Scandinavian multi-registry study of antiepileptic drug teratogenicity (SCAN-AED)

Exposure to antiepileptic drugs (AEDs) during pregnancy increases the risk for major congenital malformations (MCM) and autism spectrum disorders (ASD). However, most pregnant women on antiepileptic drugs have to continue medication use in pregnancy to avoid epileptic seizures.

Unfortunately many AED and AED combinations are not recommended in pregnancy due to lack of safety documentation. Most women on AEDs during pregnancy are advised to take a dose of folic acid 10 times higher than recommended for other women. It is not known if this reduces the harmful effects of AEDs on the child, or if the high dose may even be harmful for the mother.

We aim to investigate MCMs and ASDs after exposure to a high number of AEDs and AED combinations. We will also investigate if high dose folic acid modifies the risk of MCMs and ASD after AED exposure in the children and regarding long term and short term risks. We will also investigate the impact of environmental factors including low socio-economic status on risk of AED teratogenicity.

By linking three health registers: The medical birth registry, the prescription databases, the hospital registry as well as socio-economic data from Norway, Sweden and Denmark we will have a large and unique dataset. The dataset will contain the information and the statistical power needed to investigate these issues.

The project is a collaboration between epilepsy and register scientists in Norway, Sweden and Denmark. The results will be published in high impact journals on open science platforms. They will contribute to individualized treatment of women with epilepsy and improved outcome for their children.