The importance of pregnancy registries for the management of women with epilepsy and childbearing potential: Emphasis on EURAP

Abstract

AbstractIn light of the increased awareness of the teratogenic risks with older-generation antiseizure medications (ASMs) and the introduction of many new drugs, prospective antiepileptic drugs and pregnancy registries were introduced some 25 years ago by various independent research groups. The overall aim of these registries is to compare different treatment alternatives with respect to the risk of major congenital malformations (MCM) in the exposed offspring and thus facilitate rational, evidence-based management of women with epilepsy and childbearing potential. The UK and Ireland Epilepsy and Pregnancy Register, the North American AED Pregnancy Registry, EURAP (The International Antiepileptic Drugs and Pregnancy Registry), the Raoul Wallenberg Australian Pregnancy Register, and the Kerala Registry of Epilepsy and Pregnancy are the most important registries established for assessment of specifically the safety of ASMs. Since it is the largest, and being initially European based, EURAP is the focus of this overview of the contribution of pregnancy registries over the years. EURAP and the other registries have provided important information on pregnancy outcomes with the most frequently used ASMs in monotherapy, thereby identifying higher prevalence of MCMs with valproate and topiramate, whereas the risk appears low with lamotrigine and levetiracetam. Further, for several ASMs the risk appears to be dose-dependent. The registries continue to play an important role in efforts to assess the safety of the newer ASMs and of specific combination therapies. Unlike administrative population-based registries, these specific prospective ASM registries also include important information on the mothers’ epilepsy and seizure control.