During its September 2023 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency, recommends new measures to avoid exposure of children to topiramate-containing medicines in the womb, because the medicine may increase the risk of neurodevelopmental problems after exposure during pregnancy.
The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) recommends new measures to avoid exposure of children to topiramate-containing medicines in the womb, because the medicine may increase the risk of neurodevelopmental problems after exposure during pregnancy. Topiramate is already known to cause serious birth defects when used during pregnancy.
Topiramate‑containing medicines are used in the European Union for the treatment of epilepsy and prevention of migraine. In some European Union countries, the medicine is also used in combination with phentermine for weight reduction. At present, topiramate must not be used to prevent migraine or manage body weight during pregnancy and patients who can become pregnant must use effective birth control when using topiramate.
For patients using topiramate for the treatment of epilepsy, the PRAC is now recommending that the medicine should not be used during pregnancy unless there is no other suitable treatment available.
The PRAC also recommends additional measures, in the form of a pregnancy prevention programme, to avoid exposure of children to topiramate in the womb. These measures will inform any woman or girl who is able to have children of the risks of taking topiramate during pregnancy and the need to avoid becoming pregnant while taking topiramate.
The recommendations follow the PRAC’s review of available data. The product information for topiramate-containing medicines will be updated to further highlight the risks and the measures to be taken.
More information is available in EMA’s public health communication.
New safety information for healthcare professionals: restrictions to prevent exposure during pregnancy
As part of its responsibility to give advice on safety-related aspects to other EMA committees, the PRAC agreed to a direct healthcare professional communication (DHPC) informing healthcare professionals about the implementation of new measures under a pregnancy prevention programme for topiramate-containing medicinal products. For all women of childbearing potential, alternative treatment options should be considered and the need for topiramate treatment should be reassessed at least annually. Ongoing treatment should be re-evaluated to confirm that the new measures have been taken. Healthcare professionals should ensure that all patients who can become pregnant are fully aware of the risks of taking topiramate during pregnancy.
This DHPC will be forwarded to the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh). Following the CMDh opinion, the DHPC will be disseminated to healthcare professionals by the marketing authorisation holder, according to an agreed communication plan, and published on the Direct healthcare professional communications page and in national registers in member states.
In Belgium, medicinal products containing topiramate are available under the commercial names Topamax and Topiramate EG.
More information is available on the EMA website.