Valproic acid and other similar anti-seizure medications have recently been linked by the FDA to major birth defects that include neural tube defects, craniofacial defects and cardiovascular malformations. More recently, the FDA suggested babies born to mothers who use valproic acid throughout pregnancy have lower cognitive development compared to other children.
Valproic Acid Birth Defects Lawsuit Review: If you or somebody you know has a child that has been diagnosed with a birth defect related to valproic acid, 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) 223-3784.
What Birth Defects Are Linked to Valproic Acid?
Valproic acid and other valproate products have been linked to serious and life-threatening side effects including:
- Neural tube defects (i.e. spina bifida, absence of parts of the brain)
- Craniofacial defects (i.e. cleft clip, cleft palate)
- Cardiovascular malformations (structural defects in the heart)
More recent studies by the FDA have suggested valproate products cause exposed children to have:
- Low cognitive development
Valproic Acid Overview
On December 3, 2009, the FDA issued information to healthcare professionals, advising them about the increased risk of neural tube defects and other major birth defects — such as craniofacial defects and cardiovascular malformations — in babies exposed to valproate sodium and related products (including valproic acid) during pregnancy. Valproic acid, commonly marketed as Depakene and Stavzor, belongs to a group of drugs known as fatty acid derivative anticonvulsants, or valproate drug products. These products affect chemicals in the body that can cause seizures.
Manufactured by Abbot Laboratories, the first valproate product approved by the FDA to treat seizures was Depakene (valproic acid) in February 1978. Stavzor was approved in July 2008 and is manufactured by Noven Therapeutics, LLC, but generic versions of the drugs are also available. Valproate drugs have since been approved for migraine prevention and to treat manic episodes associated with bipolar disorder.
Yet, the FDA is warning healthcare professionals that they should speak with female patients of childbearing potential about the risks of birth defects associated with valproic acid. These patients should consider alternative therapies, the FDA says, especially if using valproate to treat migraines or other conditions that are not considered life-threatening.
Additionally, the FDA released further information in June 2011 suggesting valproic acid and other related products may increase the risk of impaired cognitive development in children exposed to the anti-seizure medication during pregnancy.
Due to the severity of birth defects associated with valproic acid use, you or someone you know may want to contact a valproic acid lawyer or attorney with our firm to discuss the potential for a valproic acid lawsuit.
FDA Warnings on Valproic Acid Use
On December 3, 2009, the FDA issued a statement directed towards healthcare professionals, asking them to discuss the risks of birth defects associated with valproic acid use with women who may be of childbearing potential.
Said the FDA:
“The FDA is reminding health care professionals about the increased risk of neural tube defects and other major birth defects, such as craniofacial defects and cardiovascular malformations, in babies exposed to valproate sodium and related products (valproic acid and divalproex sodium) during pregnancy.”
According to the FDA, 1 in 1500 babies is born with a neural tube defect in the United States. If exposed to valproate during the first 12 weeks of pregnancy, this risk increases to 1 in 20 babies.
Additionally, information from the North American Antiepileptic Drug (NAAED) Pregnancy Registry shows the rate of major malformations in babies born to women with epilepsy taking valproate is almost 4 times higher than the rate of major malformations in babies born to mothers taking different anti-epileptic drugs. This equates to a major malformation rate of 10.7% in babies exposed to valproic acid during pregnancy, versus 2.9% in babies exposed to other anti-epileptic drug therapy.
Sixteen major malformations — including neural tube defects, craniofacial defects, cardiovascular malformations and malformations involving other body systems — occurred in offspring of 149 women.
Valproic Acid and Impaired Cognitive Development
In a June 30, 2011 Drug Safety Communication, the FDA advised the public that children born to mothers who took the anti-seizure medication valproic acid or related products during pregnancy had an increased risk of lower cognitive test scores than children exposed to other anti-seizure medications during pregnancy.
These children tend to score lower on IQ tests and other cognitive tests. These tests commonly assess development in a variety of areas, including intelligence, abstract reasoning and problem solving.
Several published studies indicate children exposed to valproate during pregnancy have lower cognitive test scores than children exposed to a different anti-seizure medication or no anti-epileptic drugs at all. One large study conducted in the US and the UK found children with valproate exposure throughout pregnancy had lower cognitive test scores at age 3 than children with exposure to the anti-epileptic drugs lamotrigine or carbamazepine.
Other Valproate Products
Valproate products are drugs FDA-approved to treat seizures, manic or mixed episodes associated with bipolar disorder, and migraine headaches.
Valproate products include:
- Depacon (valproate sodium)
- Depakote (divalproex sodium)
- Depakene (valproic acid)
- Stavzor (valproic acid)
- Generics
Is there a time limit in filing a valproic acid birth defects lawsuit?
Although we encourage all our potential clients to take great care in selecting their valproic acid 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) 223-3784.
We hope we will be able to assist you with your potential valproic acid birth defects lawsuit and look forward to speaking with you.
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