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Depacon / Depakene / Depakote Lawsuit Information

Valproic Acid (Depacon) and Birth Defects Lawsuit Information

Maternal use of valproic acid (the active ingredient in Depacon Depakene, and Depakote) during pregnancy has recently been associated with an increased risk for birth defects and autism, including craniofacial, cardiovascular, and neurological malformations.

In 2008, valproic acid (also “divalproex sodium,” “valproate sodium”) was cleared by the FDA for the treatment of epilepsy, a condition as of 2012 affecting 50 million people worldwide, including over 2 million Americans (about 1 in 26).

Since its original release, the FDA has issued several warnings regarding the relationship between Depacon use during pregnancy and negative fetal outcomes.

Though the value of this drug is well-established by its effectiveness in the treatment of epilepsy, its association with negative fetal outcomes ought to be considered in its administration to pregnant women.

Valproic acid (Depacon / Depakene / Depakote) and Birth Defects

There are three main types of birth defects associated with valproic acid (Depacon): craniofacial birth defects, cardiovascular birth defects, and MayoClinic.  Autism Spectrum Disorder is also associated with maternal use of Depacon / Depakene / Depakote during pregnancy.

Craniofacial Birth Defects and Valproic Acid (Depacon / Depakene / Depakote):

In 1989, a team of Scandinavian researchers led by ML Friis published a report in ‎Acta Neurologica Scandinavica demonstrating that maternal use of antiepileptic drugs (AEDs) during pregnancy dramatically raised the risk of giving birth to a child with facial clefts or congenital heart defects (CHD).

An excerpt from the abstract of the 1989 ‎Acta Neurologica Scandinavica article:

“Our data suggest that genetic factors are of minor importance for the etiology of facial clefts in offspring of epileptic patients. The rate of facial clefts was increased by a factor of 4.7 in children of AED-treated mothers with epilepsy compared with the background population values.”

MayoClinic defines craniofacial disorders as such: Craniofacial disorders are abnormalities of the face or head, caused by a birth defect, disease or trauma.

  • Abnormal skull shapes due to premature closure of joints called head sutures (craniosynostosis), such as a forehead with one side flattened (plagiocephaly), a long and narrow skull (scaphocephaly) or a pointed forehead (trigoncephaly)

  • Hypertelorism — eyes that are abnormally far apart

  • Hypotelorism — eyes that are abnormally close together

  • Apert syndrome — abnormal skull shape, small upper jaw, abnormal distance between eyes, fused fingers and toes

  • Crouzon syndrome — abnormal skull shape, abnormal distance between eyes, protruding eyeballs, underdeveloped upper jaw

  • Cleft lip, cleft palate and facial clefts

  • Treacher Collins syndrome — underdeveloped cheekbones and lower jaw

  • Hemifacial microsomia — asymmetry of one or both sides of the face with missing or underdeveloped bones on the affected side

  • Diseases such as neurofibromatosis or malignancies

Cardiovascular Birth Defects and Valproic Acid (Depacon / Depakene / Depakote):

MayoClinic on cardiovascular birth defects: Heart defects usually develop while a baby is still in the womb. About a month after conception, the heart begins to develop. It’s at this point that heart defects can begin to form. Some medical conditions, medications and genes may play a role in causing heart defects.

In addition to the 1989 article described above demonstrating the association between maternal use of Depacon / Depakene / Depakote during pregnancy and congenital malformation of the heart, a team of researchers led by L. Etemad also concluded that “The incidence of major malformations in offspring of mothers with epilepsy who were treated with AEDs is higher than women with untreated epilepsy and in the general population. These malformations include spina bifida, cleft palate, limb reduction defects, cardiac abnormalities, hypospadias, and gastrointestinal atresia.”

The full text of this second article published in Journal of Research in Medical Scienes, showing the connection between epilepsy medicine and cardiovascular birth defects, among others, is available by following the link above, provided by

Here is an excerpt from MedlinePlus, a medical encyclopedia curated by the National Library of Medicine and the National Institutes of Health, where a great deal of clear information is available regarding congenital heart malformation.

Congenital heart disease (CHD) can describe a number of different problems affecting the heart. It is the most common type of birth defect. Congenital heart disease causes more deaths in the first year of life than any other birth defects.

Congenital heart disease is often divided into two types: cyanotic (blue skin color caused by a lack of oxygen) and non-cyanotic. The following lists cover the most common congenital heart diseases:

Cyanotic:

Non-cyanotic:

These problems may occur alone or together. Most children with congenital heart disease do not have other types of birth defects. However, heart defects can be part of genetic and chromosome syndromes. Some of these syndromes may be passed down through families.

