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Depakote, Taken While Pregnant, Increases the Risk of Severe Birth Defects

According to class action lawsuits filed against Abbott Laboratories, the makers of Depakote, risks of having a baby born with birth defects are increased for mothers who took the drug while pregnant.

If you or a family member has taken Depakote prior to 2010 while pregnant and have a baby born with birth defects, you may be entitled to compensation.

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About Depakote

Depakote is a popular anticonvulsant drug used to treat epilepsy, migraine headaches and bipolar mania. The drug was approved by the FDA in 1983 to treat certain seizure conditions in adults and children 10 years and older. The drug was later approved to prevent migraine headaches as well as a long-term treatment for severe manic episodes of bipolar disorder. Depakote is the brand name for the generic drugs divalproex sodium, valproate and valproic acid.

Birth defects allegedly caused by Depakote include heart defects, brain defects, spina bifida and other spinal defects and face or skull defects. There have been a number of studies showing mothers are at an increased risk of giving birth to babies born with birth defects than those mothers who did not Depakote while pregnant.

In 2006, the FDA added a black-box warning regarding potential birth defects. The warning came as the result of a study reporting incidents of birth defects in 20% of women who gave birth while taking Depakote. In 2009, the FDA specifically warned about potential neural tube defects, heart defects and craniofacial birth defects.

In a 2010 study published in the New England Journal of Medicine, European researchers reported an increased risk of six different birth defects when Depakote is taken during the first trimester. The risk for spina bifida, in particular, increased 12 times for mothers who were prescribed the drug. In 2011, the FDA warned about a potential link between Depakote and decreased cognitive functioning. Studies have shown that, compared with children of women who did not take the drug, children born to mothers who took Depakote during pregnancy tended to score lower on IQ and other cognitive tests.

Plaintiffs in class action lawsuits claim Abbott Laboratories failed to adequately warn the public about the increased risks of birth defects in pregnant women taking Depakote prior to 2010.