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Depakote, Other Valproate Medications in Pregnancy May Lower Child's IQ

Sep 6, 2011 | Parker Waichman LLP

Depakote and other forms of valproate medications could impact the cognitive ability of children if they are taken during pregnancy, according to a Drug Safety Communication issued by the U.S. Food & Drug Administration (FDA) in June.  The FDA alert was based on epidemiologic studies that show that children born to mothers who took Depakote or similar drugs throughout their pregnancy tend to score lower on IQ tests than children born to mothers who took other anti-seizure medications.

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.   In addition to Depakote, these drugs are also sold under the names Depacon, Depakene, and Stavzor.  They are also sold as generics.

According to the FDA Drug Safety Communication issued on June 30, several published epidemiological studies have indicated that children exposed to valproate in utero have lower cognitive test scores than children exposed to either another antiepileptic drug in utero or to no antiepileptic drugs in utero.  The largest of the studies examined by the FDA was a prospective cohort study conducted in the United States and United Kingdom that found children with prenatal exposure to valproate throughout pregnancy had lower Differential Ability Scale (D.A.S) scores at age 3, compared to those taken alternative medications. The D.A.S. is a measure of cognitive development performed in children who are too young to undergo IQ testing, and generally correlates with IQ scores later in childhood.

While all of the studies examining this issue have methodological limitations, the FDA concluded that the weight of the evidence supports the conclusion that valproate exposure in utero causes subsequent adverse effects on cognitive development in offspring.

The FDA advised that the risks and benefits of Depakote and other valproate products should be carefully weighed when prescribing these drugs to women of childbearing age, particularly for conditions not usually associated with permanent injury or death.  If the use of valproate is not essential, alternative medications that have a lower risk to the should be considered in pregnant women and women of childbearing age.  If the decision is made to use valproate in women of childbearing age, effective birth control should be used, the agency said.

This is not the first time adverse effects on fetal development have caused concern about Depakote and other valproate drugs.  In 2009, their association with neural tube birth defects prompted the FDA to warn that women of childbearing potential should only use drugs like Depakote if it is essential to manage their medical condition.   Such drugs are currently classified by the FDA in Pregnancy Category D, which means that there exists positive evidence of human fetal risk.

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