Stavzor (generic: valproic acid) and other valproate products have been prescribed since the 1970s to treat patients suffering from seizures, migraines, or manic episodes associated with bipolar disorder. Recently, the FDA is warning women who may be pregnant or of childbearing age to avoid the drugs, as they have been linked to serious birth defects in children who were born to mothers who took them during pregnancy. The most serious birth defects include neural tube defects, craniofacial defects and cardiovascular malformations.
Stavzor Birth Defects Lawsuit Review: If you or somebody you know has a child that has been diagnosed with a birth defect related to Stavzor, 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.
What Birth Defects are Linked to Stavzor?
The FDA reports Stavzor and other valproate drugs have been linked to sixteen major malformations associated with:
- 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)
Additionally, recent research suggests babies born to mothers who used Stavzor or other valproate drugs during pregnancy may have:
- Low cognitive development
Marketed and distributed by Noven Therapeutics, LLC, Stavzor (valproic acid) was approved by the FDA on July 29, 2008 for treating seizures associated with epilepsy, manic episodes associated with bipolar disorder, and migraine headaches.
It belongs to a group of drugs known as valproate products, or fatty acid derivative anticonvulsants. These medications affect naturally-occurring chemicals in the body that can cause seizures.
However, the FDA and the North American Antiepileptic Drug (NAAED) Pregnancy Registry have found evidence concluding babies born to mothers who take Stavzor, and drugs similar to it, may be at increased risks of developing major malformations or birth defects. These birth defects may include neural tube defects, craniofacial defects and cardiovascular malformations.
As a result, the FDA is encouraging women who are pregnant, may become pregnant, or are of childbearing age to avoid Stavzor and valproate products and pursue other anticonvulsant medications that have lower risks of birth defects.
Due to the severity of the birth defects associated with Stavzor, you or somebody you know may want to contact a lawyer or attorney at our firm to discuss the potential for a Stavzor birth defects lawsuit.
FDA and NAAED Studies and Warnings
On December 3, 2009, the FDA issued a statement directed towards healthcare professionals, reminding them of the birth defect risks associated with Stavzor and other valproate products. The FDA asked healthcare practitioners to inform women of childbearing potential about the increased risk of neural tube defects and other major birth defects.
On average, about 1 in 1500 babies are born with a neural tube defect in the United States. Yet, in babies born to women who took Stavzor during pregnancy, these risks jump to 1 in 20 babies, the FDA reports.
Additionally, the NAAED Pregnancy Registry found babies born to epileptic women who took valproate therapy during pregnancy develop major malformations at almost a 4 times higher rate than babies born to epileptic women who used a different antiepileptic drug. The NAAED reported a malformation rate of 10.7% in babies of valproate mothers, compared to 2.9% in babies born to mothers who used other antiepileptic drugs.
As the FDA announcement to the health care community stated:
“Valproate use during early pregnancy increases the risk of major malformations in the baby. 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 pregnant women with epilepsy, valproate monotherapy is associated with a four-fold higher rate of major malformations than other antiepileptic drug monotherapies.”
Furthermore, on June 30, 2011, the FDA released a Drug Safety Communication explaining pregnant mothers who received Stavzor therapy are more likely to give birth to children with lower cognitive skills, compared to children exposed to other anti-seizure medications during pregnancy.
These children scored lower on cognitive tests, which are often performed on children to assess development in areas such as intelligence, abstract reasoning and problem solving. They include assessments like IQ tests.
In particular, the FDA referenced a study where children born to mothers who used Stavzor or other valproate therapy through their pregnancy scored lower on cognitive tests. These results were observed in children as young as three years old.
Drugs Belonging to the Valproate Group
Valproate products are FDA-approved to treat seizures and manic or mixed episodes associated with bipolar disorder, and to prevent migraine headaches.
Valproate products include:
- Depacon (valproate sodium)
- Depakote (Divalproex Sodium)
- Stavzor (valproic acid)
Is there a time limit in filing a Stavzor birth defects lawsuit?
Although we encourage all our potential clients to take great care in selecting their Stavzor 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 Stavzor birth defects lawsuit and look forward to speaking with you.
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