The American Academy of Neurology makes that stark recommendation amidst concerns that valproate promotes incidence of autism and lowers IQ in school-age children.
Researchers behind the British study advocate caution.
“Women for whom valproate is a treatment option should discuss the risks and benefits of this drug with their doctor prior to pregnancy, to ensure that their health and that of the potential child is optimized,” said Rebecca Bromley, a clinical psychologist and research associate at the University of Liverpool.
Bromley led the small British study, which was published at the end of January in the Journal of Neurology, Neurosurgery & Psychiatry (1/30/13). Bromley and her team assembled data from more than 500 women over a four-year period from 2000 to 2004. Half of the roughly 500 participants suffered from epileptic seizures, and of that number, all but 34 used drugs to manage and control their seizures.
Depakote was one of several drugs used by those study participants opting for medication to manage their seizures. In total, data was available from 415 children borne by study participants.
Of that number, 19 were diagnosed with some degree of developmental difficulty by six years of age. Of those 19, three also exhibited with some degree of physical impairment or birth defect. A total of 12 had an autism spectrum disorder, one was diagnosed with attention-deficit/hyperactivity disorder (ADHD), three children had ADHD alone and four presented with dyspraxia, a condition causing poor physical coordination.
While the researchers found that children born from women who suffered from epileptic seizures had a greater prevalence of neurodevelopmental problems than children whose mothers did not have epilepsy, the telling statistic involves the role Depakote plays in those children who did present with developmental difficulty.
According to the researchers, neurodevelopmental problems were more prevalent amongst children born of mothers who took Depakote in isolation or in combination with other drugs. In 12 percent of the cases, mothers who took valproate (Depakote) while pregnant gave birth to offspring with developmental problems. That number rose to 15 percent when Depakote was taken in concert with other medications.
The study authors were quick to point out that not every child is affected, and while exposure to valproate increases the level of risk with regard to Depakote birth defects, “we do not yet understand the mechanism behind the association,” Bromley said.
Nonetheless, the numbers are compelling. Researchers found that the likelihood of neurodevelopmental disorders increased in concert with higher doses of valproate. And overall, children exposed to Depakote alone, or in concert with other drugs while in the womb, were six and 10 times at a greater respective risk for developmental problems and Depakote side effects than children whose mothers were not given to epileptic seizures.
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“There is still a lot of valproate being used in women of childbearing age, probably more than we should be using. We have a lot of alternate drugs that can be tried,” he said.
In the meantime, many a Depakote lawsuit has been filed by mothers who gave birth to children with physical or neurological deficits, and by adult children whose lives have been negatively impacted due to valproate use by their mothers. Many women were not aware of the risks.