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Depakote Lawsuit Information

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Birth Defects Linked To Depakote

Taking Depakote has been linked to harmful effects on the liver and to serious birth defects. If you, your child, or anyone you know have taken the drug and experienced the serious side effects associated you may be entitled to significant compensatio and should share your story with our Depakote birth defect attorney now.

Our experienced drug injury lawyer will be able to answer your lawsuit questions, with no obligation, and present your legal options if your infant child suffered:

  • Cleft palates
  • Spina bifida
  • Hand malformations
  • Undescended testes
  • Hypospadia (a condition in which the opening of the urethra in male babies is not correctly positioned)
  • Abnormally developed ribs
  • Potential fetal death

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Prenatal Depakote Use Harmed My Child?

The drug Depakote (divalproex sodium) was designed and prescribed for treatment of bipolar disorder and epilepsy. It treats the manic phase in bipolar disorder as well as working as an anti seizure treatment. More recently it has also been used to treat the depressive episodes of bipolar disorder and as a treatment for migraine headaches.

The drug was brought to market by Abbot Laboratories in 1983. Since then their patent has expired and the drug is now available as generic divalproex sodium manufactured by several generic drug manufacturers including Teva Pharmaceuticals, Sandoz Labs, Lupin Pharmaceuticals, Mylan and Sun Pharmaceutical Industries.

Depakote Linked to Birth Defects

Depakote has been the subject of controversy for over a decade due to its potentially life threatening side effects. A depakote class action was filed to address a number of complication allegations. It was shown to cause liver damage in certain patients, and in 2000 the FDA required Abbot to include a black box warning regarding potential liver damage risks. Even more troubling was the finding that Depakote use in pregnant women increased the risk of certain types of birth defects.

In 2007, the FDA required additional black box warnings to advise users of potential birth defects to infants who are exposed to Depakote during gestation. The drug has since been classified as a “Category C” drug for pregnant women. A number of Depakote lawsuits have been filed alleging child injuries, and birth defect attorneys continue to review claims. This classification is for drugs that have been shown to have adverse effects in animal studies; however there have been no controlled studies in pregnant women.

Data has been put forward by the North American Antiepileptic Drug Pregnancy Registry showing that 1g/day of divalproex sodium during the first trimester increases the risk of congenital malformations by 4x in comparison with alternative antiepileptic treatments.

The most concerning birth defect associated with the use of Depakote by pregnant women is spina bifida. This is when the embryonic neural tube is either malformed or incompletely formed. As a result, the infant is born with an incomplete spinal formation, causing the spinal cord to be exposed. The risk of this malformation in the general population is just 0.14 to 0.20%, however, women who use Depakote during pregnancy have a risk between 1-2% of having an infant born with spina bifida. While this may still be considered a small percentage, it is 5-10 times the risk of the general population which is significant.

Additional Side Effects of Taking Depakote

In addition to the liver damage known to be caused by Depakote usage, there are a number of possible side effects that can affect an unborn fetus. Any woman who is pregnant, nursing, or planning to get pregnant should avoid the use of Depakote due to the following risks to their unborn baby:

  • Cleft palates
  • Spina bifida
  • Hand malformations
  • Undescended testes
  • Hypospadia (a condition in which the opening of the urethra in male babies is not correctly positioned)
  • Abnormally developed ribs
  • Potential fetal death

If you or your children have experienced any of the side effects connected with its use, contact our drug injury lawyers immediately to discuss your legal options and answer your questions about a potential Depakote lawsuit. A successful compensation law suit may entitle you to significant financial recovery that can help with medical and financial burdens faced.


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McDonald Worley Attorneys At Law
1770 St. James Place, Suite 100 |  Houston, Texas 77056
 | Toll Free Phone: (800) 610-2001 | Phone: (713) 523-5500
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