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.”
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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