The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has put forth recommendations for implementing new measures aimed at preventing children’s exposure to medicines containing topiramate in the womb. This decision arises from concerns that topiramate may elevate the risk of neurodevelopmental issues when used during pregnancy.
Topiramate, which has been off-patent for several years, is already recognized for its potential to cause severe birth defects when taken during pregnancy. Originally marketed by Johnson & Johnson in the USA under the trade name Topamax, it was used as an add-on therapy for partial onset seizures in adults.
Topiramate-containing medicines are employed within the European Union for epilepsy treatment and migraine prevention. In some EU countries, it is also used in combination with phentermine for weight management. Currently, topiramate is contraindicated for migraine prevention and weight management during pregnancy, and women of childbearing potential using topiramate must utilize effective contraception.
For patients prescribed topiramate for epilepsy management, the PRAC now recommends refraining from its use during pregnancy unless there are no other suitable treatment options available.
Additionally, the PRAC proposes the establishment of a pregnancy prevention program to prevent fetal exposure to topiramate. This program will educate women and girls of childbearing age about the risks associated with topiramate during pregnancy and the importance of avoiding pregnancy while taking the medication.
These recommendations follow a comprehensive review of available data. The product information for medicines containing topiramate will be updated to emphasize the risks and the necessary precautionary measures.
As part of its mandate to provide safety-related advice to other EMA committees, the PRAC has approved a direct healthcare professional communication (DHPC) to inform healthcare professionals about the implementation of the new measures as part of the pregnancy prevention program for topiramate-containing medicinal products.
Healthcare professionals are advised to consider alternative treatment options for all women of childbearing potential and to reassess the need for topiramate treatment annually. Ongoing treatment should be re-evaluated to ensure that the new measures are being adhered to. Healthcare providers must also ensure that all female patients of childbearing potential are well-informed about the risks associated with taking topiramate during pregnancy.
The DHPC will undergo evaluation by the Coordination Group for Mutual Recognition and Decentralized Procedures – Human (CMDh). Subsequently, the marketing authorization holder will disseminate the DHPC to healthcare professionals.
