Depakene (generic: valproic acid) belongs to a group of drugs known to the FDA as valproate products. These products are used to treat seizures, migraine headaches and episodes associated with bipolar disorder. However, the FDA is advising women who are pregnant or of childbearing age to avoid the drugs as they may cause serious birth defects in children born to women who take them during pregnancy. Most seriously, they may cause neural tube defects in infants, which can cause conditions like spina bifida.
Depakene Birth Defects Lawsuit Review: If you or somebody you know has a child that has been diagnosed with a birth defect related to Depakene, 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 Depakene?
The FDA reports Depakene and other valproate drugs have been linked to the following 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
The FDA first approved Depakene (valproic acid) on February 28, 1978 for the treatment of epilepsy-related seizures. More recently, the FDA approved Depakene for the treatment of bipolar disorder and migraine headaches.
Depakene is manufactured by Abbott Laboratories and belongs to a group of drugs known as fatty acid derivative anticonvulsants, or valproate drug products. Other drugs that belong to this group include Depakote (divalproex sodium), Depacon (valproic acid) and Stavzor (valproic acid). These drugs affect chemicals in the body that are involved in causing seizures.
Yet, the FDA advises women who may be pregnant or thinking of becoming pregnant to avoid the drugs.
Depakene and other valproate treatments increase the risk of major malformations in babies born to mothers who take the anticonvulsant drug during pregnancy. Recent research from the North American Antiepileptic Drug (NAAED) Pregnancy Registry suggests the rate of major malformations in babies born to women with epilepsy taking Depakene or other valproate therapies is almost 4 times higher than the rate of major malformations in babies born to women taking different antiepileptic drugs. Most seriously, these malformations may include neural tube defects. On average, 1 in 1500 babies is born with a neural tube defect in the United States. With Depakene treatment, this risk increases to 1 in 20 babies.
Depakene is classified as a Category D drug by the FDA, meaning there is strong evidence from both animal and human studies that a human fetus is at risk of birth defects.
Due to the severity of the birth defects associated with Depakene, you or somebody you know may want to contact a lawyer or attorney at our firm to discuss the potential of a Depakene birth defects lawsuit.
On December 3, 2009, the FDA issued information to health care professions that Depakene and other valproate products were linked to an increased risk of neural tube defects and other major birth defects — including craniofacial defects and cardiovascular malformations — in babies born to mothers who took the drugs during pregnancy.
While an average of 1 in 1500 babies are born with neural tube defects in the US, the risk is much higher in babies born to mothers treated with Depakene or other valproate products during the first 12 weeks of pregnancy — the risk increases to 1 in 20 babies.
This is in addition to data from the NAAED Pregnancy Registry that suggests babies born to mothers who took valproate products like Depakene during pregnancy had a 4 times higher risk of major malformations than babies born to mothers who used different antiepileptic drugs. The NAAED Registry found a major malformation rate of 10.7%, compared to 2.9%.
On June 30, 2011, the FDA released a Drug Safety Communication informing the public that children born to mothers who took valproate anti-seizure medications during pregnancy had an increased risk of lower cognitive test scores than children exposed to other anti-seizure medications during pregnancy.
Cognitive tests are often performed on children to assess development in areas such as intelligence, abstract reasoning and problem solving.
The FDA cited a study where children born to mothers who used Depakene or valproate throughout their pregnancy scored lower on cognitive tests, such as an IQ test. These results were observed in children as young as three years old.
Other Valproate Products
Valproate products are drugs 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)
- Depakene (valproic acid)
- Stavzor (valproic acid)
In light of the birth defects associated with Depakene, the FDA recommends that:
The benefits and the risks of valproate sodium and related products [including valproic acid] should be carefully weighted when prescribing these drugs to women of childbearing age, particularly for conditions not usually associated with permanent injury or death. If the use of valproate is not essential, alternative medications that have lower risk to the fetus of birth defects and adverse cognitive effects should be considered in pregnant women and women of childbearing age. If the decision is made to use valproate in women of childbearing age, effective birth control should be used.
Is there a time limit in filing a Depakene birth defects lawsuit?
Although we encourage all our potential clients to take great care in selecting their Depakene 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 Depakene birth defects lawsuit and look forward to speaking with you.
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