The FDA added warnings to labels on valproate-containing drugs in 2011 to include information about the risk of impaired cognitive development in children born to mothers who took valproate sodium or related products during pregnancy.
In May 2013, the FDA directed that labels of valproate-containing drugs be updated to include a stronger warning about the increased risk of neural tube defects (spina bifida) and other major birth defects, such as craniofacial defects (cleft palate) and cardiovascular malformations, in babies born to mothers exposed to valproate during pregnancy.
The FDA also added information about the risk of lower cognitive test scores.
In its 2103 statement, the FDA said valproate’s pregnancy category for migraine treatment would be changed from “D” (the potential benefit of the drug in pregnant women may be acceptable despite its potential risks) to “X” (the risk of use in pregnant women clearly outweighs any possible benefit of the drug).
The FDA says it will continue to evaluate information about the potential risks of valproate use during pregnancy and will update the public as more information becomes available.