The U.S. Food and Drug Administration (FDA) is informing the public that children born to mothers who take the anti-seizure medication valproate sodium or related products (valproic acid and divalproex sodium) during pregnancy have an increased risk of lower cognitive test scores than children exposed to other anti-seizure medications during pregnancy. This conclusion is based on the results of epidemiologic studies that show that children born to mothers who took valproate sodium or related products throughout their pregnancy tend to score lower on cognitive tests (IQ and other tests) than children born to mothers who took other anti-seizure medications during pregnancy.
In the primary epidemiologic study upon which FDA’s conclusion is based, cognitive tests were performed at age three. In supportive studies, cognitive tests were performed at ages five to 16. Cognitive tests are commonly used to assess development in a variety of areas, including intelligence, abstract reasoning, and problem solving.
The long-term effects on cognitive development from exposure to valproate sodium or related products during pregnancy are unknown. It is also not known whether these effects occur when fetal exposure is limited to less than the full duration of pregnancy, such as the first trimester.
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.
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FDA Drug Safety Communication: Children born to mothers who took Valproate products while pregnant may have impaired cognitive development
Safety Announcement
Additional Information for Patients
Additional Information for Healthcare Professionals
Data Summary
References
Safety Announcement
[6-30-2011] The U.S. Food and Drug Administration (FDA) is informing the public that children born to mothers who take the anti-seizure medication valproate sodium or related products (valproic acid and divalproex sodium) during pregnancy have an increased risk of lower cognitive test scores than children exposed to other anti-seizure medications during pregnancy. This conclusion is based on the results of epidemiologic studies that show that children born to mothers who took valproate sodium or related products throughout their pregnancy tend to score lower on cognitive tests (IQ and other tests) than children born to mothers who took other anti-seizure medications during pregnancy.
Facts about Valproate
Valproate products are FDA-approved drugs to treat seizures, and manic or mixed episodes associated with bipolar disorder (manic-depressive disorder), and to prevent migraine headaches. They are also used off-label (for unapproved uses) for other conditions, particularly for other psychiatric conditions.
Valproate products include: valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, and Depakote ER), valproic acid (Depakene and Stavzor), and their generics.
In the primary epidemiologic study upon which FDA’s conclusion is based, cognitive tests were performed at age three. In supportive studies, cognitive tests were performed at ages five to 16. Cognitive tests are commonly used to assess development in a variety of areas, including intelligence, abstract reasoning, and problem solving.
The long-term effects on cognitive development from exposure to valproate sodium or related products during pregnancy are unknown. It is also not known whether these effects occur when fetal exposure is limited to less than the full duration of pregnancy, such as the first trimester.
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.
FDA previously warned pregnant women and women of childbearing age about valproate use during pregnancy due to the known risk of birth defects (teratogenic effects) of these products. A teratogen is anything known to cause birth defects during development of an embryo or fetus. Valproate products are assigned to Pregnancy Category D. FDA released an Information for Healthcare Professionals1 communication in December 2009 on the risk of neural tube birth defects following exposure to valproate products during pregnancy.
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Drug Safety and Availability > FDA Drug Safety Communication: Children born to mothers who took Valproate products while pregnant may have impaired cognitive development
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