Valproate sodium is the active ingredient used in many popular anticonvulsant medications such as Depakote, Depacon and Depakene. Unfortunately, recent studies have shown that valproate sodium may be the chief culprit behind many serious birth defects including cleft palate, spina bifida and atrial septal defects. If you took anticonvulsants containing valproate sodium during pregnancy and your child was born with any of these potentially life-threatening congenital defects, you may be entitled to compensation by filing a lawsuit and we can help.

Valproate Sodium Birth Defects Lawsuit Review:If you or somebody you know has a child that has been diagnosed with a birth defect related to valproate sodium, you should contact our lawyers immediately. Consultations are always free. Please use our confidential email contact form or call toll free 24 hrs/day by dialing (866) 588-0600.

Which birth defects have been linked to valproate sodium?

Despite the massive popularity of valproate sodium drugs in treating conditions like bipolar disorder, epilepsy, migraine headaches and seizures, the safety of these products has recently come under scrutiny. Recent studies have linked valproate sodium to severe birth defects in babies born to mothers who took the drug during pregnancy, and many experts believe that anticonvulsant drugs containing valproate sodium are one of the most common causes of harm to unborn children. The following is a list of birth defects that are currently being evaluated for potential valproate sodium lawsuits:

Generally speaking, the majority of these birth defects are thought to occur because the sodium in valproate drugs can lower the amount of folic acid present in the mother’s system. This lowering of folic acid can be extremely hazardous to a fetus, and many babies were born with severe birth defects as a result.

Unfortunately, many of the valproate sodium birth defects listed above can cause life-long pain and suffering for the child. Some of the complications that can arise from these injuries include impaired vision and hearing, bladder and bowel difficulties, as well as severely reduced cognitive and physical growth. Many of these congenital abnormalities will require costly long-term treatment, and some may even result in such extreme complications that the child will die shortly after being delivered.

Valproate Sodium Overview

Manufactured and marketed by Abbott Laboratories, valproate sodium is an FDA-approved prescription medication designed to treat seizures, bipolar disorder (manic-depressive disorders), and to prevent migraine headaches. Valproate sodium is also commonly prescribed in an ‘off-label’ capacity (for which it was neither tested nor approved by the FDA) for a number of other severe psychiatric conditions. Products containing valproate sodium include:

  • Depacon (valproate sodium)
  • Depakote, Depakote CP, & Depakote ER (divalproex sodium)
  • Depakene (valproic acid)
  • Stavzor (valproic acid)
  • Generic versions of these drugs

Valproate Sodium & Neural Tube Defects (NTDs)

NTDs are some of the most commonly reported birth defects found in babies exposed to valproate sodium in the womb. These congenital abnormalities are typically characterized by an opening in the spinal cord or brain that occurs during the first trimester of pregnancy, when specialized cells on the dorsal side of the fetus begin to fuse and form the neural tube. When the neural tube does not close completely, an NTD is the result. Common neural tube defects include anencephaly, encephaloceles, hydranencephaly, iniencephaly, and spina bifida.

Craniofacial Birth Defects

Craniofacial defects such as cleft lip and cleft palate are among the most commonly reported birth defects in the United States each year. They can be isolated or one component of an inherited disease or syndrome. Although craniofacial defects can be repaired to varying degrees with surgery, researchers are currently working to understand the developmental processes that lead to these anomalies in order to prevent and treat the conditions more effectively.

Craniofacial birth defects are a primary cause of infant mortality and have significant long-term consequences that are devastating to both children and their families. Surgical intervention, dental care, psychological counseling and rehabilitation can help lessen the effects of craniofacial anomalies, but at a great cost over many years. In fact, the Centers for Disease Control and Prevention (CDC) estimates that the lifetime cost of treating children born with craniofacial birth defects such as cleft lip and cleft palate to be nearly $700 million.

Valproate Sodium & Autism

In 2005, a study found that nearly 9% of children exposed to valproate sodium in utero were born with autism. The normal incidence for autism in the general public is typically less than 1%. Another study conducted in 2008 found a correlation between higher rates of autism in children whose mothers were treated with valproate sodium during pregnancy, 6.3% vs. less than 1% for children who did not receive the drug in utero. Taken in combination, these studies seem to indicate a definitive correlation between the use of valproate sodium in pregnant women and higher autism rates in their children.

FDA Warning on Valproate Sodium

In December 2009, the FDA issued a press release warning healthcare professionals and their patients about an increased risk of neural tube, craniofacial and cardiovascular birth defects in babies exposed to valproate sodium and related products (valproic acid and divalproex sodium) during pregnancy. The administration cautioned healthcare practitioners to inform female patients of childbearing age about these potential risks, and to consider alternative therapies, especially if taking valproate sodium to treat non life-threatening conditions. According to the warning:

“Women of childbearing potential should only use valproate if it is essential to manage their medical condition. Those who are not actively planning a pregnancy should use effective contraception, as birth defect risks are particularly high during the first trimester, before many women know they are pregnant.”

Is there a time limit in filing a valproate sodium birth defects lawsuit?

Although we encourage all our potential clients to take great care in selecting their valproate sodium birth defects lawyer, it is important that you understand that time is of the essence. The applicable statute of limitations in your state may time bar your claim. Furthermore, we are unable to provide you with legal advice without first evaluating your potential case. Accordingly, please take the time now to contact us by using the confidential email contact form below or by calling us toll free 24 hrs/day by dialing (866) 588-0600.

We hope we will be able to assist you with your potential valproate sodium birth defects lawsuit and look forward to speaking with you.


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