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Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

Depacon Linked to Increased Risk for Autism

Posted in Depacon / Depakene / Depakote

In April of this year, Journal of the American Medical Association published a case-controlled study, by Jakob Christensen, PhD et al., showing a clear association between prenatal sodium valproate (Depacon, Depakene, Depakote) exposure and increased risk of autism spectrum disorder and childhood autism.

Sodium valproate (also “valproic acid,” “divalproex sodium”) is the main ingredient in a number of antiepileptic medications on which more than 2 million Americans rely.

The Christensen et al. (2013) study analyzed “all children born alive in Denmark from 1996 to 2006” and “[Used national registers] to  identify children exposed to valproate during pregnancy and diagnosed with autism spectrum disorders (childhood autism [autistic disorder], Asperger syndrome, atypical autism, and other or unspecified pervasive developmental disorders).”

“Of 655 615 children born from 1996 through 2006, 5437 were identified with autism spectrum disorder, including 2067 with childhood autism.”  This places the overall rate of children born with autism (of any kind) at about 1%, a figure consistent with overall global rates.  Further statistical analysis showed that “the estimated absolute risk after 14 years of follow-up was 1.53%”

When Christensen et al. (2013) reviewed only children exposed to valproate during pregnancy, however, the overall rate of autism spectrum disorder was found to be about 4.42%.  This means that children exposed to valproate were 2.9 times as likely to be born with autism spectrum disorder than children not exposed to the drug during pregnancy.  Similar results were found for childhood autism.

This, however does not yet show whether valproate causes autism, for every woman taking valproate during pregnancy had epilepsy, and therefore it may have been simply that maternal epilepsy causes autism, and not sodium valproate.

So, with this in mind, Christensen et al. (2013) determined the rate for autism among women who were epileptic but did not use valproate during pregnancy.  The rate for autism among children born to these women dropped to 2.44%.  This more conclusively shows that sodium valproate is the culprit, and not maternal epilepsy.

The authors of this study conclude as follows: “Maternal use of valproate during pregnancy was associated with a significantly increased risk of autism spectrum disorder and childhood autism in the offspring, even after adjusting for maternal 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.”

Due to the fact that the association between sodium valproate (Depacon) and autism spectrum disorder was not made clear to women who used Depacon during pregnancy, a number of Depacon lawsuits are currently being filed.

If you or a loved one used Depacon during pregnancy and your child was born with autism spectrum disorder or childhood autism, you may be entitled to significant financial compensation for undue suffering to your family.

For a more information, or a free, no-obligation case consultation, contact our team of Depacon lawyers.  At your convenience, you may reach our offices by phone at (855) 452-5529 or by e-mail at justinian@dangerousdrugs.us.

Our Depacon Lawsuit Information page is a great place to start if you have any more questions about Depacon.