Abbott’s popular anti-epileptic drug Depakote was originally developed to treat seizures and episodes of mania for those diagnosed with bipolar disorder. While the drug has demonstrated considerable effectiveness in treating some ailments and disorders, Depakote has also been linked to birth defects including brain problems, cranial abnormalities, and spina bifida. If you or someone you love gave birth to a child with birth defects after taking Depakote during pregnancy, you may have a legal case against Abbott to recover compensation.
Depakote Birth Defects Lawsuit Review: If you or somebody you know has a child that has been diagnosed with a birth defect related to Depakote, 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 Depakote?
Anti-epileptic medications such as Depakote are critical to the quality of life for millions of Americans who suffer from seizures, bipolar disorders and migraine headaches. Depakote 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 Depakote birth defects began to surface.
Sadly, a large number of women who took Depakote during pregnancy have given birth to babies with severe birth defects. The U.S. Food & Drug Administration (FDA) has released warnings regarding the link between Depakote and the following congenital birth defects:
- Neural tube birth defects
- Craniofacial defects
- Cleft lip
- Cleft Palate
- Spina bifida
- Aortic stenosis
- Cardiovascular malformations
- Cognitive impairment
- Valproate syndrome
- Limb and skeletal defects
- Growth retardation
- Hand deformations
- Fetal death
Depakote Medical Studies
A 2001 study published in the New England Journal of Medicine (NEJM) found that anti-epileptic drugs like Depakote are one of the most common causes of potential harm to an unborn baby. The study found that babies born to women who took anticonvulsant drugs containing valproate were significantly more likely to be born with serious congenital defects compared to infants not exposed to such medications in utero. These abnormalities affected more than 20% of children whose mothers took one anti-epileptic medication during pregnancy and nearly 30% of babies who were exposed to more than one such drug, compared to a mere 8.5% of infants who were not exposed to any epilepsy drugs in the womb.
Despite these shocking statistics, Depakote is still on the market and is used by nearly 2.5 million people each and every year around the country. Depakote 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 ever since.
FDA Warning on Depakote
The FDA has issued a press release warning the public that Depakote is a major teratogen, and that it may expose unborn babies to a drastically increased risk of neural tube defects. According to the administration’s warning:
“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… The rates for neural tube defects in babies exposed to valproate during the first trimester are 30 to 80 times higher than the rate for neural tube defects in the general U.S. population.’’
In April 2009, the FDA required Abbott to update Depakote’s warning label to include new information regarding the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The registry was initiated to analyze the safety of prescription drug like Depakote when taken by pregnant women.
Depakote Black Box Warning
Since it was first approved by the FDA, Depakote has had an extensive history of revisions to labeling related to birth defects. As of 2009, the Depakote label contains a so-called ‘black box’ warning – the strictest allowed by law – regarding teratogenity:
TERATOGENICITY: VALPROATE CAN PRODUCE TERATOGENIC EFFECTS SUCH AS NEURAL TUBE DEFECTS(E.G., SPINA BIFIDA). ACCORDINGLY, THE USE OF DEPAKOTE TABLETS IN WOMEN OF CHILDBEARING POTENTIAL REQUIRES THAT THE BENEFITS OF ITS USE BE WEIGHED AGAINST THE RISK OF INJURY TO THE FETUS. THIS IS ESPECIALLY IMPORTANT WHEN THE TREATMENT OF A SPONTANEOUSLY REVERSIBLE CONDITION NOT ORDINARILY ASSOCIATED WITH PERMANENT INJURY OR RISK OF DEATH (E.G., MIGRAINE) IS CONTEMPLATED. SEE WARNINGS, INFORMATION FOR PATIENTS. A PATIENT INFORMATION LEAFLET DESCRIBING THE TERATOGENIC POTENTIAL OF VALPROATE IS AVAILABLE FOR PATIENTS.
The latest warning was based the results of several studies that confirmed the link between Depakote 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 NEJM 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.
Do You Have a Depakote Lawsuit?
If you took Depakote while you were pregnant and your child has suffered any negative side effects as a result, you should consider filing a Depakote birth defects lawsuit as soon as possible. Your child’s health problems may have been caused by Depakote, and you may have legal grounds to pursue a lawsuit for injuries and damages. Our experienced Depakote birth defects lawyers can investigate the details of your case to determine the best course of action and will fight on your behalf for the compensation you deserve.
Is there a time limit in filing a Depakote birth defects lawsuit?
Although we encourage all our potential clients to take great care in selecting their Depakote 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 Depakote birth defects lawsuit and look forward to speaking with you.
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