Most women with epilepsy need to continue taking anti-seizure medications during pregnancy, to protect both their own health and that of their baby. However, while these medicines can cross the placenta and reach the developing foetus, surprisingly little is known about their long-term effects on children’s health and development.
Research has traditionally focused on the risk of major physical differences present at birth, often referred to as congenital malformations, following exposure to anti-seizure medications during pregnancy. Long-running initiatives such as international pregnancy registers, as well as newer projects using healthcare datasets, have reliably tracked and reported these outcomes for many years.
Children’s health, however, extends far beyond birth. We also need to understand how exposure to anti-seizure medications may affect physical health throughout childhood, yet this area has often been neglected.
The picture is much less clear when it comes to neurodevelopment, with research in this area lagging significantly. Neurodevelopment refers to how a child’s brain develops, including learning, attention, memory, language and social skills. Studying these outcomes is more costly and complex as children need to be followed as they grow and their brains continue to develop. As a result, this area has historically received less attention and funding.
While interest is increasing, important questions remain unanswered. For example, existing evidence suggests that children exposed to the anti-seizure medications lamotrigine or levetiracetam generally develop “typically” in early childhood. However, far fewer studies have followed these children into middle childhood or adolescence, when more advanced thinking and reasoning skills develop and when young people face ever-increasing cognitive, emotional and social pressures.
We know even less about newer or less commonly prescribed anti-seizure medications, meaning that for many treatments we cannot confidently say whether they affect children’s health and development or not. In addition, very little is known about the long-term health outcomes of women with epilepsy themselves, as research has traditionally focused on pregnancy and birth outcomes rather than monitoring women over the longer term.
No single type of study can answer these questions on its own. The strongest approach is to bring together complementary sources of evidence, including detailed prospective studies, pregnancy registers and routine healthcare data. Each has different strengths, and each helps to fill the gaps left by the others.
Prospective studies (where researchers watch a group of people forward in time) provide the most detailed information because researchers can assess children directly and look closely at specific areas of health and development. Their downside is that they are expensive, limited by short-term, inconsistent funding, and are often reactive, playing catch-up to real-world challenges.
Pregnancy registers offer a more proactive approach. By routinely recruiting women during pregnancy, recording medication use and following children after birth, they can identify potential risk signals for specific treatments earlier. The UK Epilepsy and Pregnancy Register, for example, uses routine questionnaires to monitor children’s development followed by more detailed assessments when concerns arise.
Routine healthcare datasets provide the third piece of the puzzle. These datasets include larger numbers of families than traditional studies, which makes them useful for identifying possible risk signals. Although they typically contain less detailed information, when combined with register data and focused clinical studies, they help create a more comprehensive and efficient system for understanding the safety of anti-seizure medications during pregnancy.
Used together, these approaches give us the best chance of generating evidence quickly that is based on robust and clinically informative data.
This research is vital as clinicians and families are currently making treatment decisions with incomplete information. Without robust evidence, effective medicines may be avoided unnecessarily, or women may feel anxious and uncertain about continuing treatment, which could worsen seizure control. Equally, assuming a medicine is safe without enough evidence, as was seen with valproate, can expose children to avoidable harm. By generating better evidence, we can support more informed conversations between clinicians and families, increase confidence in treatment decisions and ultimately improve outcomes for both women with epilepsy and their children.
Keywords
Congenital malformations: Commonly called a birth defect, is a major structural or functional anomaly present from birth
International pregnancy registers: Observational research studies that track health outcomes for pregnant individuals exposed to specific medical products, vaccines, or chronic conditions across multiple countries.
Neurodevelopment: How the brain and nervous system grow, shape, and organize themselves from conception through early adulthood. It covers how nerve pathways form, how skills like learning, language, and emotion develop, and how the brain adapts to everyday experiences.
Prospective studies: A prospective study is a research design that watches a group of people (a cohort) forward in time. Researchers track participants and collect new data as events or health outcomes happen. This helps show how certain risks may lead to specific results.
Routine healthcare datasets: Large collections of information gathered automatically during day-to-day medical care, hospital visits, and administrative tasks. They include electronic health records, billing claims, disease registries, and mortality statistics, which researchers and public health experts use to track disease trends, plan services, and study patient outcomes.
Clinical studies: Research projects that test new medical treatments, drugs, devices, or care methods on human volunteers. They prove if a new medical option is safe and works well.
