Topiramate Pregnancy Prevention Programme
Topiramate (Topamax) is a medicine licensed in Ireland to treat epilepsy and migraine. If a women become pregnant while taking Topiramate, their baby is at an increased risk of neurodevelopmental impacts. Research in 2022 found that for children who were exposed to Topiramate monotherapy (i.e., no other ASM was used) during pregnancy, Autism Spectrum Disorder presented in 4.3% of cases, while Intellectual Disabilities presented in 3.1% of cases. The findings of this research triggered a review by the European Medicines Agency of the current safety measures attached to the medication. In October 2023, the introduction of a Pregnancy Prevention Programme was adopted by the Europeans Medicine Agency.
What is a pregnancy prevention programme (PPP)?
A PPP aims to put in place measures to ensure that the risk of exposure of babies to Topiramate in the womb are reduced – and that women on the medication are fully informed of the risks. The key points of the PPP from an epilepsy perspective are as follows:
- Topiramate must not be used in pregnancy for women with epilepsy unless there is no suitable alternative treatment.
- Topiramate must not be used in patients with epilepsy unless the conditions of the PPP are met
What are the key points of the Topiramate PPP?
The key points of the PPP were communicated to all Healthcare Professionals in correspondence from the Health Products Regulatory Authority in Oct 2023. The key points of this from an epilepsy perspective are outlined below; while the correspondence sent to Healthcare Professionals can be read and downloaded at the end of this page.
In female children and women of childbearing potential:
- Treatment with topiramate should be initiated and supervised by a physician experienced in the management of epilepsy
- Alternative therapeutic options should be considered.
- The need for topiramate treatment in these patients should be reassessed at least annually.
In women of childbearing potential
- Topiramate for epilepsy is contraindicated:
in pregnancy, unless there is no suitable alternative treatment;
in women of childbearing potential not using highly effective contraception. The only exception is a woman for whom there is no suitable alternative but who plans a pregnancy and who is fully informed about the risks of taking topiramate during pregnancy. - Pregnancy testing should be performed before initiating treatment.
- The patient must be fully informed and understand the potential risks related to the use of topiramate during pregnancy. This includes the need for a specialist consultation if the woman is planning a pregnancy and for prompt contact with a specialist if she becomes pregnant or thinks she may be pregnant.
- At least one highly effective method of contraception (such as an intrauterine device) or two complementary forms of contraception including a barrier method should be used during treatment and for at least 4 weeks after stopping treatment. Women using systemic hormonal contraceptives should be advised to also use a barrier method.
- If a woman is planning to become pregnant, efforts should be made to switch to an appropriate alternative epilepsy treatment before contraception is discontinued. For the treatment of epilepsy, the woman must also be informed about the risks of uncontrolled epilepsy to the pregnancy.
- If a woman being treated with topiramate for epilepsy becomes pregnant, she should promptly be referred to specialists to reassess topiramate treatment and consider alternative treatment options, as well as for careful antenatal monitoring and counselling.
In female children with epilepsy
- Prescribers must ensure that parent(s)/caregiver(s) of female children using topiramate understand the need to contact a specialist once the child experiences menarche.
- At that time, the patient and parent(s)/caregiver(s) should be provided with comprehensive information about the risks due to topiramate exposure in utero, and the need for using highly effective contraception.
Are there any patient information materials available?
A number of patient information materials have been produced to help alert patients and their healthcare professionals about the pregnancy prevention programme associated with Topiramate, These are listed below and are available for download at the end of this page. These are the the most up to date materials, published in May 2024.
- Topiramate Patient Guide
- Topiramate Healthcare Professional Guide
- Topiramate Annual Risk Acknowledgement Form
- Topiramate Pharamacy Flyer
- Topiramate Box Flyer
- Topiramate Pharmacy Shelf Box flyer
- Topiramate Patient Card
Further information
- It is important to note that there is a risk with all medications when taken during pregnancy, and pre-conceptual planning with your medical team is highly recommended in order to take tailored decisions that are best suited for you and your child. You can read more about this by visiting the ‘Pregnancy’ section of our website.
- Read the initial study which triggered this PPP by visiting the 'News' section of our website.
- Read the initial advice resulting from this study by visiting the 'News' section of our website.
- Read our article on the recommendation of a PPP by visiting the ‘News’ section of our website.
- Further information and advice on managing epilepsy as a woman can be found by visiting the 'Women' section of our website.
- Further information on the Topiramate Pregnancy Prevention Programme and associated materials can also be found by visiting the HPRA website.
- If you need information or support regarding your epilepsy, please contact your local Community Resource Officer. You can find their details by visiting the 'Our Local Service' section of our website.