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Antiepileptic drug pregnancy registries: do the latest findings concur?

Leticia Tornes and Cynthia L Harden

The risk of antiepileptic drug (AED) exposure to the developing fetus is of global concern. Every year, 25,000 children are born to women with epilepsy (WWE) in the USA alone. Most pregnant WWE require AEDs and, therefore, scientifically derived evidence from large studies is essential to help determine the best management. AED pregnancy registries were initiated in the early 1990s to assess pregnancy outcomes in WWE, with the aims of obtaining accurate information about AED-related teratogenesis and evaluating the risks of the newer AEDs in a timely manner. The registries have had varied methodologies, which has been, in part, dictated by the healthcare system in which they are used. Countries with nationalized healthcare systems permit population-based data gathering, whereas in areas where medical care is privatized, a more focused prospective approach is taken. Furthermore, pharmaceutical companies have supported several registries aimed at determining the risk of exposure to a single compound. Therefore, each registry has different rules for enrollment, inclusion/exclusion criteria, length and detail of follow-up, and predetermined publication criteria. Owing to these differences and because a few subjects enroll in more than one registry, the registries do not lend themselves to a meta-analytic approach. This article will summarize the major concurrent and differing findings of the current registries from the perspective of their direct impact on managing WWE during pregnancy. We will discuss registries based in the USA, UK, Australia, Finland, Sweden and from the European and International Registry of AEDs in Pregnancy (EURAP).