The FDA has notified health care professionals and patients about the increased risk of neural tube defects and other major birth defects (e.g. craniofacial defects and cardiovascular malformations) in babies exposed to valproate sodium and related products (valproic acid and divalproex sodium) during pregnancy. The Agency has made the following recommendations:

• Women of childbearing potential should be informed about these risks.

• Alternative therapies should be considered, 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.

• Women 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.

• Pregnant women using valproate or other anticonvulsants should be encouraged to enrol in the North American Antiepileptic Drug (NAAED) Pregnancy Registry.