The FDA has notified healthcare professionals and patients about the increased risk of neural tube defects and other major birth defects (eg, craniofacial defects and cardiovascular malformations) in babies exposed to valproate sodium and related products (valproic acid and divalproex sodium) during pregnancy. Healthcare providers 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. Pregnant women using valproate should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry.

For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192788.htm.