Study: Epilepsy Drug, Valproate, Linked to Increased Autism Risks

Use of anticonvulsant drug valproate by expectant mothers has been linked to an increased autism risk in their babies, a new study reveals.

Valproate is used in the treatment of epilepsy, said the Global Times; however, its use by pregnant women was associated with a significantly increased risk of their babies developing autism, the study authors wrote. The study appears in the Journal of the American Medical Association. Valproate has also been linked to increased risks for congenital malformations and delayed cognitive development. Little information is available on valproate’s risks for other significant neuropsychiatric disorders, said the Global Times.

Researchers from Denmark’s, Aarhus University Hospital researched 665,615 babies born between 1996 and 2006. At the end of the study, the children’s average age was 8.8 years. During the study period, said the Global Times, 5,437 children were diagnosed with autism spectrum disorder (ASD). Of these, 2,067 were diagnosed with childhood autism. Of those children, the mothers of 2,644 were exposed to antiepileptic drugs during their pregnancies; 508 of these women were exposed to valproate, said the Global times.

The study authors concluded that valproate was associated with an absolute risk of 4.42 percent for ASD (compared to a total risk of 1.53 percent) and an absolute risk of 2.50 for childhood autism (compared to a 0.48 percent total risk), according to the Global Times. “For women of childbearing potential who use antiepileptic medications, these findings must be balanced against the treatment benefits for women who require valproate for epilepsy control,” the researchers wrote.

Prior studies have linked anti-seizure drugs, such as valproate, to birth defects in babies exposed to the medications in utero; however, not all anti-seizure drugs have been linked to the same birth defects.

We have also written that a Danish study revealed additional evidence that fetal exposure to Depakote, specifically its active ingredient, valproate, increases a baby’s risk of developing ASD three-fold. Depakote, approved for the prevention of migraines, treating acute manic episodes in bipolar patients, and halting seizures in adults and children, has been associated with birth defects when taken by pregnant women.

Abbott Laboratories was hit with massive fines for off-label practices last year. The fines represented the second largest such criminal fine for a single medication and were levied against Abbott following its guilty plea to a criminal misdemeanor charge over misbranding of its marketing of the drug, Depakote. The accusations included that Depakote was promoted off-label to control behavioral issues in patients diagnosed with dementia and for the treatment of schizophrenia. A Justice Department (DOJ) press release stated that neither of these uses had been approved by the U.S. Food & Drug Administration (FDA).

Prior to that, 26 women filed lawsuits claiming that the makers of the Depakote illegally marketed the drug for off-label purposes and failed to warn of the side effects of the drug. Each of the women claimed they were prescribed and took Depakote just before getting pregnant or during the first trimester of their pregnancy and that the drug caused them to give birth to children with a wide array of severe, some life-threatening, birth defects.

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