By Sarah Mirando  |  April 15, 2013

Category: Pharmaceuticals
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Study Seeks to Clarify Depakote Birth Defect Risks

By Anne Bucher

 

Depakote birth defectsDepakote (valproate) is an antiepileptic drug that was approved in 1983. Since its release, it has become a popular drug to treat epilepsy, bipolar mania and migraines. The drug works by increasing the level of GABA in the brain, a neurotransmitter that helps prevent the brain signals that can lead to seizures. Because of its powerful nerve-soothing effect, Depakote has become the most-prescribed drug to treat manic episodes. While the drug is effective for treating these conditions, many women have reported that their children were born with Depakote birth defects, including:

  • Heart defects
  • Brain defects
  • Spina bifida
  • Cleft palate
  • Neural tube defects


Studies have shown that valproate exposure during pregnancy is associated with nearly three times the risk of serious birth defects when compared to women who did not take Depakote during pregnancy.

Depakote Linked to Birth Defects and Low IQ

Currently, Emory University researchers are studying the long-term effects on children who were exposed to Depakote in utero. Specifically, the researchers are looking for the long-term intellectual and neurobehavioral outcomes of the children whose mothers took Depakote during pregnancy. This study is intended as a follow-up study to clarify the findings of a similar Depakote birth defect study that was published in the New England Journal of Medicine in 2009. The Emory study is scheduled to reach completion in 2017.

In 2009, the U.S. Food and Drug Administration (FDA) issued a warning to health care professionals about the increased risk of birth defects for women who used Depakote during pregnancy. Once this link was known, numerous women began filing Depakote lawsuits, alleging that the manufacturer knew of the risks but failed to provide adequate warning.

In 2011, the FDA released an updated warning that children born to mothers who took Depakote during pregnancy may have a lower IQ than women who relied on different anti-seizure medications during their pregnancies.

The FDA has classified Depakote as a category D drug. Category D drugs have the potential to cause serious fetal harm when the drug is taken during pregnancy. The agency has included a recommendation that women who intend to become pregnant should not use Depakote if possible. Pregnant women who suffer from seizures may put both themselves and their unborn children at risk if they do not take anti-seizure medication. Women who are considering becoming pregnant should discuss their options with their physicians before switching medications.

Take Legal Action

If your child suffered from Depakote birth defects, you may have grounds to take legal action against Abbott Pharmaceuticals. Many women have already filed lawsuits against Abbott, alleging that the company did not adequately warn about the heightened risk of birth defects associated with Depakote. They claim that, had they known of these risks, they would not have used Depakote during their pregnancies. For more information about your legal rights, visit the Depakote Birth Defect Class Action Lawsuit Investigation page. A Depakote birth defect lawyer will conduct a free case evaluation to determine whether you qualify to file a lawsuit. By taking legal action, you may be able to recover for the damages you suffered from the Depakote birth defects.

 
 

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Updated April 15th, 2013

 

All medical device, dangerous drug and medical class action and lawsuit news updates are listed in the Drug and Medical Device section of Top Class Actions.

 

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