Valproate Lawsuit

Anti-seizure medications containing Valproate have been linked to an increased risk of lower cognitive test scores in children born to mothers who took the drugs during pregnancy. Valproate products include Depakote, Depacon, Depakene, Stavzor and their generics. Doctors and patients are strongly advised to weigh the risks vs. benefits of taking Valproate closely before beginning a regiment.

Free Valproate Case Evaluation: If your child or other loved one was born with a birth defect you feel may have been caused by a Valproate medication, 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 – The U.S. Food & Drug Administration (FDA) today issued a press release notifying the public and medical communities that a variety of valproate products – valproate sodium, valproate acid and divalproex sodium – have been linked to impaired cognitive development in children exposed to the medications in utero. The new warning is based on the results of epidemiological studies which concluded that children born to mothers who took valproate while pregnant tend to score lower on IQ and other cognitive tests than children born to mothers who took other types of anti-seizure medications during pregnancy.

In its press release, the FDA recommended that “Healthcare professionals should inform women of childbearing age of the increased risk for adverse effects on cognitive development with prenatal valproate exposure, and should continue to counsel women of childbearing potential taking valproate about the increased risk of major malformations, including neural tube defects, when valproate is used during pregnancy. In addition, healthcare professionals should weigh the benefits and risks of valproate when prescribing this drug to women of childbearing age, particularly when treating a condition not usually associated with permanent injury or death. Alternative medications that have a lower risk of adverse birth outcomes should be considered.”

Valproate Background

Valproate drugs are FDA-approved medications designed to treat seizures, the symptoms of bipolar disorder, and to prevent migraine headaches. Though they are not approved for such uses, valproate drugs are also commonly prescribed in an ‘off-label’ capacity to treat a variety of other psychiatric conditions. Off-label use is the practice of prescribing drugs for an unapproved indication or in an unapproved age group, unapproved dose or unapproved form of administration. Valproate products include the following:

valproate sodium (Depacon)
divalproex sodium (Depakote, Depakote CP, Depakote ER)
valproic acid (Depakene and Stavzor)
generic versions of these medications

Valproate Birth Defects

As with any medication, side effects are possible with valproate. As a treatment for seizures and migraine headaches, valproate products were once widely prescribed without warnings to pregnant women, until it was discovered that there was a significant risk of birth defects including (but not limited to):

Neural tube defects
Anencephaly
Encephaloceles
Hydranencephaly
Iniencephaly
Spina Bifida
Cleft Palate
Facial Dysmorphism
Congenital cardiac defects
Limb reduction and / or other skeletal anomalies

Depakote FDA Black Box Warning

In October 2006, the FDA required that Depakote and other valproate drugs carry a ‘black box’ warning – the strictest allowed by law – after the results of several studies confirmed the link between the medications and congenital birth defects. The following is an overview of each study:

American Academy of Neurology and American Epilepsy Society – found that pregnant women should avoid taking Depakote 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 in the journal 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 defects 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 similar medications.

In December 2009, the FDA notified healthcare professionals and patients about the increased risk of major birth defects in babies exposed to Depakote and other valproic drugs in utero. According to the warning, “There is an increased risk of neural tube defects, such as defects of the brain and spinal cord, and other major birth defects, such as craniofacial defects (abnormally formed face and skull enclosing the brain) and cardiovascular malformations (abnormally formed heart or blood vessels), in babies exposed to valproate sodium and related products during pregnancy.”

If you are pregnant or become pregnant while taking any variety of valproate drug, you should contact your healthcare provider immediately. Next, contact our law firm to speak with an experienced valproate birth defects lawyer who will evaluate your potential case at no charge. We will analyze your case and advise you to as to whether you may be entitled to compensation by filing a lawsuit.

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.