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FDA Drug Safety Podcast for Healthcare Professionals: Children born to mothers who took Valproate products while pregnant may have impaired cognitive development

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Welcome, my name is Jennifer Shepherd, a pharmacist in the Division of Drug Information. On June 30, 2011, the Food and Drug Administration issued a Drug Safety Communication informing the public that children born to mothers who take the anti-seizure medication valproate sodium or related products, such as 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, such as 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.

FDA previously warned pregnant women and women of childbearing age about valproate use during pregnancy due to the known 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 Professionals communication in December 2009 on the risk of neural tube birth defects following exposure to valproate products during pregnancy. 

At this time, FDA recommends that Healthcare Professionals:

  1. Inform women of childbearing age of the increased risk for adverse effects on cognitive development with prenatal valproate exposure.
  2. Continue to counsel women of childbearing potential taking valproate about the increased risk of major malformations, including neural tube defects, when valproate is used during pregnancy.
  3. Weigh the benefits and risks of valproate when prescribing this drug to women of childbearing age, particularly when treating a condition not usually associated with permanent injury or death. Alternative medications that have a lower risk of adverse birth outcomes should be considered. Healthcare professionals should discuss the relative risks and benefits of appropriate alternative therapies.
  4. Know that untreated or inadequately treated epilepsy or bipolar disorder during pregnancy increases the risk of complications in both the pregnant mother and her developing baby.
  5. Recommend use of effective contraception for women who are not planning a pregnancy if the decision is made to prescribe valproate to women of childbearing age.
  6. Inform patients of the North American Antiepileptic Drug Pregnancy Registry and encourage patients who become pregnant to enroll by calling 1-888-233-2334.
  7. Report adverse events involving valproate to the FDA MedWatch program at www.fda.gov/medwatch.

Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information. Please read the Drug Safety Communication for the complete data summary and background information detailing this communication. A link to this DSC can be found at www.fda.gov/Drugs/DrugSafety. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.


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