New patient information guides have been published containing important information on the anti-seizure medications Sodium Valproate (Epilim) and Topiramate (Topamax).
The guides have been approved by the Health Products Regulatory Authority (HPRA). They contain new information on the reproductive risks associated with the medications and the latest safety measures that have been put in place.
If you are taking either of these medications, please read the information below and download the patient guide.
I am a female taking Sodium Valproate (Epilim)
The guide for women and girls taking Sodium Valproate is an updated information leaflet on the PREVENT Pregnancy Prevention Programme which was introduced in 2018.
It contains key information about the risks of valproate use during pregnancy and the need for effective contraception. It is important that you read the leaflet even if you have been taking valproate for a while.
Around 11 babies in every 100 born to women who take valproate while pregnant will have a birth defect. This is compared to 2-3 babies in every 100 in the general population. In addition, 30-40% of pre-school children may experience neurodevelopmental disabilities.
- Download the new guide for women girls taking sodium valproate on our website
- Visit the 'Valproate' section to read further information on Sodium Valproate
I am a male taking Sodium Valproate (Epilim)
The guide for males taking Sodium Valproate is a new guide and is part of the recently introduced precautionary measures which are being taken for male patients on the medication.
A study from 2022 suggested that there may be an increased risk of neurodevelopmental disorders in children born to men being treated with valproate in the 3 months before conception. In this study, around 5 children in every 100 had such disorders when born to fathers treated with valproate, compared to around 3 children in every 100 when born to fathers treated with lamotrigine or levetiracetam (two other anti-seizure medicines).
Although it is not entirely clear if the increased risks are caused by valproate, the European Medicines Agency has recommended a series of precautionary measures which are explained in the new guide.
- Download the male patient guide on our website
- Read further information on the introduction of the male patient guide by visiting the 'News' section of our website.
I am a female taking Topiramate (Topamax)
The guide for women and girls taking Topiramate is a new guide and is part of the recently introduced (October 2023) pregnancy prevention programme associated with the medication.
It contains key information about the risks of topiramate use during pregnancy and the need for effective contraception.
Research has shown that children born to mothers who take topiramate during pregnancy are:
- 3 times more likely to have certain birth defects.
- More likely to be smaller and to weigh less than expected.
- 2 to 3 times more likely to develop autism spectrum disorders, intellectual disabilities, or ADHD compared to the general population.
Because of these risks, the European Medicines Agency recommended a range of new measures to promote patient safety, including a new pregnancy prevention programme. The measures are explained in the guide.
- Download the new guide for women/girls taking Topiramate on our website
- Visit the 'Topiramate' section of our website to read further information on Topiramate
Should you have any concerns, please discuss this with your healthcare professionals as soon as possible. DO NOT STOP TAKING THE MEDICATION WITHOUT FIRST CONSULTING WITH YOUR MEDICAL TEAM. If you are not currently attending specialist services, please contact your GP for advice and guidance in order to schedule a specialist review.
Your local Epilepsy Ireland Community Resource Officer is also available if you have any queries on these developments. You can find their details by visiting the ‘Our Local Services’ section of our website.