Safety review to begin on topiramate

Topiramate is used for the treatment of epilepsy and migraine. It is used specifically:

• to prevent migraine headaches in adults after consideration of possible other treatments
• alone to treat seizures in adults and children older than age 6 years
• with other medicines to treat seizures in adults and children aged 2 years and above

It should only be prescribed under the supervision of a healthcare professional.

Topiramate is already known to harm the way an unborn baby grows and develops if it is used during pregnancy. Therefore, women should already be advised to use highly effective birth control while on topiramate and to avoid becoming pregnant while using this medicine.

There are other treatments for use in pregnancy that are safer for the baby such as lamotrigine and levetiracetam. Information shows that these medicines do not increase the risk of physical birth abnormalities compared with the general population.

A safety review is today being initiated into topiramate following an observational study suggesting a potential increased risk of neurodevelopmental disabilities (including autism spectrum disorder and effects on learning and development) in children exposed to topiramate during pregnancy.

Women on topiramate who are planning a pregnancy should speak to their doctor about other treatment options, but they should not stop taking topiramate without first discussing it with a healthcare professional.

Topiramate is available as tablets, a liquid oral solution, or as capsules that can be swallowed whole or sprinkled on soft food. The brand name of topiramate is Topamax.

Previous reviews of topiramate and harms in pregnancy

Following a review by the Commission on Human Medicines into the safety of antiepileptic drugs in pregnancy, including topiramate, in January 2021 we published new safety advice in Drug Safety Update with patient advice, and a Public Assessment Report.

Topiramate use in pregnancy is linked to an increased risk of birth defects and an increased risk of the baby being born of low birth weight and small for gestational age (fetal growth restriction).

Scope of this review

The Medicines and Healthcare products Regulatory Agency (MHRA) routinely undertakes reviews of the safety of medicines, seeking independent expert advice from the Commission on Human Medicines. The MHRA is responsible for the safety, efficacy and quality of medicines and so this safety review focuses on the regulatory position in the UK.

The scope of the review is:

1. To evaluate information from all Marketing Authorisation Holders and available sources, including relevant stakeholders (patients, patient representatives, healthcare professionals, healthcare organisations, researchers, charity and patient organisations) on the possible harms associated with the use of topiramate during pregnancy.
2. To consider whether further regulatory action is required to minimise risk and ensure awareness of the risks.
3. To consider the impact of the available information considered as part of this review on the balance of benefits and risks of topiramate.
4. To consider what research could be undertaken to further elucidate the long-term impact on children of exposure to topiramate during pregnancy.
5. To make recommendations to the Commission on Human Medicines to improve the balance of benefits and risks for topiramate, to raise awareness of the associated risks and for further research to evaluate the risks.

Following completion of this safety review, a report of the CHM's conclusions and recommendations will be published on this website and will also be sent to those who have indicated that they would like to receive notifications.

Timeframes for the review

After the CHM has considered the review, the MHRA will take forward the recommendations and update the timelines for the review where necessary.

If you would like to receive notifications in relation to this safety review please contact