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FDA Alert: Valproate Linked to Cognitive Birth Defects

In response to the results of several convincing epidemiological studies, the U.S. Food & Drug Administration (FDA) is notifying healthcare professionals that children born to women who take valproate anti-seizure medications – Depakote, Depacon, Depakene or Stavzor – have an increased risk of lower I.Q. and other cognitive test scores than children born to mothers who took other types of anti-epileptic drugs. The new research seems to confirm numerous other studies linking valproate-containing medicines to a host of extremely serious side effects and birth defects.

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.

Free Valproate Case Evaluation: If you or a loved one has given birth to a child with any of the congenital defects listed in this article after taking a valproate drug during pregnancy, 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?

June 30, 2011 – Today’s FDA safety announcement is aimed at underlining the increased risk for lower cognitive test scores among children born to mothers taking valproate sodium, valproic acid and divalproex sodium during pregnancy relative to other epilepsy drugs. Valproate products are FDA-approved to treat seizures, bipolar disorder and migraine headaches, but are also commonly used ‘off-label’ to treat a variety of other psychiatric disorders.

“FDA has evaluated all available evidence to date, and will be adding information about the risk of lower cognitive test scores to the valproate product labels in the Warnings and Precautions section, the Use in Specific Populations: Pregnancy section, and to the Medication Guides that are being developed for the valproate drug products,” the alert notes.

In the primary study upon which the administration’s warning is based, cognitive test results were performed on children at age 3. In supportive studies, similar tests were performed between the ages of 5 and 16. Cognitive tests of this sort are typically used to analyze development in a variety of areas including intelligence, problem solving and abstract reasoning.

The long-term birth defect risk from exposure to valproate products is still largely unknown, and it is uncertain as to whether these effects occur when fetal exposure is limited to less than the full duration of pregnancy. “Although all of the available studies have methodological limitations, the weight of the evidence supports the conclusion that valproate exposure in utero causes subsequent adverse effects on cognitive development in offspring,” the FDA announcement concludes.

Valproate Birth Defects

In addition to the increased risk of lower cognitive test scores, valproate sodium and related products have recently been linked to the following catastrophic birth defects:

If You Are Taking Valproate

If you are taking or considering beginning a regiment of any brand of valproate medication, please take the following information into consideration:

  • You should never discontinue use of valproate without consulting a doctor, as stopping valproate suddenly can cause serious problems.
  • Women of childbearing age who are taking valproate drugs should be sure to use effective contraceptive methods while taking the medicine.
  • If you are pregnant or planning to become pregnant, talk to your healthcare professional before you start valproate. Your doctor may advise you to look into other treatment options.
  • If you become pregnant while taking valproate, consult your physician about registering with the North American Antiepileptic Drug Pregnancy Registry. The purpose of this registry is to collect information about the safety of epilepsy drugs during pregnancy.
  • Valproate may pass into breast milk, so talk to your doctor about the best way to feed your baby if you take valproate.
  • Report any side effects to the FDA MedWatch program.

Do I have a Valproate Lawsuit?

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

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