The FDA has advised physicians and consumers that babies exposed to valproate sodium and related products during pregnancy face an increased risk of:

  • Neural tube defects (brain and spinal cord)
  • Craniofacial defects (abnormally formed face and skull enclosing the brain)
  • Cardiovascular malformations (abnormally formed heart or blood vessels).

Neural tube defects of the brain and spinal cord include the condition known as “spina bifida,” in which neural tubes fail to develop or close properly, causing defects in the spinal cord and in the bones of the backbone (vertebrae). Spina bifida can cause mild-to-severe physical disabilities (mobility, coordination) and mental disabilities such as difficulty paying attention, problems with language and reading comprehension and trouble learning math.

Among the craniofacial birth defects linked to expectant mothers’ use of valproate is cleft palate, which is an opening in the roof of the mouth (palate).