The FDA is reminding health care professionals of the risk of major birth defects (MBDs) in babies exposed to one of the few medications to be FDA approved for Migraine prevention during the mother's pregnancy.
Valproate sodium and related medications subject to this warning include:
- divalproex sodium: Depakote, Depakote CP, Depakote ER
- valproate sodium: Depacon
- valproic acid: Depakene and Stavzor
Women who take these medications during pregnancy have an increased risk of giving birth to children with neural tube defects and other major birth defects, such as craniofacial defects and cardiovascular malformations. In the United States, about 1 in 1,500 babies is born with a neural tube defect. The risk of neural tube defects is much higher in babies born to mothers treated with valproate during the first 12 weeks of pregnancy, with the risk increasing to 1 in 20 babies.
Studies in the general population show that folic acid supplementation prior to conception and during early pregnancy reduces the risk of neural tube defects. To ensure adequate folic acid intake, women of childbearing potential should use FDA approved folic acid prescription drugs and not rely on dietary intake or supplements alone.
The FDA has published this information for patients:
- Using valproate during pregnancy increases the chance of having a baby with a birth defect. Neural tube defects, such as spina bifida, are the birth defects most often seen with valproate use in early pregnancy. These defects of the brain and spinal cord occur when the developing spinal canal does not close normally.
- For this reason, a woman of childbearing potential should generally not take valproate unless it is considered essential for her treatment. Women of childbearing potential are women who have passed puberty and have not passed through menopause and have not had their uterus or ovaries removed.
- Women of childbearing potential who do take valproate should use effective birth control (contraception) while taking valproate.
- Women who are planning a pregnancy or who become pregnant while taking valproate should contact their health care professionals immediately. They should talk to their health care professionals about the best way to treat their health conditions before and during pregnancy. Health care professionals may discuss other treatment options.
- Valproate should not be stopped without talking to a health care professional, even in pregnant women. Stopping valproate suddenly can cause serious problems. Not treating epilepsy or bipolar disorder can be harmful to women and their developing babies.
- Women who become pregnant while taking valproate or other antiepileptic drugs (AEDs) should consider enrolling in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. Women can do this by calling the toll-free number 1-888-233-2334. This pregnancy registry gathers information about the safety of antiepileptic drugs during pregnancy.
- It is important to know that birth defects also occur in babies born to women who are not taking any medicines and who do not have other risk factors, but they occur less often (in about 3 out of every 100 babies).
- Taking folic acid supplements before getting pregnant and during early pregnancy has been shown to lower the chance of having a baby with a neural tube defect.
- Women should tell their health care professionals about all the medicines they take, including prescription and non-prescription medicines, vitamins, and herbal supplements, and should not start a new medicine without first talking with a health care professional.