Topiramate (Topamax): introduction of new safety measures, including a Pregnancy Prevention Programme (MHRA, 20 June 2024)

Summary

Topiramate is now contraindicated in pregnancy and in women of childbearing potential unless the conditions of a Pregnancy Prevention Programme are fulfilled. This follows a review by the MHRA which concluded that the use of topiramate during pregnancy is associated with significant harm to the unborn child. Harms included a higher risk of congenital malformation, low birth weight and a potential increased risk of intellectual disability, autistic spectrum disorder and attention deficit hyperactivity disorder in children of mothers taking topiramate during pregnancy.

Content

General advice for healthcare professionals:

Topiramate should not be used:

• in pregnancy for prophylaxis of migraine
• in pregnancy for epilepsy unless there is no other suitable treatment.

Topiramate should not be used in women of childbearing potential unless the conditions of the Pregnancy Prevention Programme are fulfilled. This aims to ensure that all women of childbearing potential:

• are using highly effective contraception
• have a pregnancy test to exclude pregnancy before starting topiramate
• are aware of the risks from use of topiramate
• please see specific advice for prescribers and advice for dispensers
• ensure women of childbearing potential sign the Risk Awareness Form, you will receive materials including the Risk Awareness Form by post in the coming weeks to use in the implementation of the Pregnancy Prevention Programme
• report suspected adverse drug reactions associated with topiramate to the Yellow Card scheme.

Advice for healthcare professionals to provide to patients:

• 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.