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Depakote & FDA Black Box Warning

The U.S. Food & Drug Administration (FDA) has required the labeling of the epilepsy drug Depakote to carry a ‘black box warning’ regarding an increased risk of birth defects.

Studies Have Forced The FDA To Add A Black Box Warning To Depakote

Free Depakote Birth Defects Case Evaluation: If you or a loved one has taken Depakote while pregnant and given birth to a child with birth defects, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.

What’s the problem?

Abbott Laboratories anti-epileptic drug Depakote (also sold under the brand names Depakote ER, Depakote Sprinkles, Depacon, Stavzor and generically as divalproex sodium) has been linked to Spina Bifida, Cleft Palates, limb deformity, congenital cardiac defects, facial dysmorphism, low I.Q.s, and many other birth defects as evidenced by numerous studies and a black box warning from the U.S. Food & Drug Administration (FDA).

The following is an overview of each study and the FDA’s black box warning:

American Academy of Neurology and American Epilepsy Society – found that pregnant women should avoid taking the drug Depakote (valproate) due to the risk of birth defects such as Spina Bifida, cleft palates, lower I.Q.s and others.
New England Journal of Medicine (NEJM). A 2009 study published showed that children born to mothers who took Depakote while pregnant had lower I.Q.s.

Hebrew University Study. A 2009 study by Hebrew University’s Hadassah Medical School and the Israeli Ministry of Health reported that exposure to valproic acid in pregnancy resulted in nearly three times as many major birth anomalies such as Spina Bifida.
Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) Study. A study published in the August 2006 issue of Neurology found that approximately 20.3% of pregnant women who took Depakote suffered serious adverse outcomes related to the birth of their children versus only 1% to 10.7% with other, similar drugs.

FDA Black Box Warning. The results of the NEAD study led to a Black Box warning from the FDA in October 2006, including hepatoxicity (chemical driven liver damage), teratogenicity (the capability of producing fetal malformation) and pancreatitis (the inflammation or infection of the pancreas). The FDA is currently investigating the drug’s link to autism and other developmental delays.

Depakote Birth Defects Update 1/24/13: A new study has determined that Depakote can cause lowered IQ’s and other cognitive deficiencies in children born to mothers who take the drug during pregnancy. Specifically, the research found that babies exposed to Depakote in the womb had IQ’s that were seven to 10 points lower than other children at age six, as well as reduced language skills and memory capacity. Click here to learn more.

Do I have a Depakote Birth Defects Lawsuit?

The Product Liability Litigation Group at our law firm is an experienced team of trial lawyers that focus exclusively on the representation of plaintiffs in Depakote lawsuits. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.

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