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New research appears to provide additional evidence that use of the epilepsy drug Depakote while pregnant may increase the risk of giving birth to a child with autism or other developmental delays.
In a study published online by the Journal of Neurology, Neurosurgery &; Psychiatry on January 31, British researchers found that children born to women who used Depakote during pregnancy had a greater risk of experiencing potentially severe developmental delays, and similar associations were not seen among children exposed to Tegretol or Lamictal before birth.
Researchers looked at data on more than 500 pregnant women between 2000 and 2004, and found that children exposed to Depakote during pregnancy were six times more likely to have a developmental disorder than children of mothers who did not have epilepsy. When Depakote was used in combination with other drugs, the rate jumped to 10 times. The most common disorder was autism.
The findings come just more than a year after Danish researchers unveiled similar results at an American Epilepsy Society meeting in Baltimore. That much larger study found that mothers who took Depakote during pregnancy were 2.6 times more likely to have a child with autism than those 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, including spina bifida, cleft palate, abnormal skull development, malformed limbs, holes in the heart and urinary tract problems; 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.
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.