Depakote Birth Defects

Depakote Birth Defects Include Risk of Spina Bifida

For those plagued by seizures, the anticonvulsant drug Depakote (valproate) can be extremely helpful in providing a better quality of life. Also used to treat bipolar disorder, migraine headaches and schizophrenia, Depakote has been on the market since 1983, but over time has gradually been associated with serious side effects.

Early reports involved cases of life-threatening pancreatitis, with later incidences of liver failure and an increased risk of suicidal thoughts and behavior, but perhaps most concerning are Depakote birth defects. Unfortunately, some women were not adequately informed of the risk, and have since turned to a Depakote lawyer for advice.

Studies Show Increased Risk of Depakote Birth Defects

In 2001, the New England Journal of Medicine published a study showing that infants exposed to anticonvulsant drugs like Depakote had a significantly higher frequency of congenital abnormalities than those who weren’t, including hypoplasia of the midface and fingers and growth retardation.

In 2004, a study presented at the annual meeting of the American Academy of Neurology showed that women taking Depakote early in pregnancy were more likely to give birth to babies with birth defects and developmental delays. In fact, such abnormalities occurred in 28 percent of children whose mothers took the drug, compared with only 2 percent of those who took Lamictal, an alternative anticonvulsant drug. Researchers expressed concern because Depakote was being prescribed for other conditions in addition to epilepsy, exposing more women of childbearing age to the increased risk.

Depakote Birth Defects Dose-Dependent

Again in 2005, researchers found that valproate created a greater risk of birth defects—including spina bifida, a wide variety of malformations, and developmental delays—than other antiseizure medications. The risk for women taking the drug was nearly 11 percent. In 2006, Neurology (August 8, 2006) reported that congenital malformations, including heart defects, and fetal deaths were more common in women who took Depakote than other antiepileptic drugs, and that the risk was higher (nearly 25 percent) for higher doses (900 mg/day).

The FDA Warns Physicians of Depakote Birth Defects

In December 2009, the FDA released an official reminder to healthcare professionals concerning the increased risk of neural tube birth defects and other major birth defects in babies exposed to valproate during pregnancy. They added that data from the NAAED Pregnancy Registry showed the rate of major malformations in babies born to women taking valproate was almost 4 times higher than for those born to women taking an alternative epileptic medication.

Two years later, in June 2011, the FDA warned the public that children born to mothers taking Depakote had a higher risk of lower cognitive test scores than children exposed to other antiseizure medications. They urged healthcare professionals to weigh carefully the benefits and risks of valproate when prescribing them to women of childbearing age, and to use alternative medications whenever possible. The agency has classified Depakote as a pregnancy category D medication, which means that evidence in human studies show the drug’s potential to cause real harm to an unborn baby.

Parents May Benefit from a Depakote Lawsuit

Many parents who have children affected by Depakote birth defects believe that the manufacturer, Abbott Laboratories, should be held responsible for failing to adequately warn the public about the serious risks. With solid scientific data showing the link between Depakote and Depakote birth defects, a Depakote lawyer is likely to stand a good chance at winning compensation for plaintiffs. Contact Chaffin Luhana LLP today for a confidential case evaluation at 1-888-480-1123