Reported in a July 2013 Everyday Health article, a study performed by the Aarhus University Hospital in Denmark found correlation between valproate use and increased risks of autism.
Researchers followed 655,615 women and their children born from 1996 to 2006, observing the group for potential signs of autism and triggers. Data from national registries revealed 5,437 children had been diagnosed with autism spectrum disorder or childhood autism, and out of this group, 508 had been exposed in utero to valproate.
From this group, usage of valproate during pregnancy appeared to be associated with an absolute risk of 4.42 percent for autism spectrum disorders and 2.5 percent for childhood autism. However, the women who had taken valproate during pregnancy were five times more likely to have a child diagnosed with autism over time.
While valproate, including brand name Depakote, is considered an effective treatment for epilepsy, migraines, and bipolar disorder and the American Academy of Neurology recommends pregnant women avoid this medication and seek out alternative treatments, a risk still exists even when usage stops before conception.
This study comes after several years of studies finding a link between Depakote usage and congenital malformations and cognitive development concerns. More recently, the U.S. Food and Drug Administration issued a safety warning in May 2013, stating that Depakote has been contraindicated for migraine prevention in women because of studies associating it with decreased IQ scores in children.
Prior to this recent instance, the FDA warned patients in 2006 about a wide range of birth defects associated with taking Depakote and fetal exposure, including the following: spiral bifida, neural tube defects, cardiac defects, facial clefts, cleft palate, hypospadias, craniosyntosis, limb defects, cognitive development, and symptoms similar to fetal alcohol syndrome.
Presently, Depakote manufacturer Abbott Laboratories is being sued over a lack of warnings and unethical marketing practices, including promoting it for dementia treatment without approval.