Abbott Laboratories, the manufacturer of the drug Depakote, is facing numerous lawsuits claiming the medication can cause tragic complications to pregnancies, including serious birth defects like spina bifida, a mishaped skull, and congenital heart defects.

Depakote, an anti-seizure medication that is also approved to treat bipolar disorder and headaches, is derived from a compound called valproic acid. Depakote birth defect lawsuits accuse Abbott of marketing the drug to women of childbearing age without including clear warnings about the risks of using valproic acid while pregnant.

Many of these accounts of Depakote birth defects come from women who did not plan to become pregnant while taking the drug, or were not aware they were pregnant until many weeks into their pregnancy. These women are devastated to learn that even though they immediately stopped taking Depakote upon learning they were pregnant, the effects of their Depakote pregnancy use already caused their unborn baby to develop birth defects.

In fact, the first trimester is a critical period as studies have shown that women who take valproic acid during the first three months of pregnancy are more likely to have children with birth defects than women who take other epilepsy drugs or no medicine at all to control their seizures.

One such study, published in the June 2010 issue of the New England Journal of Medicine, found that taking valproic acid during pregnancy increased increased the risk of the following six birth defects:

• Spina bifida (12.7 times more likely) – a birth defect involving incomplete development of the spinal cord or its coverings
• Craniosynostosis (6.8 times more likely) – a birth defect that causes one or more sutures on a baby’s head to close earlier than normal, leading to an abnormally shaped head
• Hypospadias (5.2 times more likely) – a birth defect in which the opening of the urethra is on the underside, rather than at the end, of the penis
• Cleft palate (4.8 times more likely) – a birth defect that affects the upper lip and the roof of the mouth
• Atrial septal defect (2.5 times more likely) – a congenital heart defect in which the wall that separate the upper heart chambers does not close
• Polydactyly (2.2 times more likely) – a condition in which a person has more than five fingers per hand

“In summary, we found that exposure to valproic acid during the first trimester was associated with increased risks of six specific malformations, as compared with no exposure to antiepileptic drugs, and the risks of five of these six malformations remained significantly increased when we compared valproic acid exposure with exposure to other antiepileptic drugs,” researchers said in their report, adding that drugs containing valproic acid should not be prescribed to women of childbearing age.

“Our findings provide further support for the recommendation of the American Academy of Neurology to avoid the use of valproic acid, if possible, in pregnant women. Since switching drugs during or just before pregnancy is difficult, the risks associated with valproic acid use should be routinely considered in choosing therapy for women with childbearing potential.”

It’s findings like these that are used as evidence in Depakote birth defect lawsuits. Plaintiffs allege that drug makers should have known that Depakote pregnancy use was dangerous and more strongly warned women of the risk of birth defects linked to their drug.

Depakote Birth Defect Lawsuits

Depakote lawsuits typically make similar allegations. These lawsuits often cite the fact that research studies dating back to the 1980s have suggested that Depakote and similar drugs are a serious risk factor for congenital defects. In the case of some of these birth defect lawsuits, doctors have come forward and said they would have been more careful in prescribing the drug had they been aware of the pregnancy risks associated with Depakote.

These Depakote lawsuits typically further allege that not only were drug makers aware of the risk of birth defects allegedly associated with valproic acid, but that drug makers have deliberately downplayed these risks and continued to aggressively promote their drug to women of childbearing age.

–Additional reporting by Robert J. Boumis