December 03, 2009
FDA Issues Major Birth Defects Warning For Depakote

Depakote, Abbott's widely-used anti-convulsant for epilepsy and bipolar
disorder, today was the object of a major FDA warning.

"The FDA notified health care professionals and patients about the
increased risk of neural tube defects and other major birth defects, such as
craniofacial defects and cardiovascular malformations, in babies exposed to
valproate sodium and related products (valproic acid and divalproex sodium)
during pregnancy. Healthcare practitioners should inform women of
childbearing potential about these risks, and consider alternative
therapies, especially if using valproate to treat migraines or other
conditions not usually considered life-threatening.

"Women of childbearing potential should only use valproate if it is
essential to manage their medical condition. Those who are not actively
planning a pregnancy should use effective contraception, as birth defect
risks are particularly high during the first trimester, before many women
know they are pregnant."

See:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMed
icalProducts/ucm192788.htm

Philip Dawdy (FuriousSeasons) writes:
Wow is about all I can say. In branded or generic form, Depakote is a drug
taken by millions of American women and yet I have not seen a single press
mention yet of the FDA's new warning. Abbott is under investigation by the
feds for its marketing of Depakote. The FDA earlier this year urged a review
of the drug's possible connection to developmental delay and autism. It has
an FDA mandated warning for suicidality. A New England Journal of Medicine
study linked the drug to lower IQs in the offspring of women taking the
drug. And the drug is linked to an increased risk of ovarian cysts.

What a lovely drug.

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