Bottle of topiramate medication

New topiramate safety measures and pregnancy

Topiramate, also known by the brand name Topamax, is an anti-seizure medication. Doctors should no longer prescribe topiramate to treat epilepsy during pregnancy unless there is no suitable alternative treatment. Girls and women whose periods have started will need to take steps to avoid pregnancy if they take topiramate.

Why was this new safety measure introduced?

It was introduced by the MHRA (Medicines and Healthcare products Regulatory Agency) in June 2024 following a major safety review.

The review was carried out by the Commission on Human Medicines (CHM) and looked at the risks linked with taking topiramate during pregnancy. It showed that women who take topiramate during their pregnancy have a higher risk of having a baby with birth defects, low birth weight, learning disability, autism and attention deficit hyperactivity disorder (ADHD).

What you need to know if you take topiramate as anti-seizure medication

This information is for women and girls or their parents.

If your periods haven’t started yet 

  • You should know about the risks of using topiramate during pregnancy. 
  • If you are taking topiramate, as soon as you have your first period: 
    • you should contact your epilepsy doctor 
    • your doctor will decide with you whether topiramate is still the right medicine for you. They will look at the risks and other treatment options. They may change your medicine to one with a lower risk to a baby. 
    • your doctor may ask you to do a pregnancy test, because you must not take topiramate if you are pregnant.

If your periods have already started 

  • If you are starting treatment with topiramate your epilepsy doctor will discuss the benefits and risks of topiramate with you (and your parents) and explain why they think topiramate is the right medicine for you. You will need to complete an Annual Risk Awareness Form to make sure you’re aware of the risks of using topiramate during pregnancy and the need to avoid becoming pregnant whilst taking topiramate.
  • Always use effective birth control (contraception) during your treatment with topiramate and for at least 4 weeks after the last dose. If there is a clear reason that you’re not at risk of becoming pregnant then you may not need to use birth control (contraception). This joint decision should be written down in your Annual Risk Awareness Form.
  • Topiramate may affect some hormonal birth control (contraceptives). Speak to your GP, specialist, sexual health and contraception clinic or pharmacy contraception service about which method of birth control is best for you.
  • If you are thinking about having a baby, do not stop using topiramate or birth control (contraception) before you have talked to your doctor. Make an appointment with your GP to talk about your treatment options. Safer options for anti-seizure medication that can be used during pregnancy include lamotrigine and levetiracetam.  
  • If you think you are pregnant and are taking topiramate for epilepsy, do not stop using topiramate. This may cause your seizures to start again, happen more often or last longer. Make an urgent appointment with your GP or epilepsy team (within a few days).
  • Visit your doctor to review your treatment at least once a year. At each annual review your epilepsy doctor will discuss the benefits and risks of topiramate with you (and your parents) and you will need to complete an Annual Risk Awareness Form. They may discuss switching you to another medication.

Always read the safety leaflet that comes with your medicine.

Check the new Patient Guide for Epilepsy, about the risk of using topiramate during pregnancy.

If you are worried about the risks of topiramate, talk to your doctor, nurse, specialist or pharmacist.

Find out more on the MHRA website