Topiramate

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Date: July 2024, Version 5

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Topiramate use in pregnancy has been linked to birth defects and lower birth weight in the baby, as well as altered learning and behaviour in children who were exposed in the womb.

Topiramate is occasionally used in pregnancy if no other medicine will work to treat epilepsy. 

What is it?

Topiramate (Topamax®) is a medicine used to treat epilepsy and to prevent migraine.

Benefits

What are the benefits of taking topiramate in pregnancy?

Topiramate prevents seizures, which can be dangerous or even life-threatening and can also lead to pregnancy complications. It is only used in pregnancy when other anti-seizure medications are not suitable.

Topiramate is not usually used to prevent migraine attacks during pregnancy as there are alternatives that are considered to be safer for the baby.

Risks

Are there any risks of taking topiramate during pregnancy?

Some studies have suggested that there is an increased chance of cleft lip and palate in the baby following use of topiramate in early pregnancy. Overall, it is very clear that most babies exposed to topiramate in the womb do not have cleft lip and palate. 
Topiramate use in pregnancy has been linked to lower birth weight in the baby.

Studies have also shown that children who were exposed to topiramate in the womb have a higher chance of autism spectrum disorder (ASD), attention deficit hyperactivity disorder (ADHD), and intellectual disability.

Because of these possible risks, women of childbearing potential who take topiramate should be enrolled on a ‘pregnancy prevention programme’. This involves pregnancy tests when prescriptions are issued and the use of reliable contraception.

Drugs used to treat epilepsy can affect folic acid levels. UK guidelines state that women taking anti-seizure medications while trying to conceive and during pregnancy should be prescribed a high dose folic acid supplement (5mg/day).

Alternatives

Are there any alternatives to taking topiramate?

Topiramate is generally only prescribed in pregnancy when epilepsy cannot be controlled with a different drug. In these cases, a specialist will help you to weigh up the risk from uncontrolled seizures to both you and your baby compared to the risk from drug exposure.

Women planning a pregnancy should be offered a medication review with their epilepsy specialist to determine whether topiramate is still the most suitable medicine. 

If you take topiramate to help prevent migraines, you should speak to your doctor who will be able to prescribe a different medicine while you are pregnant.  

Women with an unplanned pregnancy while taking topiramate should be reviewed as soon as possible by their GP or specialist.

No treatment

What if I prefer not to take medicines during pregnancy?

It is very important to take any medicines prescribed to treat epilepsy. Uncontrolled seizures can be serious and can lead to pregnancy complications.

Doctors will only prescribe medicines when absolutely necessary and will be happy to talk about any concerns that you might have. 

Pregnant women should not stop or reduce the dose of topiramate unless this has been advised by their GP or specialist.

Will my baby need extra monitoring?

All pregnant women in the UK will be offered a very detailed anomaly scan at around 20 weeks of pregnancy as part of their routine antenatal care. No extra monitoring for major birth defects is required following topiramate use in pregnancy. 

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

We would not expect any increased risk to your baby if the father takes topiramate.

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.

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