The Cochran Firm Legal Blog

Depakote, a valproate product, is an epilepsy drug that was approved by the FDA in 1983 and is manufactured by AbbVie Inc, formerly Abbott Laboratories. Valproate medications are used to treat seizures, manic or mixed episodes associated with bipolar disorder, and to prevent migraine headaches. Valproate medications include: valproate sodium (Depacon), divalproex sodium (Depakote ER and CP), valproic acid (Depakene and Stavzor) and their generics.

According to the FDA, valproate is known to cause malformation of an embryo. In recent years, women’s use of Depakote and other valproate medications during pregnancy has been linked to an increased risk of severe birth defects and malformations, including spina bifida, cleft palate, abnormal skull formations and other health problems.

In 2011, the FDA released the results from the Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) study that showed children exposed to valproate medications while their mothers were pregnant had decreased IQ scores by age 3 when compared to children whose mothers took other antiepileptic drugs.

Since then, the FDA has worked with valproate manufactures to revise the drug warning labels to include the results of the NEAD study and advises health care professionals that valproate medications, such as Depakote, should not be taken by pregnant women for the prevention of migraine headaches.

The FDA assures that stronger warnings about the use during pregnancy to treat migraines will be added to the drug label and will be changed from a category D, where the potential benefit of the drug during pregnancy may be acceptable despite potential risks, to a category X, where the risk of use in pregnant women clearly outweighs any possible benefit of the drug. Additionally, the FDA recommends that pregnant women with epilepsy or bipolar disorder should only use valproate products if other medications are not effective in treating the condition.

Last year, the Journal of the American Medical Association (JAMA) published results from a Danish study directly linking autism to children whose mothers use valproate medications during pregnancy. The study examined data on every child born in Denmark from 1996 to 2006. The study found that 4.24% of the children exposed to valproate had an absolute risk of developing autism spectrum disorders in life, as compared to the 1.2% of children not exposed to the medication who were likely to develop autism.

JAMA concluded that, “Maternal use of valproate during pregnancy was associated with a significantly increased risk of autism in the offspring, even after adjusting for parental psychiatric disease and epilepsy. For women of childbearing potential who use antiepileptic medications, these findings must be balanced against the treatment benefits for women who require valproate for epilepsy control.”

More recently, in August of 2014, AbbVie Inc. added autism as a potential risk and to the warning label of all valproate products. This change came in response to a recent observational study suggesting that children exposed valproate products during pregnancy had a greater risk of developing autism. While the FDA did approve the change to the warning label, it did not issue a Drug Safety Communication confirming the drugs link to autism.

In the study, children born to mothers who had used valproate medications during pregnancy had 2.9 times the risk of developing autism spectrum disorders compared to children not exposed to the medication. The absolute risk for autism spectrum disorders was 4.4% in children exposed to valproate and 1.5% in children not exposed to the drug. According to the FDA, “Because the study was observational in nature, conclusions regarding a causal association between in utero valproate exposure and an increased risk of autism spectrum disorder cannot be considered definitive.”

Despite the surmounting evidence that Depakote and other valproate related medications may be linked to autism, the FDA is yet to state whether or not there is a definitive link present. For now, warning labels on valproate medications seem to be the only existing safeguard in protecting expecting mothers and their children from the risks associated with the use of valproate and the development of autism.