Pregnancy Warning Issued for Depakote and Other Valproate Medications

Last updated: May 2013

The U.S. Food and Drug Administration has issued a warning regarding medications including and related to valproate sodium. Due to the risk of decreased IQ scores in children whose mothers took valproate medications during pregnancy, the FDA stated that it no longer be used for migraine prevention by pregnant women and labeled it a category X medication (the drug's risks outweigh the drug's benefits for this use). Additionally the FDA added that women who may become pregnant should not use the product unless it is vital to controlling their medical conditions, and only if there is no other alternative.

Valproate products are FDA approved for the prevention of migraines, in addition to other uses including treatment of epilepsy and treatment of manic episodes associated with bipolar disorder.

As stated by Russell Katz, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research, “Valproate medications should never be used in pregnant women for the prevention of migraine headaches because we have even more data now that show the risks to the children outweigh any treatment benefits for this use.” 1

Medications included in this new warning include valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, and Depakote ER), valproic acid (Depakene and Stavzor), and their generics.

Read the the complete FDA Press Announcement for additional information.

If you are currently taking any of these medications, do not suddenly stop or change your treatment program without discussing with your healthcare provider.

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