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New Pregnancy Warning for Valproate Drugs

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The U.S. Food and Drug Administration (FDA) issued a warning that children born to women taking anti-seizure “valproate products” have an increased risk of lower cognitive test scores. On Thursday, the agency advised physicians to warn pregnant women the risk is greater compared to children exposed to other antiepileptic medications during pregnancy.

The new warning applies to Depakote, Depakon, Depakene and Stavzor, along with their generic equivalents.

The FDA based its announcement on epidemiologic study results that showed “fetal exposures to the drugs tended to correlate with lower scores on IQ and other cognitive tests,” reported HealthDay.

In late 2010, a Swedish study published in Epilepsia included 1,200 teenage children born to women with epilepsy. The reviewed data revealed children born to women who took two or more antiepileptic drugs while pregnant, performed worse in school than their peers who had no prenatal exposure to the medications.

The Swedish study results are similar to earlier research that linked prenatal exposure to antiepileptic drugs, specifically valproate products, to negative effects on the child’s ability to solve problems, process information and make decisions, says HealthDay.

The drugs have also been linked to an increased risk of birth defects such as neural tube defects, the FDA stated.

The agency approved valproate products to treat seizures, migraines and bipolar disorder; however, the medications are often used for the non-approved treatment of other psychiatric disorders.

In June, a study published in Lancet Neurology revealed 230 pregnancies involved major birth defects, including heart defects and neural tube defects such as spina bifida. The most birth defects were linked to a valproate product called valproic acid. The study included data from EURAP, an international epilepsy and pregnancy registry. Researchers observed 3,909 women and 4,540 pregnancies exposed to monotherapy with different doses of valproic acid and other antiepileptic drugs.

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