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Researchers presented their findings on Monday at an American Epilepsy Society meeting in Baltimore. While a number of studies and reports have focused on congenital birth defects and malformations from Depakote, these scientists looked at the number of children born to women who took Depakote during pregnancy that were later diagnosed as having an autism spectrum disorder.
The researchers looked at data on nearly 656,000 children born in Denmark between 1996 and 2006 and found that 508 had been born to mothers who probably took Depakote during pregnancy. Of that group, 14 developed autism, which the researchers say is a rate 2.6 times higher than the number of children born with autism to mothers who did not take the antiseizure drug.
Depakote was approved in the United States in 1978 for treatment of certain forms of epilepsy. However, Depakote pregnancy use has been linked to an increased risk of a number of severe birth defects, especially when the drug is taken during the first 28 days, when neural tube closure and other critical formations are taking place.
In 2006, the FDA added a “black box” warning about the potential risk of Depakote birth defects after a study found that 20% of pregnant mothers who gave birth while on Depakote had a child with malformations or a birth defect.
One of the more commonly reported problems involves children diagnosed with spina bifidia after Depakote use during pregnancy. However, other birth defects associated with Depakote include, cleft palate, abnormal skull development, malformed limbs, holes in the heart and urinary tract problems.
In May 2010, researchers found that Depakote problems for infants could occur after using the drug as early as the first trimester, which means that by the time many women discover they are pregnant, it could be too late to get off the drug and avoid birth defects for their unborn child.
The FDA also recently issued warnings that Depakote and similar drugs may be linked to cognitive impairments in newborns as well.
Over the past year, a growing number of Depakote lawsuits have been filed by parents of children born with spina bifida and other birth defects after the mother was given the epilepsy drug during pregnancy. The complaints allege that Abbott failed to adequately research the medication or warn consumers about the risks associated with becoming pregnant, placing their desire for profits before patients safety.