In the United Kingdom, already-stringent guidance on valproate in pregnancy was strengthened on March 23 when the European Medicines Agency announced new measures designed to avoid valproate exposure in pregnancy because of risk of malformations and developmental issues. The measures include a ban on valproate-containing medicines for the treatment of epilepsy during pregnancy unless no other effective treatment is available.
The risks of AEDs, and valproate in particular, in pregnancy have been documented in multiple studies suggesting that exposure may lead to cognitive impairment, neurodevelopmental disorders, and impaired IQ. However, the available data are largely from psychometric studies, Dr. Lacey and colleagues noted in their report. “It is important to know whether the psychometric differences demonstrated in research conditions translate to children in the community,” they wrote.
To address this, Dr. Lacey and coinvestigators conducted a study of standardized academic test results in children in Wales born to mothers with epilepsy who had been prescribed AEDs during pregnancy. They reviewed health records and identified 440 AED-exposed children who had available results for Key Stage 1 tests for mathematics, language, and science at the age of 7 years.
Among children whose mothers had been prescribed valproate during pregnancy, the proportion achieving U.K. minimum standards for all subjects was 12.7% lower than a matched control group, investigators said.