August 2014 Label Change By AbbVie Inc. (formerly Abbott) For These Valproate Migraine, Epilepsy / Seizure, And Bipolar Medications Was Done Rather Quietly
SUMMARY: In August 2014 the Prescribing Information, or drug labels, for Depakote, Depakote CP, and Depakote ER (divalproex sodium), Depacon (valproate sodium), and Depakene (valproic acid) were updated by the drug company AbbVie Inc. (formerly Abbott) to add a warning about the potential risk for autism spectrum disorders (ASD).
In the label approved by the FDA on August 20, 2014 for Depakote, this new warning about autism spectrum disorders can be found at Section 8.1 Pregnancy.
The medical study referenced in this new “valproate drugs used during pregnancy – risk of autism spectrum disorders” warning seems to be the subject of this article, “Prenatal Valproate Exposure and Risk of Autism Spectrum Disorders and Childhood Autism”, which was published by the Journal of the American Medical Association (JAMA) in April 2013.[Read this article in full at original source]
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