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Valproate Sodium Linked to Birth Defects

On December 3, 2009 the U.S. Food & Drug Administration (FDA) notified healthcare professionals and patients taking Valporate Sodium and other related products that there have been an increased incidence of birth defects in babies born to mothers that took these drugs while pregnant.

Valproate sodium is marketed as Depacon. Dilvalproex sodium is marketed as Depakote, Depakote CP, Depakote ER. Valproic acid is marketed as Depakene and as Stavzor.

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.

If you or somebody you know has given birth to a child with birth defects and have taken any of the aformentioned drugs while pregnant or during the pregnancy, you should contact us immediately. You may be entitled to compensation and we can help.

What’s the problem?

FDA first approved Depakene (valproic acid) in 1978 for the treatment of epilepsy. More recently, FDA approved valproate for the treatment of bipolar disorder and migraine headaches. As valproate’s indications for use expand, it is critical that all health care professionals caring for women of childbearing potential and taking valproate for any indication be informed that valproate causes an increased risk of major birth defects. Awareness of the therapeutic benefits and risks of valproate and alternative therapies, as well as the risks of untreated disease, is critical for informed prescribing and counseling of all women taking valproate.

Valproate use during pregnancy increases the risk of major malformations, including neural tube defects. In the United States, about 1 in 1500 babies is born with a neural tube defect. The risk of neural tube defects is much higher in babies born to mothers treated with valproate during the first 12 weeks of pregnancy, with the risk increasing to 1 in 20 babies.

Data from the NAAED Pregnancy Registry show that the rate of major malformations in babies born to women with epilepsy taking valproate (monotherapy) is almost 4 times higher than the rate of major malformations in babies born to women with epilepsy taking a different antiepileptic drug. The NAAED Registry reported a major malformation rate of 10.7% (95% C.I. 6.3% – 16.9%) in the offspring of women exposed to an average of 1,000 mg/day of valproic acid monotherapy during pregnancy (dose range 500 – 2000 mg/day). The major malformation rate among the internal comparison group of 1,048 women with epilepsy who received any other antiepileptic drug monotherapy during pregnancy was 2.9% (95% CI 2.0% to 4.1%). Sixteen major malformations occurred in the offspring of 149 women who used valproate during pregnancy, and these malformations included neural tube defects, craniofacial defects, cardiovascular malformations and malformations involving other body systems.

Types of Birth Defects

The more common types of birth defects associated with these drugs are as follows:

  • neural tube defects
  • craniofacial defects
  • cardiovascular malformations
  • and other major birth defects

List of Drugs

The following is a list of drugs linked to the increased risk of birth defects in babies born to mothers that took them during their pregnancy.

  • Valporate Sodium
  • Valproic Acid
  • Divalproex Sodium
  • Depacon
  • Depakote
  • Depakote CP
  • Depakote ER
  • Depakene
  • Stavzor

Do I Have a Valproate Sodium 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 drug side effect lawsuits. We are currently evaluating potential Valporate Sodium birth defect claims in all 50 states.

Again, If you or somebody you know has given birth to a child with birth defects and have taken any of the aformentioned drugs while pregnant or during the pregnancy, you should contact us immediately. You may be entitled to compensation and we can help.

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