Sodium Valproate is a medication used to control seizures, and it’s also been effective in treating bipolar disorder and migraines. Unfortunately, it is also associated with an increased risk of foetal malformation when used by pregnant women. A paper published in Neurotoxicology and Teratology is the largest to explore how the mediation impacts brain, behaviour and social development in children diagnosed with Fetal Valproate Spectrum Disorder – observing difficulties all the way into adulthood.
Exposure to valproate during pregnancy is associated with about five times as many major abnormalities as usual and can also have a significant impact on brain development. A recent Neurotoxicology and Teratology paper is the first to assess and observe neurodevelopmental difficulties in adults with Fetal Valproate Spectrum Disorder. According to the authors, individuals with Fetal Valproate Spectrum Disorder experience a range of neurodevelopmental impairments that continue into adulthood. They recommend taking a multidisciplinary approach to the care of those affected, for both children and adults, and that pharmacovigilance strategies prioritise neurodevelopmental outcomes.
“In our cohort of 99 individuals with a diagnosis of Fetal Valproate Spectrum Disorder, we found high rates of cognitive, emotional and sensory difficulties, as well as high rates of diagnosed neurodevelopmental disorders. The wide array of challenges we observed in this population emphasises that a variety of expertise is needed to support these individuals throughout their whole lives. A comprehensive package of support that is flexible to meet the unique needs of each individual is urgently needed,” says Matthew Bluett-Duncan, University of Manchester.
Highlights of the paper include results that show 68% of individuals with Fetal Valproate Spectrum Disorder were at risk for moderate or severe cognitive difficulties. The impact of these difficulties on everyday functioning is also apparent, with 78% of individuals requiring formal educational support while in school. In addition, over 60% of individuals had received a diagnosis of Autistic Spectrum Disorder, compared to the 1-2% that is observed in the general population. Finally, sensory difficulties, which can have a large impact in one’s ability to participate in education and employment, were also very common (80%).
Importantly, although the risk of experiencing difficulties may increase with the presence of physical symptoms, such as major congenital malformations, the latest findings suggest substantial neurodevelopmental impairment can be experienced both with and without accompanying physical effects.
“This means that the rate of neurodevelopmental impact is higher than that observed for major congenital malformations, which is often the sole or primary focus of pharmacovigilance initiatives. The international experience with prenatal exposure to valproate demonstrates that pharmacovigilance initiatives must be extended to include a wider set of outcomes, including neurodevelopmental features”, says Rebecca Bromley, University of Manchester and Royal Manchester Children’s Hospital.
By Anna Holm Bodin
Bluett-Duncan, M., Astill, D., Charbak, R., Clayton-Smith, J., Cole, S., Cook, P.A., Cozens, J., Keely, K., Morris, J., Mukherjee, R., Murphy, E., Turnpenny, P., Williams, J., Wood, A.G., Yates, L.M., Bromley R.L., Neurodevelopmental outcomes in children and adults with Fetal Valproate Spectrum Disorder: A contribution from the ConcePTION project, Neurotoxicology and Teratology, Volume 100, November–December 2023, 107292, DOI: 10.1016/j.ntt.2023.107292