FDA warns against the use of valproate during pregnancy

In a safety communication issued Monday, the FDA said that anti-seizure medications containing valproate and related compounds, including AbbVie's Depakote (divalproex) and Noven Pharmaceuticals' Stavzor (valproic acid), should not be taken by pregnant women for the prevention of migraines. The FDA indicated that it is working with drug manufacturers to help them update their product labels to indicate that the drugs' risks outweigh their benefits concerning migraine prevention.

The US regulator warned that recent study results suggest the drugs, which already carry a boxed warning concerning the risks of birth defects, can lower the IQ scores of children at age 6 by 8 to 11 points if their mothers took valproate products during pregnancy, compared with those exposed to other anti-epileptic drugs during pregnancy. The FDA added that the drugs should only be used by pregnant women to treat epilepsy or bipolar disorder if other drugs are ineffective or contraindicated.

In June 2011, the agency issued a warning concerning the effects of valproate on the cognitive ability of children after a study identified reduced cognitive function in children exposed to Depakote or generic versions of the drug during pregnancy, compared with those born to mothers who took other anti-seizure medications during pregnancy.

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