FDA Date: 12/2/09
Depakote (divalproex sodium) FDA Drug Safety Communication
Information for Healthcare Professionals: Risk of Neural Tube Birth Defects Following Prenatal Exposure to Valproate
FDA is reminding healthcare professionals 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. FDA has required a Medication Guide to help patients understand the benefits and risks associated with valproate therapy.
This information reflects the current analysis of data available to FDA concerning this drug. FDA intends to update this communication when additional information or analyses become available.