Topiramate (Topamax▼) pregnancy prevention programme and restrictions on use
Medicines containing topiramate, marketed under the brand name Topamax▼, are approved in Ireland to treat different types of epilepsy, either alone or with other medicines. Topiramate is also used in adults to prevent migraines after other possible treatment options have been considered.
Topiramate can harm an unborn child when taken during pregnancy. Children exposed during pregnancy have a higher risk for birth defects and may be smaller and weigh less than expected. They may also have a higher risk for autism spectrum disorders, intellectual disability, and attention deficit hyperactivity disorder.
Important contraindications, warnings, and risk minimisation measures are in place to prevent topiramate exposure during pregnancy.
Important information
If you are a patient treated with topiramate and have questions, speak with your doctor. Your doctor will explain what this means for you and any steps you may need to follow.
If you are taking topiramate for epilepsy, you should not stop taking it unless you have discussed it with your doctor first. This is because your epilepsy may become worse, which may also put you and your unborn child at risk.
Pregnancy prevention programme
In 2023, the EMAs safety committee (PRAC) recommended new measures to avoid topiramate exposure during pregnancy, including a pregnancy prevention programme.
The recommendations have been implemented in Ireland, and new materials to support the pregnancy prevention programme are available. These materials aim to support the safe prescribing and dispensing of topiramate and help ensure patients are fully informed of the risks of use during pregnancy and can discuss options with their doctors.
These materials should be used together with the approved product information for topiramate, which is accessible here.