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
- 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
Review of harms of topiramate use during pregnancy
Topiramate is indicated for the prophylaxis of migraine and for the treatment of epilepsy. It is available as tablets, a liquid oral solution and as capsules that can be swallowed whole or sprinkled on soft food. The brand name of topiramate is Topamax, and so this may also appear on the box. Topiramate has been contraindicated in pregnancy for the prophylaxis of migraine since 2010.
Excerpt from the official page. The original is authoritative. Continue reading at UK Drug Safety Update ↗