Safety Alerts & Recalls

What does this mean?

Using valproate sodium, valproic acid, or divalproex sodium during pregnancy increases the chance of having a baby with a birth defect. Women of childbearing potential who take valproate sodium, valproic acid, or divalproex sodium should use effective birth control (contraception) while taking these medicines.

In general, valproate sodium, valproic acid, or divalproex sodium should be avoided during pregnancy unless it is the only therapy that works to control your condition. If you are of child bearding age and are planning to become pregnant or if you become pregnant while taking valproate sodium, valproic acid, or divalproex sodium, please talk to your doctors (including your neurologist and obstetrician) as soon as possible about the best way to treat your health condition. These medicines should not be stopped without talking to a healthcare professional, even in pregnant women. Stopping these medicines suddenly can cause serious problems. Not treating epilepsy or bipolar disorder can also be harmful to women and their developing babies.

Women who become pregnant while taking valproate sodium, valproic acid, or divalproex sodium 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.

Risk of Neural Tube Birth Defects Following Prenatal Exposure to Valproate Sodium, Valproic Acid, or Divalproex Sodium

The FDA has issued an alert to all healthcare professionals to remind them 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. The FDA is working with the manufacturers to highlight this information in the prescribing information and the new Medication Guides to be provided to patients with each prescription fill. Valproate sodium is marketed in the as Depacon. Divalproex sodium is marketed as Depakote, Depakote CP, Depakote ER. Valproic acid is marketed as Depakene and as Stavzor. These medicines are commonly used to treat epilepsy, migraines, and mania associated with bipolar disorder. For more information, please visit: more information here

Source: FDA
Publication Date: 2009-12-08
Last Updated: 2009-12-08

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