August 2014 Label Change By AbbVie Inc. (formerly Abbott) For These Valproate Migraine, Epilepsy/Seizure, And Bipolar Medications Was Done Rather Quietly
(Posted by Tom Lamb at DrugInjuryWatch.com)
Without much notice, e.g., no FDA Drug Safety Communication was issued, 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 (accessed 9/25/14), this new warning about autism spectrum disorders can be found at Section 8.1 Pregnancy:
An observational study has suggested that exposure to valproate products during pregnancy may increase the risk of autism spectrum disorders. In this study, children born to mothers who had used valproate products during pregnancy had 2.9 times the risk (95% confidence interval [CI]: 1.7-4.9) of developing autism spectrum disorders compared to children born to mothers not exposed to valproate products during pregnancy. The absolute risks for autism spectrum disorders were 4.4% (95% CI: 2.6%-7.5%) in valproate-exposed children and 1.5% (95% CI: 1.5%-1.6%) in children not exposed to valproate products. 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.
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. From the Conclusions section of this JAMA medical journal article:
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.
Strictly Confidential, No Obligation.
And for a better understanding of this still relatively "new" Depacon / Depakene / Depakote - autism side effect issue, we refer you to the very informative National Institute of Mental Health (NIMH) web page "What Is Autism Spectrum Disorder?":
Autism spectrum disorder (ASD) is characterized by:
• Persistent deficits in social communication and social interaction across multiple contexts;
• Restricted, repetitive patterns of behavior, interests, or activities;
• Symptoms must be present in the early developmental period (typically recognized in the first two years of life); and,
• Symptoms cause clinically significant impairment in social, occupational, or other important areas of current functioning.
The term “spectrum” refers to the wide range of symptoms, skills, and levels of impairment or disability that children with ASD can have. Some children are mildly impaired by their symptoms, while others are severely disabled....
Previously, in a May 2013 post, we reported that children born to mothers who took any of the valproate medications -- valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, and Depakote ER), valproic acid (Depakene and Stavzor), and their generics -- may have other serious side effects:
Depakote Or Depakene Taken During Pregnancy May Cause Congenital Malformations Or Birth Defects Such As Neural Tube Defects Like Spina Bifida
In Addition, There Are FDA Warnings That Using Depakote Or Depakene While Pregnant May Put Child At Risk For Having A Lower IQ Score Later In Life
As regards lawsuits and legal claims, we expect that the Depacon / Depakene / Depakote drug injury litigation which previously was focused on certain types of birth defects or congenital malformations will expand to include cases of autism spectrum disorder (ASD) and autism.