Study Links Risk of Autism and Depakote Use During Pregnancy

Danish researchers have released a new study that adds to the mounting evidence linking the use of Depakote and autism among children exposed to the medication during pregnancy.  

According to a report published in the Journal of the American Medical Association (JAMA) on April 24, pregnant women taking the epilepsy drug valproate, which is contained in the brand name medications Depakote, Depacon and others, may be three times as likely to give birth to a child who has an autism spectrum disorder than a woman who does not take the drug.

Researchers looked at data on all children born in Denmark between 1996 and 2006. Out of the nearly 656,000 children born during that time period, 5,437 were diagnosed as having an autism spectrum disorder, including 2,067 with childhood autism.

The study found that 508 of the mothers had taken Depakote or another valproate drug during pregnancy, and 4.4% of them had a child that was eventually diagnosed with an autism spectrum disorder by 2010. That compares to only 1.5% of children born to women who did not take the drug.

The study echoes findings by British researchers released earlier this year, who found that women who took Depakote during pregnancy were six times more likely to have a child with developmental disorders. The most common disorder was autism.

The preliminary findings of this most recent study were unveiled at an American Epilepsy Society meeting in Baltimore in 2012. This is the first time the study has been peer-reviewed and published.

Depakote was approved in the United States in 1978 for treatment of certain forms of epilepsy. However, side effects of 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.

An increasing number of parents are now pursuing a Depakote lawsuit after the mother took the epilepsy drug and gave birth to children with spina bifida and other birth defects. 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.

Giving the emerging evidence supporting a link to cognitive delays and lower I.Q., a number of families are now considering potential Depakote autism or developmental delay lawsuits as well.