On December 3, 2009 the U.S. Food & Drug Administration (FDA) issued a warning about the use of Valproate Sodium, Valporate Acid and Divalproex Sodium. These drugs have been linked to the increased risk of serious birth defects in newborns born to mothers that took them while pregnant / during pregnancy.
The FDA has provided the following recommendations to patients taking Valporate Sodium and related products:
- 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 healthcare professionals immediately.They should talk to their healthcare professionals about the best way to treat their health conditions before and during pregnancy. Healthcare professionals may discuss other treatment options.
- Valproate should not be stopped without talking to a healthcare 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 healthcare 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 healthcare professional.