Herbal Spotlight
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 divalproex sodium |
| Depakote, Depakote CP, Depakote ER |
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NEW WARNING
The Food and Drug Administration (FDA) provided information to remind health care professionals about the increased risk of neural tube defects and other major birth defects, such as craniofacial defects and cardiovascular malformations, in neonates exposed to valproic acid, valproate sodium, or divalproex sodium during pregnancy. The FDA plans to work with manufacturers of these products to revise labeling for these antiepileptic medications.
Health care professionals should inform women of childbearing age about these risks and consider alternate therapy, especially if using valproate for treatment of migraines or other non–life-threatening conditions. Those who require valproic acid, valproate, or divalproex should use effective contraception because birth defect risks are highest during the first trimester—before many women know they're pregnant. Pregnant women using valproate or other antiepileptic drugs should be enrolled in the North American Antiepileptic Drug Pregnancy Registry at 1-888-233-2334.
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