Topiramate exposure in pregnancy: PRAC recommends new measures

The European Medicines Agency (EMA) is recommending new measures to prevent children’s exposure to topiramate-containing medicines during pregnancy due to an increased risk of neurodevelopmental problems. Topiramate, used for epilepsy and migraine treatment, has known birth defect risks when used during pregnancy.

The recommendations include:

  • Topiramate should not be used to prevent migraines or for weight management during pregnancy.
  • Pregnant epilepsy patients should only use topiramate if no alternative treatment is available.
  • Implementing a pregnancy prevention program to educate women about the risks of topiramate during pregnancy and the need for contraception while taking it.
  • Healthcare professionals should assess patients’ need for topiramate treatment annually.

The product information for topiramate-containing medicines will be updated to emphasize these risks. Patients will receive educational materials and a patient card with each medicine package. Healthcare professionals must carry out drug utilization studies to assess the effectiveness of these measures.

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