The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has put forth a series of new recommendations aimed at preventing the utilization of topiramate (available under multiple brands) during pregnancy.
While the adverse effects of topiramate on fetal health, such as major congenital malformations and fetal growth restriction, have long been recognized, recent data has raised concerns about a potential elevated risk of neurodevelopmental disorders in infants when topiramate is administered during pregnancy, as highlighted in a statement by the EMA.
The PRAC’s recommendations come in response to mounting evidence and concerns regarding the use of topiramate in pregnant individuals. These strengthened restrictions underscore the importance of caution and careful consideration of alternatives when addressing medical conditions in women of childbearing potential to safeguard both maternal and fetal health.
