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
Depakote and Depakene are prescription medicines from AbbVie Inc. (formerly Abbott) used:
• to treat manic episodes associated with bipolar disorder
• alone or with other medicines to treat:
• complex partial seizures in adults and children 10 years of age and older
• simple and complex absence seizures, with or without other seizure types
• to prevent migraine headaches
Valproate can cause major congenital malformations, particularly neural tube defects (e.g., spina bifida). Valproate should not be administered to a woman of childbearing potential unless the drug is essential to the management of her medical condition. This is especially important when valproate use is considered for a condition not usually associated with permanent injury or death (e.g., migraine)....
More information about the February 2013 warnings about fetal risks associated with Depakote and Depakene, particularly neural tube defects and other major malformations, can be found at these sections of the Depakote / Depakene Prescribing Information, or label, which were added to the label in May 2013:
In addition, at the Patient Counseling Information part of the Depakote / Depakene Package Insert (also called Prescribing Information) at Section 17.3, Birth Defects and Neurobehavioral Development Adverse Effects, there is this statement:
Prescribers should inform pregnant women and women of childbearing potential that use of Depakote during pregnancy increases the risk of birth defects and adverse effects on neurobehavioral development.
Strictly Confidential, No Obligation.
More recently, in May 2013 the FDA issued this Safety Announcement, "FDA Drug Safety Communication: Valproate Anti-seizure Products Contraindicated for Migraine Prevention in Pregnant Women due to Decreased IQ Scores in Exposed Children", which included the following important and updated warning information about Depakote and Depakene:
The U.S. Food and Drug Administration (FDA) is advising health care professionals and women that the anti-seizure medication [Depacon (valproate sodium)] and related products, [Depakene and Stavzor (valproic acid)] and [Depakote, Depakote CP, and Depakote ER (divalproex sodium)], are contraindicated and should not be taken by pregnant women for the prevention of migraine headaches. Based on information from a recent study, there is evidence that these medications can cause decreased IQ scores in children whose mothers took them while pregnant.1 Stronger warnings about use during pregnancy will be added to the drug labels, and valproate’s pregnancy category for migraine use will be changed from "D" (the potential benefit of the drug in pregnant women may be acceptable despite its potential risks) to "X" (the risk of use in pregnant women clearly outweighs any possible benefit of the drug)....
FDA previously communicated initial findings about this risk in a June 2011 Drug Safety Communication ["Children born to mothers who took Valproate products while pregnant may have impaired cognitive development"]. At that time, FDA also worked with valproate manufacturers to revise the drug labels after interim results from the NEAD study showed lower cognitive test scores at age 3 in children exposed to valproate compared to children exposed to other antiepileptic drugs.
According to a May 6, 2013 News Release, "FDA warns pregnant women to not use certain migraine prevention medicines -- Valproate products can lower IQ scores in children of mothers who used them during pregnancy":
The FDA is working with the manufacturers to make changes to the drug labels to reflect this new information and to change the pregnancy category for prevention of migraine headaches to category X (the drug's risks outweigh the drug's benefits for this use) from category D (the drug's benefits outweigh the drug's risks for this use). Valproate products will remain category D for the other two approved indications, epilepsy and manic episodes associated with bipolar disorder.
We will watch for the FDA-mandated drug label revision for Depakote, Depakene, and related products by the drug company AbbVie regarding the lower IQ risk for children whose mother used these medications during pregnancy.
P.S. "Fetal antiepileptic drug exposure and cognitive outcomes at age 6 years (NEAD study): a prospective observational study" (Lancet Neurology, March 2013)