Examples include:

Often, no cause for the heart disease can be found. Congenital heart diseases continue to be investigated and researched. Drugs such as retinoic acid for acne, chemicals, alcohol, and infections (such as rubella) during pregnancy can contribute to some congenital heart problems.

Poorly controlled blood sugar in women who have diabetes during pregnancy has also been linked to a high rate of congenital heart defects.

Symptoms

Symptoms depend on the condition. Although congenital heart disease is present at birth, the symptoms may not appear right away.

Defects such as coarctation of the aorta may not cause problems for many years. Other problems, such as a small ventricular septal defect (VSD), may never cause any problems. Some people with a VSD have a normal activity level and lifespan.

Exams and Tests

Most congenital heart defects are found during a pregnancy ultrasound. When a defect is found, a pediatric heart doctor, surgeon, and other specialists can be there when the baby is delivered. Having medical care ready at the delivery can mean the difference between life and death for some babies.

Which tests are done on the baby depend on the defect, and the symptoms.

Treatment

Which treatment is used, and how well the baby responds to it, depends on the condition. Many defects need to be followed carefully. Some will heal over time, while others will need to be treated.

Some congenital heart diseases can be treated with medication alone. Others need to be treated with one or more heart surgeries.

Neurological Birth Defects and Valproic Acid (Depacon / Depakene / Depakote):

Neurological birth defects have also been associated with maternal use of valproic acid.  Research by C. Cummings et al. published in a 2011 edition of Archives of Diseases in Childhood has shown that maternal use of valproic acid (Depacon, Depakene, Depakote) makes children over 26 times more likely to be born with a neurological defect, as compared to the risk of neurological birth defects associated with other widely-used epilepsy medications, such as lamotrigine (Lamictal) and carbamazepine (Tegretol, Equetro, Epitol).

Though the cohort in that study was small, other research teams have found correlations between maternal use of valproic acid and neurological birth defects, such as spina bifida.

In fact, a study published by SM Gibosa, et al. in a 2011 edition of American Journal of Medical Genetics has determined that use of valproic acid (Depacon) during pregnancy raises the risk that one’s child will be born with spina bifida by a factor of 11.9.

Here are some places where you can find more information on spina bifida and neurological birth defects.

Autism Spectrum Disorder (ASD) and Valproic Acid (Depacon / Depakene / Depakote):

Contemporary research has also found a connection between maternal use of valproic acid during pregnancy and Autism Spectrum Disorder (ASD).

One such publication, by Jakob Christensen, PhD et al. (2013) in Journal of the American Medical Association titled “Prenatal Valproate Exposure and Risk of Autism Spectrum Disorders and Childhood Autism” has found that children born to mothers who used sodium valproate during pregnancy were 70% as likely to be born with Autism Spectrum Disorder than children born to mothers who used other epilepsy drugs during pregnancy.

Depacon / Depakene / Depakote Lawsuits

Fetal malformations can be a highly serious side-effect of Depacon, Depakene, and Depakote use.  Though the manufacturer of Depacon, Depakene, and Depakote – AbbVie, Inc. (formerly Abbott Laboratories)  – suggests that birth defects caused by these drugs are rare, scholarly research such as that cited above seems to suggest otherwise.  As a result, a very large class-action Depacon lawsuit is currently underway in the United Kingdom.

As is always the case, the manufacturer of Depacon, Depakene, and Depakote, is legally obligated to make clear warnings about all complications associated with the use of its products, and advise users about the likelihood that those complications should occur.  Any withholding of information from the consumer or misleading of the customer by the manufacturer is criminal, and when situations like this do occur, manufacturers must be held responsible for their actions or lack thereof.

Due to the emerging and increasingly-clear fact that the likelihood of serious complications such as craniofacial, cardiovascular, and neurological, and other birth defects occurring with Depacon / Depakene / Depakote use is significantly higher than is reported by AbbVie Laboratories, women who used Depacon / Depakene / Depakote and gave birth to a child with a congenital malformation may be eligible to file a Depacon birth defect lawsuit to gain compensation for undue injury to her newborn.

More Information on Depacon / Depakene / Depakote

If you have a question about Depacon, Depakene, or Depakote that isn’t answered here, feel free to give my office a call at (855) 452 – 5529 or e-mail me at justinian@dangerousdrugs.us.

Also, every post we’ve written about Depacon / Depakene / Depakote is available here.