Depakote Lawsuit Information

Our law firm has successfully represented dozens of children who suffered birth defects in both state and federal court. We are currently accepting legal claims for children with spina bifida who were exposed to Depakote in utero.  We may be able to help your child recover compensation through a depakote lawsuit. Children with spina bifida have a lifetime of special needs. Compensation available through a depakote lawsuit may include recovery for past and future medical expenses, including both hospital and out-patient needs, as well as pain and suffering.

If your child has spina bifida and was exposed to depakote in utero, please contact us toll-free at 1-888-552-5247 for a free consultation regarding a depakote lawsuit. It is not too late to get your child the help he or she needs.

If we do not make a recovery for your child, you owe nothing.

Depakote and Spina Bifida

Depakote is a drug indicated in the treatment of bipolar mania. The FDA has warned that Depakote is a major teratogen. In particular, exposure to depakote drastically increases the risk of neural tube defects such as spina bifida.  According to the FDA:

“The risk of neural tube defects is much higher in babies born to mothers treated with valproate during the first 12 weeks of pregnancy, with the risk increasing to 1 in 20 babies… 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.”

The FDA also released this video to alert consumers to the risk of birth defects associated with Depakote and Depakote ER (extended release):

Depakote Birth Defect Registry

In April of 2009, the FDA asked the manufacturer of Depakote, Abbott Laboratories, to add information regarding the North American Antiepileptic Drug (NAAED) Pregnancy Registry to the drug label.  The Antiepileptic Drug Pregnancy Registry at Massachusetts General Hospital is designed to investigate the safety of drugs like Depakote when taken during pregnancy.  The success of pregnancy registries depends upon consumers being aware of the ability to report pregnancy exposures to the registry.  We strongly encourage all women exposed to antiepileptic drugs during pregnancy to file a report with the registry by calling toll-free 1-888-233-2334.

Depakote Black-Box Birth Defect Warning

Depakote was originally approved in 1978 for the treatment of epilepsy.  Approvals for similar drugs followed for Depakote CP, Depakote ER, Depakene, Depacon, and Stavzor.  Recently Depakote has been prescribed for less serious conditions such as migraine headache. Depakote has an extensive history of revisions to labeling related to birth defects and suicidality.  As of 2009 the Depakote label contains a “black box” warning regarding teratogenity:

TERATOGENICITY:  VALPROATE CAN PRODUCE TERATOGENIC EFFECTS SUCH AS NEURAL TUBE DEFECTS(E.G., SPINA BIFIDA). ACCORDINGLY, THE USE OF DEPAKOTE TABLETS IN WOMEN OF CHILDBEARING POTENTIAL REQUIRES THAT THE BENEFITS OF ITS USE BE WEIGHED AGAINST THE RISK OF INJURY TO THE FETUS. THIS IS ESPECIALLY IMPORTANT WHEN THE TREATMENT OF A SPONTANEOUSLY REVERSIBLE CONDITION NOT ORDINARILY ASSOCIATED WITH PERMANENT INJURY OR RISK OF DEATH (E.G., MIGRAINE) IS CONTEMPLATED. SEE WARNINGS, INFORMATION FOR PATIENTS. A PATIENT INFORMATION LEAFLET DESCRIBING THE TERATOGENIC POTENTIAL OF VALPROATE IS AVAILABLE FOR PATIENTS.

A black-box warning is the most serious type of warning that can placed on a drug label.

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