2023 – Pregnancy Prevention Programme for Topiramate

We are happy to inform you, due to an agreement between European Medicines Agency (EMA) and Health Products Regulatory Authority (HPRA) healthcare professionals will be sent a letter to inform them of the implementation of Pregnancy Prevention Programme for those on any medication containing Topiramate.

This recommendation came from the EMA’s agency Pharmacovigilance Risk Assessment Committee (PRAC) following their assessment which found that the risks of neurodevelopmental issues due to taking Topiramate during pregnancy was more significant than previously thought.

34th Annual ENTIS Conference,

See the key elements of the pregnancy prevention programme.

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 or migraine (use in this indication for women of childbearing potential only)

• Alternative therapeutic options should be considered.

• The need for topiramate treatment in these populations should be reassessed at least annually.

In women of childbearing potential:

• Topiramate for migraine prophylaxis is contraindicated:

• in pregnancy,

• in women of childbearing potential not using highly effective contraception.

• 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 or migraine 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.

• If a woman being treated with topiramate as migraine prophylaxis becomes pregnant, treatment should be stopped immediately. The woman should be referred to a specialist for careful antenatal monitoring and counselling.

In female children (for epilepsy only):

• 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.

Educational material:

In order to assist healthcare professionals and patients in avoiding exposure to topiramate during pregnancy and to provide information about the risks of taking topiramate during pregnancy, educational materials will be put in place including:

• a guide for healthcare professionals involved in the care of female children and women of childbearing potential using topiramate including a risk awareness form, which must be used and signed at the time of treatment initiation and during each annual review of topiramate treatment by the treating physician.

See link: Important Safety Information – Topamax (Topiramate)   

We will update you when we receive more information on this topic via our social media outlets.

Do NOT stop taking your medication