(Date of issue: December 2014. Version: 2.1)
This factsheet has been written for members of the public by the UK Teratology Information Service (UKTIS). UKTIS is a not-for-profit organisation funded by Public Health England on behalf of UK Health Departments. UKTIS has been providing scientific information to health care providers since 1983 on the effects that medicines, recreational drugs and chemicals may have on the developing baby during pregnancy.
What is it?
Levetiracetam (Keppra®, Desitrend®) is used to treat epilepsy, sometimes in combination with other medicines.
Is it safe to take levetiracetam in pregnancy?
There is no yes or no answer to this question. When deciding whether or not to take levetiracetam during pregnancy it is important to weigh up how necessary levetiracetam is to your health against the possible risks to you or your baby, some of which will depend on how many weeks pregnant you are. Remaining well is particularly important during pregnancy and whilst caring for a baby. It is vital that epilepsy is well-controlled during pregnancy as seizures can harm both the mother and unborn child. For some pregnant women treatment with levetiracetam may be necessary.
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 bumps leaflet.
This leaflet summarises the scientific studies relating to the effects of levetiracetam on a baby in the womb. It is advisable to consider this information if you are taking levetiracetam and are pregnant or could become pregnant in the future.
Your doctor is the best person to help you decide what is right for you and your baby.
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, if so, to make sure that you are taking the lowest dose that works and only for as long as you need to.
It is very important that you do not suddenly stop taking levetiracetam as this could be dangerous to you, and also to your baby if you are already pregnant. Do not make any changes to your medication without first talking to your doctor.
Because of the normal bodily changes that occur as pregnancy progresses your doctor may advise closer monitoring of your health to assess whether your levetiracetam dose needs to be adjusted during your pregnancy for it to remain effective. You should not change the dose of any prescribed medicine without medical supervision.
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 1,300 babies born to women who took levetiracetam on its own during pregnancy have been studied in total. These babies do not appear to be any more likely to have a birth defect than babies born to women who didn’t take levetiracetam. While this is reassuring, studies that investigate all types of birth defect together in a single group are often unable to detect whether there is an increased chance of specific types of birth defect (especially uncommon ones).
To get around this problem one small study has investigated certain birth defects individually. This study did not shown any links between exposure to levetiracetam in early pregnancy and heart defects, cleft lip and palate (a split in the top lip and/or roof of the mouth), neural tube defects (e.g. spina bifida), and hypospadias in boys (where the opening of the penis is on the underside rather than the tip). However, additional larger studies need to be carried out before a link between levetiracetam use in pregnancy and any specific birth defect can be ruled out.
Levetiracetam in combination with other anti-epileptic medicines
Levetiracetam is sometimes taken in combination with other medicines to treat epilepsy. Some studies have suggested that in general women taking combinations of anti-epileptic medicines may be more likely to have a baby with a birth defect than women taking a single anti-epileptic medicine. However, it is now thought that this finding may be due to the fact that many of the women in these studies were taking combinations of anti-epileptics that included either sodium valproate (Epilim®) or carbamazepine (Carbagen®, Tegretol)®, both of which are known to cause birth defects.
Although some studies have shown that women taking levetiracetam in combination with other anti-epileptic medicines may be more likely to have a baby with a birth defect than women taking levetiracetam on its own, these studies mostly did not record the anti-epileptic drugs that the women were taking in addition to levetiracetam. It is therefore possible that the increased risk of birth defects was due to the other medicines and not to levetiracetam. More research into this subject is required to confirm this.
If you are taking more than one medicine to control epilepsy you should discuss any concerns that you may have with your doctor. Do not alter the dose of any medicine you are taking without first speaking to your doctor. Making changes to your medicine yourself may be more harmful to both you and your baby than continuing to take that medicine.
Can taking levetiracetam in pregnancy cause miscarriage or stillbirth?
A single study has investigated this and showed that rates of miscarriage and stillbirth in a small group of women who had taken levetiracetam in pregnancy were similar to the rates in the background population. However, more studies of these pregnancy outcomes are required to confirm these findings.
Can taking levetiracetam in pregnancy cause preterm birth or my baby to be small at birth (low birth weight)?
There is no known link between taking levetiracetam in pregnancy and preterm birth, but no scientific studies have specifically investigated this.
A side effect of levetiracetam in non-pregnant users is that it may cause weight loss. The one small study which assessed the possibility of an effect on a baby’s growth in the womb did not show that exposure to levetiracetam in the womb is linked to a baby being smaller than expected for the stage of pregnancy. However, until more research is done to confirm this finding, your doctor may recommend that your baby’s growth is monitored closely if you are pregnant and taking levetiracetam.
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 at any stage of pregnancy could have a lasting effect on a child’s learning or behaviour. Other anti-epileptic medicines have been shown to affect a baby’s brain development when taken in pregnancy.
A single study compared learning and behaviour between children who had been exposed to levetiracetam in the womb and children not exposed to levetiracetam. There were no differences in learning and behaviour when the children were first assessed before two years of age, or again at between three and four and a half years of age.
Although the results of this study are reassuring, because only small numbers of children have been studied, and only until early childhood, much more research is required before we can say whether exposure to levetiracetam in the womb can cause changes in learning and behaviour.
Will 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.
Up to 1 out of every 5 pregnancies ends in a miscarriage, and 1 in 40 babies are born with a birth defect. These are referred to as the background population risks. They describe the chance of these events happening for any pregnancy before taking factors such as the mother’s health during pregnancy, her lifestyle, medicines she takes and the genetic make up of her and the baby’s father into account.
Medicines use in pregnancy
Most medicines used by the mother will cross the placenta and reach the baby. Sometimes this may have beneficial effects for the baby. There are, however, some medicines that can harm a baby’s normal development. How a medicine affects a baby may depend on the stage of pregnancy when the medicine is taken. If you are on regular medication you should discuss these effects with your doctor/health care team before becoming pregnant.
If a new medicine is suggested for you during pregnancy, please ensure the doctor or health care professional treating you is aware of your pregnancy.
When deciding whether or not to use a medicine in pregnancy you need to weigh up how the medicine might improve your and/or your unborn baby’s health against any possible problems that the drug may cause. Our bumps leaflets are written to provide you with a summary of what is known about use of a specific medicine in pregnancy so that you can decide together with your health care provider what is best for you and your baby.
Every pregnancy is unique. The decision to start, stop, continue or change a prescribed medicine before or during pregnancy should be made in consultation with your health care provider. It is very helpful if you can record all your medication taken in pregnancy in your hand held maternity records.