be dangerous. Do not make any changes to your medication without first talking to your doctor.

Because of the normal bodily changes associated with a progressing pregnancy, the dose of levetiracetam may need to be adjusted to ensure that symptoms remain well-controlled. Your doctor may offer ongoing monitoring to determine whether dose changes are required.

Can taking levetiracetam in pregnancy cause birth defects in the baby?

A baby’s body and most internal organs are formed during the first 12 weeks of pregnancy. It is mainly during this time that some medicines are known to cause birth defects.

Around 2,500 babies exposed to levetiracetam during pregnancy have been studied in total and, overall, there is no concern of a link with birth defects.

Can taking levetiracetam in pregnancy cause miscarriage or stillbirth?

The likelihood of miscarriage and stillbirth has been studied in only relatively small numbers of women taking levetiracetam. Whilst no concerns of any links have been raised, ongoing research is ideally required to confirm this.

Can taking levetiracetam in pregnancy cause preterm birth or my baby to be small at birth (low birth weight)?

One small study found no evidence of a link between taking levetiracetam in pregnancy and preterm birth, but further research is required to confirm this.

A side effect of levetiracetam in non-pregnant users is that it may cause weight loss. Around 220 babies exposed in the womb to levetiracetam have had their birth weights assessed, with no evidence of an effect on growth in the womb. However, until more research is done to confirm this finding, women who are pregnant and taking levetiracetam may be offered closer monitoring of their baby’s growth.

Can taking levetiracetam in pregnancy cause other health problems in the child?

Withdrawal symptoms at birth (neonatal withdrawal)
Withdrawal symptoms are thought to occur when a newborn baby’s body has to adapt to no longer getting certain types of medicines through the placenta.

Levetiracetam works in a similar way to other medicines that are known to cause neonatal withdrawal and close monitoring of your baby for a few days after birth may therefore be advised if you have taken levetiracetam regularly in the weeks before delivery. Monitoring of your baby may be particularly important if you have taken levetiracetam in combination with other anti-epileptic medicines or medicines that act on the brain.

Learning and behavioural problems
A baby’s brain continues to develop right up until the end of pregnancy. It is therefore possible that taking certain medicines (particularly those that act upon the brain) at any stage of pregnancy could have a lasting effect on a child’s learning or behaviour.

The learning and behaviour of around 200 children who were exposed in the womb to levetiracetam has been assessed, with no strong evidence of adverse effects. Although this is reassuring, much more research is required before we can say whether exposure to levetiracetam in the womb can cause changes in learning and behaviour.

Will I or my baby need extra monitoring?

Most women will be offered a scan at around 20 weeks of pregnancy to look for birth defects as part of their routine antenatal care. Pregnant women taking levetiracetam do not generally need extra scans for birth defects but may receive additional monitoring of their baby’s growth. Additionally, women with epilepsy may be more closely monitored during pregnancy to ensure that they remain well throughout and that their baby is growing and developing as expected. 

If you have taken levetiracetam around the time of delivery your baby may require extra monitoring after birth because of the risk of neonatal withdrawal.

Are there any risks to my baby if the father has taken levetiracetam?

We would not expect any increased risk to your baby if the father took levetiracetam before or around the time you became pregnant.

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

How can I help to improve drug safety information for pregnant women in the future?

Our online reporting system (MyBump Portal) allows women who are currently pregnant to create a secure record of their pregnancy, collected through a series of questionnaires. You will be asked to enter information about your health, whether or not you take any medicines, your pregnancy outcome and your child's development. You can update your details at any time during pregnancy or afterwards. This information will help us better understand how medicines affect the health of pregnant women and their babies. Please visit the MyBump Portal to register.

General information
Sadly, miscarriage and birth defects can occur in any pregnancy.

Miscarriage occurs in about 1 in every 5 pregnancies, and 1 in every 40 babies are born with a birth defect. This is called the ‘background risk’ and happens whether medication is taken or not.

Most medicines cross the placenta and reach the baby. For many medications this is not a problem. However, some medicines can affect a baby’s growth and development.

If you take regular medication and are planning to conceive, you should discuss whether your medicine is safe to continue with your doctor/health care team before becoming pregnant. If you have an unplanned pregnancy while taking a medicine, you should tell your doctor as soon as possible.

If a new medicine is suggested for you during pregnancy, please make sure that the person prescribing it knows that you are pregnant. If you have any concerns about a medicine, you can check with your doctor, midwife or pharmacist.

Our Bumps information leaflets provide information about the effects of medicines in pregnancy so that you can decide, together with your healthcare provider, what is best for you and your baby.