The Food and Drug Administration (FDA) issued a Depakote warning in 2009 regarding increased risk of serious birth defects. The warning was directed at health care professionals, as well as users of Depakote (dilvalproex sodium) who are or plan to become pregnant while taking Depakote.
This page contains information on the specific birth defect risks of Depakote, history of Depakote injury, and information about what you should do if you or someone you love has been harmed by Depakote.
Babies who were exposed to Depakote in utero face increased risks such as
- Neural tube defects of the brain and spinal cord
- Craniofacial defects (abnormal formation of the face and skull enclosing the brain)
- Cardiovascular malformations (abnormalities in the heart or blood vessels)
The North American Antiepileptic Drug (NAAED) Pregnancy Registry found there to be 4 times the risk of congenital malformations for infants of women taking Depakote and other drugs containing valproic acid compared to women using other epileptic treatments.
According to data from the Center for Disease Control (CDC), 1 to 2% of infants born to women who took Depakote in the first trimester developed spina bifida or another spinal canal defect. This is 10 times the incidence rate of the general population.
Children whose mothers took Depakote during pregnancy may also be at risk for mental deficiencies. According to a report released by doctors in 2007 and featured in the New York Times, these toddlers scored seven to eight points lower on I.Q. tests at age two than those whose mothers were taking alternative epileptic treatments. Young children who were exposed to Depakote in the womb were twice as likely to score in the range associated with mental retardation than those who were not exposed to the drug. Findings may be considered preliminary because I.Q. measures are less reliable in two-year-olds, and studies will continue to track the children through age six.
The FDA recommends that women who take Depakote speak to their healthcare provider immediately if they are planning a pregnancy or have become pregnant. The birth defects that may result from use of Depakote are serious and may be life-threatening. Research indicates that most birth defects result from taking Depakote in the first trimester, sometimes before the woman knows she is pregnant and can take steps to go off of Depakote. Women who are pregnant should not stop taking Depakote without first speaking to their physicians, as untreated seizures can endanger the life of the fetus and the expectant mother.
Depakote is a valproic acid manufactured by Abbott Laboratories that was approved in 1983 to treat certain types of seizures associated with epilepsy. More than 2 million Americans have some form of epilepsy. Over ten years later, Depakote was approved to prevent migraine headaches and to treat the manic phase of bipolar disorders.
In 2000, the FDA required a black box warning, the strongest warning that the FDA issues, to be added to Abbot Laboratories’ Depakote Tablets, Depakote Sprinkle Capsules, Depacon, and Depakene regarding reports of life-threatening pancreatitis.
In January of 2007, over twenty years after it was originally approved, requirements were made by the FDA for Depakote’s labels to advise of the risk of congenital malformations in infants exposed to Depakote during gestation. The drug was placed in Pregnancy Category C, meaning that animal studies have shown adverse effects on offspring but there were no adequate human studies to reflect this. The benefits of drugs in Category C are shown sometimes to outweigh the possible risk but each case must be determined on an individual basis.
The FDA issued a warning in 2009 stating that medications containing valproate, such as Depakote, are associated with higher risk of neural tube defects and other major birth defects when taken during the gestation period.
Six months later, a study from the Netherlands was published in the New England Journal of Medicine regarding the higher instance of birth defects associated with valproic acid. The birth defects are listed below, some with the increased Depakote-related risk indicated:
- Spina bifida – 12 times more likely
- Craniosynostosis – 7 times more likely
- Hypospadias – 5 times more likely
- Polydactyly – 2 times as likely
- Atrial septal defect
- Cleft palate
The findings from the study were observational, so there were no conclusions drawn as to why valproic acid caused the birth defects. However, the study authors stated, “Our findings provide further support for…the American Academy of Neurology to avoid the use of valproic acid, if possible, in pregnant women.”
In late 2010 and early 2011, more than 50 women filed lawsuits against Abbott Laboratories for its drug Depakote, claiming it caused their children to be born with birth defects. The lawsuits blame birth defects such as spina bifida, cleft palate, heart defects and other birth deformations on Depakote being taken by the mother during pregnancy. The parents claim Abbot Laboratories knew or should have known about the risk of birth defects from Depakote and had a responsibility to warn doctors and patients.
Have you or a loved one suffered Depakote side effects?
At Oshman & Mirisola, our experienced Depakote attorneys will provide you with aggressive representation in the handling of your case. If your infant suffered a birth defect that may have been caused by Depakote, call us at 800-400-8182 or contact us via email to represent your interests in a Depakote lawsuit. We offer a free, no-obligation consultation with a Depakote lawyer so you can learn more about your legal rights and options.