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New Generic Depakote Available; Risks Abound for Pregnant Women

Oct 11, 2013

A generic version of the epilepsy drug Depakote was recently introduced to the U.S. market.

While Dr. Reddy's Laboratories Divalproex Sodium Extended Release Tablets may present a lower-cost alternative to those taking Depakote, this year two new studies have been released that further show the drug's link to dangerous side effects, namely birth defects when the drug is taken by expecting mothers.

Based on our recent reports, two studies have been published this year prior to the release of the generic form of Depakote that point to dangerous side effects that pose risks to pregnant women who take the drug to prevent seizures caused by epilepsy.

In the first study, children of women who took valproate at some point during their pregnancy were studied until age 6, and the rate of birth defects among them was higher compared to a group of children born to mothers who avoided valproate during their pregnancy terms. That study was published in the journal Neurology, Neurosurgery & Psychiatry.

A study published in March this year in the journal Acta Neurologica Scandinavica found links between valproate and birth defects, specifically spina bifida, heart malformations, larger blood vessels, and also malformations to fingers and toes, skull bones, and the brain.

Prior to these studies being published, the U.S. Food and Drug Administration (FDA) mandated that a warning be placed on safety labels of Depakote to note an association between pregnant women taking Depakote and birth defects, according to our reports.

Despite these risks, the FDA approved the generic form of Depakote, Divalproex Sodium Extended Release Tablets, for sale in the U.S.

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