Topiramate

  • Procedure started
  • Under evaluation
  • PRAC recommendation
  • CMDh position
  • European Commission final decision

Table of contents

Current status
Under evaluation

Overview

PRAC starts review of topiramate use in pregnancy and women of childbearing potential

EMA’s safety committee (PRAC) has started a review of topiramate and the risk of neurodevelopmental disorders in children whose mothers were taking topiramate during pregnancy. Topiramate is a medicine used in the EU for the treatment of epilepsy, prevention of migraine and, in some countries, in combination with phentermine for body weight reduction.

Use of topiramate in pregnant women is known to increase the risk of birth defects. Women with epilepsy who are being treated with topiramate for their seizures are advised to avoid becoming pregnant, and to consult their doctor for advice if they wish to become pregnant. Topiramate must not be used to prevent migraine or control body weight in pregnant women and in women of childbearing potential (women able to have children) who are not using highly effective birth control methods (contraception).

The review was triggered by a recent study1 which suggested a possible increase in the risk of neurodevelopmental disorders, in particular autism spectrum disorders and intellectual disability, in children whose mothers were taking topiramate during pregnancy.   

The study was based on data from several Nordic registries (Denmark, Finland, Iceland, Norway and Sweden), and included information from more than 24,000 children exposed to at least one anti-epileptic medicine before birth. Of these children, 471 were exposed to topiramate alone, including 246 children born to mothers who had epilepsy.

The PRAC started reviewing the study results as part of a safety signal assessment in July 2022. The committee will now conduct an in-depth review of the available data on the benefits and risks of topiramate use in pregnant women and women of childbearing potential in the approved indications. The committee will look in particular at the current risk minimisation measures and consider the need for additional measures to minimise the risks of topiramate use in these women.

While the review is ongoing, topiramate should continue to be used according to the authorised product information. Women should discuss any questions or concerns about their topiramate treatment with their doctor or pharmacist. Patients should not stop antiepileptic treatment before speaking with their doctor.

Following this review, the PRAC will give its recommendation as to whether marketing authorisations of topiramate-containing products should be maintained, varied, suspended or revoked.

EMA will communicate the PRAC’s recommendation once the review has concluded.

1 Bjørk M, Zoega H, Leinonen MK, et al. Association of Prenatal Exposure to Antiseizure Medication With Risk of Autism and Intellectual Disability. JAMA Neurol. Published online May 31, 2022. doi:10.1001/jamaneurol.2022.1269.

Key facts

About this medicine
Approved name
Topiramate
International non-proprietary name (INN) or common name
topiramate
About this procedure
Current status
Under evaluation
Reference number
EMEA/H/A-31/1520
Type
Article 31 referrals

This type of referral is triggered when the interest of the Union is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.
Authorisation model
Nationally authorised product(s)
Decision making model
PRAC-CMDh
Key dates and outcomes
Procedure start date
01/09/2022

All documents

Procedure started

Description of documents published

Please note that some of the listed documents apply only to certain procedures.

  • Overview - lay-language summary of the stage of the procedure
  • Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
  • Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
  • List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
  • Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
  • List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
  • List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
  • Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
  • Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
  • Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
  • Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
  • Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
  • Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
  • Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
  • Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)

Note that older documents may have different titles.

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