The FDA is advising health care professionals and women that valproate sodium, valproic acid, and divalproex sodium are contraindicated and should not be used in pregnant women for migraine prevention. These products are marketed as Stavzor (valproic acid; Noven), Depakote (divalproex sodium delayed-release; AbbVie), and Depakote ER (divalproex sodium extended-release; AbbVie).
Results from the Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) showed evidence that children exposed to valproate products while their mothers were pregnant had decreased IQs at age 6 compared to children exposed to other antiepileptic drugs.
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The respective drug labels will include stronger warnings about use during pregnancy, and the pregnancy category for migraine use with valproate will be changed from “D” to “X,” indicating that the risk of use in pregnant women clearly outweighs any possible benefit of the drug. Valproate products will remain a pregnancy category D for treating epilepsy and manic episodes associated with bipolar disorder.
The FDA recommends that pregnant women currently taking a valproate medication should not stop their medication but should talk to their health care professionals immediately. Stopping valproate treatment suddenly can cause serious and life-threatening medical problems to the woman or her baby.
For more information visit the FDA Safety Alerts website.