Development of EpiRisk: An online clinical tool for estimating the risk of major congenital malformations in pregnant women treated for epilepsy

Antiepileptic drugs (AEDs) are known to associate with an increased risk of major congenital malformations (MCMs) in children born to women who become pregnant while taking them. As the indications for AEDs continue to diversify, novel AEDs emerge, and polytherapy becomes more prevalent, the volume and complexity of the information relating to teratogenic risk can become unmanageable for the clinician. This in turn makes accurate education of pregnant women treated with AEDs regarding the risk of MCMs challenging. To enable clinicians to provide better information regarding the potential teratogenic risk of AEDs, we outline here the method we have employed to underpin a new system of real-time risk analysis, “EpiRisk.” When launched, EpiRisk will offer a user-friendly, online clinical tool, compatible with all modern Internet browsers, smart phones, and personal computers. Using the most current published data, as well as “real world” data from the UK and the Australian Pregnancy Registers, EpiRisk will enable clinicians to quickly and accurately assess the teratogenic risk of AEDs in mono- and polytherapy. EpiRisk may thus provide a future-proof central hub for empowering patients, clinicians, and registries by delivering evidence-based information on the teratogenic risk of the AEDs in pregnant women with epilepsy through an easily accessible platform.