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Researchers from the U.K. have found that the side effects of fetal exposure to Depakote and similar epilepsy drugs may lead to poorer academic achievement later in life for children.
In a study published this week in The BMJ, researchers warn that in utero exposure to valproate, the active ingredient in Depakote, was linked to a significant decrease in cognitive testing scores for seven year old children.
Depakote (valproate) is prescribed for treatment of seizures and bipolar disorder, as well as migrain headaches, but has been linked to a number of serious health concerns for unborn children when used by pregnant women.
Researchers with the Wales Epilepsy Research Network and the Institute for Psychological Medicine and Clinical Neurosciences conducted this latest study to investigate whether fetal Depakote exposure affected children academically in the real world. In order to do so, they looked at healthcare records to identify children born to mothers with epilepsy, and then looked at what drugs their mothers took and their national test scores in math, language and science at age seven.
According to the findings, children whose mothers took Depakote or a similar valproate-based drug overall scored about 12% less than other children in math and science, and 10% less in language. When they looked at children whose mothers took multiple anti-epilepsy drugs (AEDs), the scores dropped to about 20% lower than other children.
“In utero exposure to AEDs in combination, or sodium valproate alone, is associated with a significant decrease in attainment in national education tests for 7-year-old children compared with both a matched control group and the all-Wales national average,” the researchers concluded. “These results give further support to the cognitive and developmental effects of in utero exposure to sodium valproate as well as multiple AEDs, which should be balanced against the need for effective seizure control for women during pregnancy.”
The findings are very similar to an epilepsy drug study published in February in JAMA Neurology, by researchers from Denmark. That study also found that children who were exposed to Depakote in the womb scored lower on language and math tests in the sixth grade, when compared to their peers. That study also found that children exposed to Klonopin suffered lower language test scores, though not lower in math.
In 2006, the FDA added a “black box” warning about the potential Depakote pregnancy side effects, after a study found that 20% of pregnant mothers who gave birth while on Depakote had a child with malformations or a birth defect.
In May 2013, the FDA put new restrictions on Depakote pregnancy use, contraindicating it for pregnant women, but only when it was used for the treatment of migraines. The agency did not contraindicate it for pregnant women using it to treat epilepsy. The FDA changed all valproate-based drugs from a class “D” to a class “X” pregnancy drug, but only as they pertain to migraines.
Abbott Laboratories and AbbVie, a subsidiary it spun off, have faced hundreds of Depakote lawsuits in state and federal courts nationwide. Plaintiffs say the company should be held liable for failing to warn women and the medical community about the risks associated with using the medication during pregnancy.
Before the drug’s patent expired in 2007, Depakote was a blockbuster drug generating about $1.5 billion in annual sales for AbbVie’s predecessor.