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The findings of a new study suggest that the side effects of using the antiepileptic drug Depakote during pregnancy may reduce the cognitive abilities in children.
Researchers from Emory University in Atlanta found that the I.Q. of children born to mothers who took Depakote (valproate) while pregnant were seven to 10 points lower than other children at age six. They also found reduced language skills and memory in those children as well.
The study, published online on January 22 in The Lancet Neurology, collected data on 224 children. Researchers found that children exposed to valproate had less verbal and memory abilities when compared to children whose mothers took other antiepileptic drugs while pregnant. The results were dose-specific, meaning that the more the mother took while pregnant, the worse their children’s I.Q. and cognitive abilities, which researchers take as a strong sign of association.
Depakote was approved in the U.S. in 1978 for the treatment of certain forms of epilepsy, containing valproate in tablet form. Other versions of the drug are marketed as Depacon for intravenous injection and Depakene in syrup form.
Side effects of Depakote during pregnancy have been linked to an increased risk of a number of severe birth defects, especially when the drug is taken during the first 28 days, when neural tube closure and other critical formations are taking place.
Prior studies have suggested that children may face a risk of cognitive problems when Depakote is used during pregnancy, and the researchers in this latest study indicate that their findings seem to confirm those previous reports.
“High doses of valproate were negatively associated with IQ, verbal ability, non-verbal ability, memory, and executive function, but other antiepileptic drugs were not,” the researchers determined.
In 2006, the FDA added a “black box” warning about the potential risk of Depakote birth defects after a study found that 20% of pregnant mothers who gave birth while on Depakote had a child with malformations or a birth defect.
Abbot Laboratories, the manufacturer, faces an increasing number of Depakote lawsuits filed on behalf of children born with birth defects or malformations, alleging that the drug maker failed to adequately warn consumers or the medical community about the risks associated with using the drug during pregnancy.
In May, Abbott agreed to pay $1.6 billion to the Justice Department for illegally marketing Depakote. Its sales representatives promoted it to treat schizophrenia and tried to convince nursing homes to use Depakote to pacify elderly dementia patients, which is many consider a form of nursing home abuse from chemical restraint. Neither use was approved by the FDA.