Topiramate (Topamax): introduction of new safety measures, including a Pregnancy Prevention Programme

Topiramate is a drug used to treat migraine and epilepsy. The brand name of topiramate is Topamax.

In January 2021, new safety advice was published following a comprehensive review of the safety of antiseizure medications in pregnancy, including Topiramate. New study data has since become available and in June 2024, a national alert was issued introducing new safety measures to make the use of Topiramate as safe as possible. The aim is to eliminate the harm Topiramate can cause to a baby exposed to the drug in pregnancy, whilst providing the best possible personalised care for patients with conditions treated with Topiramate.

Information for patients

Topiramate for epilepsy

if you think you are pregnant and are taking topiramate for epilepsy, do not stop using topiramate. This may cause your seizures to start again or happen more often and last longer. Make an urgent appointment with your GP or epilepsy team (within a few days)

Topiramate for migraine

If you think you are pregnant and are taking topiramate for migraine prevention, stop taking topiramate straight away and contact your GP or healthcare professional.

Information for clinicians and staff

The Medicines and Healthcare Products Regulatory Agency (MHRA) patient safety measures state that the use of topiramate is now contraindicated:

  • in women of childbearing potential unless the conditions of the Pregnancy Prevention Programme are fulfilled (for all indications)
  • in pregnancy for prophylaxis of migraine
  • in pregnancy for epilepsy unless there is no other suitable treatment

Further information can be found on GOV.UK.

Approach

The ICB needs to ensure there is a co-ordinated approach across Cheshire and Merseyside to implement these measures.

A Steering Group has been developed with representation from across primary and secondary care.  This group is led by Professor Marson, Professor of Neurology at the Walton Centre. Task and Finish groups have also been established to support the data, digital, and prescribing workstreams.