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.

Do not stop taking your medicine before speaking to your doctor

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.

• A Patient Guide which should be provided to all girls, parent(s)/caregiver(s) and women of childbearing potential treated with topiramate.

• A Guide for Healthcare Professionals involved in the care of girls and women of childbearing potential treated with topiramate.

• An Annual Risk Awareness Form, intended to facilitate discussion of the risks related to the use of topiramate when treatment is first started, at the annual visit or when pregnancy is planned.

• A patient card, attached to the packaging.

• A visual warning on the packaging to inform healthcare professionals and patients about the risks to an unborn child if used during pregnancy.

• Pharmacy materials (poster and shelf barker) to assist pharmacists in dispensing and advising patients taking topiramate.

• A Direct Healthcare Professional Communication (DHPC) outlining the pregnancy prevention programme.

These materials should be used together with the approved product information for topiramate.

Reporting suspected side effects to the HPRA

Topiramate-containing medicines are subject to additional monitoring requirements. Any medicine subject to additional monitoring in the EU is identifiable by an inverted black triangle after the medicine's name ▼. Healthcare professionals and members of the public are requested to report any suspected adverse reactions associated with their use via the  HPRA reporting forms.

Product information for topiramate-containing medicines

The product information is comprised of the Summary of Product Characteristics (SmPC) and Package Leaflet (PL). These documents are issued when a medicine is first licensed for use and are reviewed and updated as necessary throughout the lifetime of a medicine. The SmPC is mainly intended for use by healthcare professionals and includes detailed information on the use, dosing recommendations, precautions for use and the known side-effects of the medicine concerned. SmPCs for products currently authorised in Ireland are accessible from the HPRA's Find a Medicine function. The package leaflet (PL) reflects the more comprehensive information described in the SmPC but is required to be presented in a shortened and easy-to-read format for patients. The PL should be included in your box of medicine received from your pharmacist.

The approved product information for topiramate includes detailed warnings and recommendations for healthcare professionals and patients regarding the use of this medicine. This includes the need for treatment to be started and supervised by a specialist experienced in the management of epilepsy or bipolar disorder. Copies of the current versions of the product information are available from the HPRA website, by searching for 'topiramate' or 'Topamax' in the Find a Medicine search box.

HPRA-approved communications for healthcare professionals

The HPRA communications, listed below, include Direct Healthcare Professional Communications (DHPCs) and articles in the HPRA Drug Safety Newsletter. In addition, the HPRA provided articles which were published in MIMS (Ireland) and the Irish Medicines Formulary (IMF). All communications are published on the HPRA website and are linked below.

Learn more about the EU-wide review of topiramate on the EMA website.

2024

2023

2022