Depakote Pregnancy Side Effects Not Adequately Disclosed by Drug Maker

Austin Kirk

By Austin Kirk
Posted May 13, 2011


According to allegations raised in a number of recent Depakote lawsuits being pursued for children born with spina bifida and other congential malformations, Abbott Laboratories has known or should have known about the risks associated with their anti-epileptic medication for years, yet failed to warn women or the medical community about the potential Depakote pregnancy risks.

>>MORE INFORMATION: Depakote Spina Bifida Side Effects

Abbott Laboratories began marketing Depakote in the United States in 1978. Although it appears that the drug maker should have discovered the risk of birth defects from Depakote before or shortly after the drug was introduced, they sold the drug for years without adequate warnings about the risks associated with use during pregnancy. In addition, even after medical studies began to come out in the 1990s, the warnings provided for women and the medical community continued to be vague and confusing.

Side effects of Depakote use while pregnant have been linked to an increased risk of major congenital malformations or birth defects, especially when the anti-epileptic medication is used during the first few weeks of pregnancy, a time when many women do not even know they are pregnant. Depakote has been linked to a number of problems for unborn children, including:

  • Spina Bifida
  • Cleft Palate and Cleft Lip
  • Cranial defects
  • Limb Malformations
  • Heart Defects
  • Urinary Problems
  • Developmental Delays

A study released in 1995 suggested that the risk of Depakote neural tube defects, such as spina bifida, were ten time higher than with other antiepileptic medications available to prevent seizures. Another study determined that 11% of all infants whose mothers took Depakote early in pregnancy were born with birth defects.

Although safer alternatives were available for pregnant women or women who could become pregnant, Abbott has failed to adequately warn about the risk of birth defects and has attempted to downplay the side effects for unborn children. Even after warnings were added to the medication’s label, Abbott used confusing and understated language to suggest that women should weigh the potential risk, rather than adequately warning about the severity of the problems so that women could understand the true nature and extent of the risk.


The Depakote birth defect lawyers at Saiontz & Kirk, P.A. are reviewing potential lawsuits for children born with health problems that may have been caused by the mother’s use of the medication during pregnancy. If adequate warnings and information about the risk of Depakote pregnancy side effects for babies had been provided, many women would have avoided use of the medication or taken steps to ensure that they did not become pregnant on Depakote.

To review whether your child or family member may be entitled to compensation through a Depakote lawsuit, request a free consultation and claim evaluation.

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