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Danish Study Finds Depakote May Raise Autism Risk

Dec 7, 2011 | Parker Waichman LLP

Taking Depakote and other valproate drugs during pregnancy could make it more likely that a child will develop autism spectrum disorder (ASD), according to a new study out of Denmark.   The study is just more evidence that Depakote should be avoided in pregnancy whenever possible.

Valproate products are FDA-approved drugs to treat epileptic 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.

Pregnant women have long been advised against valproate products in pregnancy. In 2009, their association with neural tube birth defects prompted the U.S. Food & Drug Administration (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. 

Then in June, the FDA issued a Drug Safety Communication after 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 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. 

According to a HealthDay report, this new Danish study involved birth data that included nearly 656,000 children born in Denmark between 1996 and 2006 to 428,000 women.  In total, the research team identified 508 children who were likely exposed to valproate before birth, of which 14 developed autism.   Of the group not exposed to valproate, only .08 percent developed ASD. 

The study found that fetal exposure to valproate was associated with a 2.6 times more likely to suffer from ASD, after accounting for maternal age, the child's gender and other autism risk factors.  The risk was the same whether mothers took valproate alone or with another epilepsy drug, according to HealthDay.

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