Divalproex sodium – the active ingredient contained in Depakote, Depakote CR and Depakote ER – has been linked to an increased risk of severe birth defects and impaired cognitive development in children exposed to the drugs in utero. The FDA has issued a safety alert regarding the matter, and is recommending that both doctors and patients weigh the risks vs. benefits of divalproex sodium before deciding whether to take the medication.
Divalproex Sodium Birth Defects Update 5/7/13: Expecting mothers should avoid using valproate sodium and related drugs to prevent migraine headaches during pregnancy, according to a warning issued this week by the U.S. Food & Drug Administration (FDA). These medications, which include valproate sodium (Depacon), divalproex sodium (Depakote), valproic acid (Depakene and Stavzor), and all generic equivalents, have recently been linked to lower IQ scores in children exposed in the womb. Click here to learn more.
Free Divalproex Sodium Case Evaluation: If you or a loved one has given birth to a child with a congenital defect you feel may have been caused by divalproex sodium, 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?
Anti-epileptic medications such as divalproex sodium – the generic form of Depakote – are critical to the quality of life for millions of Americans who suffer from seizures, bipolar disorders and migraine headaches. Divalproex sodium helps to minimize the symptoms associated with these conditions, and can actually prevent seizures in certain circumstances. Unfortunately, as anticonvulsant drug use became more prevalent around the country, reports of divalproex sodium side effects began to surface.
FDA Warning on Divalproex Sodium
On June 30, 2011, the U.S. Food & Drug Administration (FDA) issued a press release notifying the public and medical communities that anticonvulsant valproate products had been associated with a large number of low cognitive test scores in children born to mothers who took the drugs during pregnancy. Medications indicated in the new warning include:
- valproate sodium (Depacon)
- divalproex sodium (Depakote, Depakote CP, Depakote ER)
- valproic acid (Depakene and Stavzor)
- generic versions of these medications
According to the administration, the new safety alert is “… based on the results of epidemiologic studies that show that children born to mothers who took valproate sodium or related products throughout their pregnancy tend to score lower on cognitive tests (IQ and other tests) than children born to mothers who took other anti-seizure medications during pregnancy.”
FDA is advising healthcare professionals to inform users about these risks, and to weigh the risks vs. benefits of taking divalproex sodium when prescribing it to women of childbearing age, especially when treating a condition not usually associated with permanent injury or death. Alternative courses of treatment containing fewer risks should be considered. If you are currently taking divalproex sodium or other related drug containing valproate, do not stop doing so without consulting your doctor first. Stopping these medications suddenly can cause serious problems to the user.
Side Effects of Divalproex Sodium
Mounting evidence and numerous case studies have linked the side effects of divalproex sodium to an increased risk of birth defects when taken as early as the first trimester of pregnancy, a time when many women may not even be aware they are pregnant). Congenital defects linked to divalproex sodium include:
- Neural tube defects
- Spina Bifida
- Cleft Palate
- Facial Dysmorphism
- Congenital cardiac defects
- Limb reduction and / or other skeletal anomalies
Divalproex Sodium Studies
Back in 2001, a study published in the New England Journal of Medicine (NEJM) indicated that anti-seizure medications like divalproex sodium are one of the most common causes of potential harm to a human fetus. The research found that children born to mothers who took anticonvulsant drugs containing valproate were significantly more likely to be born with major birth defects compared to infants not exposed to the medicines in the womb. These congenital defects affected approximately 21 percent of children whose mothers took one anti-epileptic medication during pregnancy and nearly 30 percent of babies who were exposed to more than one such drug, compared to a mere 8.5 percent of infants who were not exposed to any epilepsy drugs in the womb.
Despite these shocking statistics, divalproex sodium is still on the market in the form of Depakote, and is used by nearly 2.5 million people each year in the United States alone. Depakote is manufactured by Abbott Laboratories, and is available in a variety of forms including delayed and extended-release tablets, sprinkle capsules, Depakene capsules and syrup. Divalproex sodium was first approved by the FDA in 1983, and has been widely prescribed by physicians in the years since.
Our defective drug lawyers are helping victims nationwide by investigating potential divalproex sodium side effects lawsuits. We represent every client on a contingent fee basis, which means there are absolutely no legal costs or fees unless you recover money. Call us at (866) 588-0600 for a free case review today.
Do I have a Divalproex Sodium 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 divalproex sodium lawsuits. We are handling individual litigation nationwide and currently accepting new birth defects cases in all 50 states.