New Pregnancy Prevention Measures Introduced for Topiramate

Following a major safety review triggered by a new study conducted in Europe, the Medicines and Healthcare products Regulatory Agency (MHRA) is introducing new safety measures for topiramate, also known by the brand name Topamax. 


Following recommendations made in the review, the MHRA is now advising healthcare professionals that topiramate should not be prescribed to treat epilepsy during pregnancy unless there is no suitable alternative treatment. Topiramate should already not be used during pregnancy for migraine because of the known link with an increased risk of birth defects.

In order to fulfil the conditions of a Pregnancy Prevention Programme, women of childbearing potential must use effective birth control throughout treatment and take a pregnancy test prior to starting topiramate.

Advice to patients include:


  • new measures are being introduced because there is evidence that taking topiramate during pregnancy can increase the risk to the baby of congenital malformation, low birth weight, intellectual disability, autistic spectrum disorder and attention deficit hyperactivity disorder
  • use effective birth control (contraception) at all times during your treatment with topiramate and for at least 4 weeks after the last dose
  • topiramate may interact with some hormonal contraceptives. Your General Practitioner (GP), specialist, sexual health and contraception clinic or contraception service in community pharmacy will discuss which method of birth control is best for you
  • if you are thinking about having a baby, make an appointment with your GP. Do not stop using topiramate and contraception before you have talked to your doctor
  • 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)
  • if you think you are pregnant and are taking topiramate for migraine prevention, stop taking topiramate straight away and contact your GP
  • it is important to visit your doctor to review your treatment at least once each year
  • always read the safety leaflet that comes with your medicine and consult the new Patient Guide for information about the risk of topiramate use during pregnancy


The full Drug Safety Update from MHRA can be found here.