FDA Links Depakote to Autism

Seattle, WAOver the past few years, a number of women who took Depakote while pregnant have filed complaints with LawyersandSettlements regarding a possible link to autism. The FDA has finally acknowledged that exposure to Depakote during pregnancy may increase the risk of autism spectrum disorders.

In August 2014, AbbVie Inc. (formerly Abbott), the manufacturer of Depakote, added to its warning label the potential risk for autism. Interestingly, the FDA at that time did not issue a Drug Safety Communication.

Back in September 2011, Depakote attorney Andy Hollis said the jury was still out in regard to autism. While warnings of physiological birth defects were stated in the drug label, cognitive problems, including autism, were not. Even though the esteemed JAMA (Journal of the American Medical Association) in April 2013 published an article titled “Prenatal Valporate [Depakote] Exposure and Risk of Autism Spectrum Disorders and Childhood Autism,” it took the FDA more than a year to suggest any connection.

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.”

And a Depakote lawsuit was filed earlier this year on behalf of a child diagnosed with multiple autism spectrum disorders, whose mother took Depakote during her pregnancy. The lawsuit claims that AbbVie and Abbott Laboratories knew or should have known of Depakote’s dangers and risks to a fetus when taken by pregnant women, including the risk of cognitive problems including autism.

The lawsuit, which was filed by Zoll, Kranz & Borgess (ZKB) in the United States District Court for the Southern District of Illinois on January 10, 2014, claims that the drugmaker failed to adequately warn or instruct women, their physicians or the general public of the nature and extent of the risks to a fetus. Instead, AbbVie and Abbott promoted the drug, including for off-label uses, even though there were other common drugs that were as effective or more effective for treatment of those conditions and that do not involve the severe risks associated with Depakote. The case number is 3:14-cv-00035-JPG-DGW.

For almost a decade, Sharon suspected that Depakote played a role in her son’s autism disorder. “My doctor told me that my chances of getting pregnant were almost nil, so I was both delighted and terrified when I discovered that I was eight weeks pregnant - I was on Depakote,” she says. “Even though I stopped taking it immediately, my 10-year-old son was born with a mild form of cerebral palsy and he was diagnosed with autism a few years ago.”

Now that the FDA has weighed in, Sharon believes she will prevail in a Depakote autism lawsuit. “I am hopeful that we can get some compensation from the drug company, at least enough to pay for special education that I can’t afford now,” Sharon adds.