Study: Depakote during pregnancy linked to autism in children

Study results published Tuesday in JAMA suggest that children born to mothers who used AbbVie’s Depakote (valproate) during pregnancy were five times more likely to have autism and three times more likely to have autism spectrum disorder than their peers born to mothers who did not use the drug, which is used for the treatment of epilepsy and other neuropsychological disorders. While the researchers noted that "even a moderate increase in risk may have major health importance," they remarked that the "absolute risk of autism spectrum disorder was less than 5 percent, which is important to take into account when counseling women about the use of [Depakote] in pregnancy."

Study researchers analysed data on 655 615 children born in Denmark from 1996 through 2006. During the study period, 5437 children were diagnosed with autism spectrum disorder, including 2067 with childhood autism. The researchers noted that in this cohort, 2644 children were exposed to antiepileptic drugs during pregnancy, including 508 exposed to Depakote. In 14 years of follow up, use of Depakote during pregnancy was associated with an absolute risk of 4.42 percent for autism spectrum disorder and 2.5 percent for childhood autism, compared with a total risk of 1.53 percent for autism spectrum disorder and 0.48 percent for childhood autism.

When the researchers limited the data set to include only children born to women with epilepsy, 432 children were exposed to Depakote. The absolute risk for developing autism spectrum disorder was 4.15 percent and the risk for childhood autism was 2.95 percent among those exposed to the drug, compared to a 2.44 percent risk for autism spectrum disorder and 1.02 percent risk for childhood autism among children not exposed to the therapy.

In an accompanying editorial, Kimford Meador called the data "the strongest evidence to date that there is a link between fetal exposure and childhood autism or autism spectrum disorder." In the case of Depakote, he noted that "the amount being used in women of childbearing age seems to be excessive given the risk benefit ratio. There’s alternative drugs that have lower risks." Looking ahead, Meador called for additional studies to better understand how seizure drugs and other treatments affect unborn children.

In 2011, the FDA warned women that use of Depakote was associated with lower cognitive scores in children whose mothers took the drug during pregnancy and had previously warned that the medicine was linked to birth defects, including heart defects, spina bifida, cleft palates and cognitive problems.

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