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DepakoteFDA Advisory

Studies show Depakote has ties to birth defects

The use of Depakote has been linked to a variety of birth defects in the babies of mothers who took the drug while pregnant. Birth defects involving the face, skull, brain, spinal cord, heart, and blood vessels have been linked to Depakote use.

Depakote, an anti-seizure medication, was originally approved by the FDA in 1983. Since then, numerous studies have examined its effects on individuals who take it. Many of these studies have focused on the way the drug affects the babies of women who ingested the drug while pregnant.

In 2001, the New England Journal of Medicine reported that anticonvulsant drugs, such as Depakote, are one of the greatest potential sources of risk for an unborn fetus. That study showed that infants whose mothers took these drugs while pregnant had a much higher risk of developing certain birth defects than babies whose mothers had not taken them.

In that study, babies who were exposed to one anticonvulsant drug in utero suffered from birth defects at a rate of more than 20 percent, while babies who were not exposed to these drugs in utero suffered from defects at a rate of only 8.5 percent.

A 2005 study in the journal Neurology showed that women who took drugs containing valproate had an increased risk of giving birth to babies with birth defects. Valproate is the active ingredient in Depakote.

Based on studies like these, experts believe taking Depakote while pregnant can put unborn babies at risk for future health problems.

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