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Pregnancy Prevention Programme for Topiramate officially approved by European Medicines Agency

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Pregnant Women

We can confirm that the recommendation of a Pregnancy Prevention Programme (PP) for the Anti-Seizure Medication Topiramate has now been formally approved by the European Medicines Agency. 

The recommendation of the PPP came from the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC)  - following their assessment of research which found that the risk of neurodevelopmental impacts associated with the medication if prescribed during pregnancy was more significant than previously thought. 

The introduction of the PPP aims to ensure that women do not become pregnant while on the drug. With the formal adoption of the PPP by the EMA, the Health Products Regulatory Authority have now written to all Irish Healthcare professionals to begin the implementation of the programme in Ireland. 

This correspondence is available to read and download at the end of this article - while you can also read more on the EMA's formal adoption of the PPP by visiting the 'European Medicines Agency' website.

While Topiramate is also used to treat migraine, we have outlined the key points of the PPP from an epilepsy perspective below.

In female children and women of childbearing potential

  • Treatment with topiramate should be initiated and supervised by a physician experienced in the management of epilepsy
  • Alternative therapeutic options should be considered.
  • The need for topiramate treatment in these patients should be reassessed at least annually.

In women of childbearing potential

  • Topiramate for epilepsy is contraindicated:
     in pregnancy, unless there is no suitable alternative treatment;
    in women of childbearing potential not using highly effective contraception. The only exception is a woman for whom there is no suitable alternative but who plans a pregnancy and who is fully informed about the risks of taking topiramate during pregnancy.
  • Pregnancy testing should be performed before initiating treatment.
  • The patient must be fully informed and understand the potential risks related to the use of topiramate during pregnancy. This includes the need for a specialist consultation if the woman is planning a pregnancy and for prompt contact with a specialist if she becomes pregnant or thinks she may be pregnant.
  • At least one highly effective method of contraception (such as an intrauterine device) or two complementary forms of contraception including a barrier method should be used during treatment and for at least 4 weeks after stopping treatment. Women using systemic hormonal contraceptives should be advised to also use a barrier method.
  • If a woman is planning to become pregnant, efforts should be made to switch to an appropriate alternative epilepsy treatment before contraception is discontinued. For the treatment of epilepsy, the woman must also be informed about the risks of uncontrolled epilepsy to the pregnancy.
  • If a woman being treated with topiramate for epilepsy becomes pregnant, she should promptly be referred to specialists to reassess topiramate treatment and consider alternative treatment options, as well as for careful antenatal monitoring and counselling.

In female children with epilepsy

  • Prescribers must ensure that parent(s)/caregiver(s) of female children using topiramate understand the need to contact a specialist once the child experiences menarche.
  • At that time, the patient and parent(s)/caregiver(s) should be provided with comprehensive information about the risks due to topiramate exposure in utero, and the need for using highly effective contraception.

As part of the implementation of the new PPP associated with Topiramate, new patient materials and information resources are being developed to go alongside the medication - to further reinforce the new information and warnings. There will also be a guide developed for Healthcare Professionals. We are in close contact with our colleagues in the HPRA regarding this, and will share these new materials on our website when they are available. These are expected in the coming weeks. 

We are fully aware of how the introduction of the PPP with Topiramate will be worrying for many women with epilepsy on the medication - particularly those who are planning to start a family. PLEASE DO NOT cease taking your medication without first speaking to your medical team. If you have any concerns, seek advice from your epilepsy specialist team. Tell your doctor immediately if you become pregnant or think you may be pregnant.

It is important to note that there is a risk with all medications when taken during pregnancy, and pre-conceptual planning with your medical team is highly recommended in order to take tailored decisions that are best suited for you and your child. You can read more about this by visiting the ‘Pregnancy’ section of our website.  

Further information