FDA Warns of Cognitive Delay in Offspring With Valproate

The US Food and Drug Administration (FDA) has issued a safety announcement to underline the increased risk for lower cognitive test scores among children born to mothers taking the antiseizure medication valproate sodium or the related products valproic acid and divalproex sodium during pregnancy, relative to other antiepileptic medications.

Valproate products are approved to treat seizures and manic or mixed episodes associated with bipolar disorder (manic-depressive disorder), and to prevent migraine headaches, a MedWatch alert notes. They are also used off-label for other conditions, particularly other psychiatric conditions.

“FDA has evaluated all available evidence to date, and will be adding information about the risk of lower cognitive test scores to the valproate product labels in the Warnings and Precautions section, the Use in Specific Populations: Pregnancy section, and to the Medication Guides that are being developed for the valproate drug products,” the alert notes.

The FDA previously warned pregnant women and women of childbearing age about valproate use during pregnancy because of known teratogenic effects, and valproate products are assigned to Pregnancy Category D. The FDA also released an Information for Healthcare Professionals communication in December 2009 on the risk for neural tube birth defects after exposure to valproate products during pregnancy.

Their conclusion is based on epidemiologic studies showing that children exposed to valproate in utero tend to score lower on cognitive testing than children exposed to other agents….

Reported by Susan Jeffrey
Medscape Medical News

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