PRAC Recommends New Restrictions on Topiramate in Pregnancy

The European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended new measures designed to avoid topiramate (multiple brands) use during pregnancy.

While it’s well known that topiramate can cause major congenital malformations and fetal growth restriction when used during pregnancy, recent data also suggest a possibly increased risk for neurodevelopmental disorders when topiramate is used during pregnancy, the EMA says in a statement. 

The data include two observational studies that showed children born to mothers with epilepsy and who were exposed to topiramate in the womb may have a two- to threefold higher risk for neurodevelopmental disorders, in particular autism spectrum disorders (ASD), intellectual disability, or attention deficit hyperactivity disorder (ADHD), compared with children born to mothers with epilepsy not taking antiepileptic medication.

For patients using topiramate for the treatment of epilepsy, the PRAC now recommends that the medicine not be used during pregnancy unless no other suitable treatment is available.

The PRAC had also recommended a pregnancy prevention program to avoid exposure of the developing fetus to topiramate. “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 EMA says.

Regardless of indication, the agency says topiramate should be used in women of childbearing age only when the following conditions of the pregnancy prevention program are met:

  • a pregnancy test before starting treatment;

  • counseling about the risks of topiramate treatment and the need for highly effective contraception throughout treatment; and

  • a review of ongoing treatment at least annually by completion of a risk awareness form

The PRAC recommends that healthcare professionals ensure women of childbearing age are fully aware of the risks of taking topiramate during pregnancy. They say alternative treatment options should be considered and the need for topiramate treatment should be reassessed at least annually.

The product information for topiramate-containing medicines will be updated to further highlight the risks for neurodevelopmental disorders and the additional safety measures to be taken.

Patients and healthcare professionals will be provided with educational materials regarding the risks of using topiramate during pregnancy, and a patient card will be provided to the patient with each medicine package. A visible warning will also be added to the outer packaging of the medicine.

The new PRAC recommendations will be sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), which will adopt a position.

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