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FDA Issues Reminder on Valproate Birth Defect Risks

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The Food & Drug Administration (FDA) reminded health care providers today that Valproate has been associated with a higher risk of neural tube defects and other major birth when taken by pregnant women.

Valproate was approved in 1978 for the treatment of epilepsy. More recently, the FDA approved valproate for the treatment of bipolar disorder and migraine headaches.

According to data from the North American Antiepileptic Drug (NAAED)  Pregnancy Registry, the rate of major malformations in babies born to women with epilepsy taking valproate as  monotherapy is almost 4 times higher than the rate of major malformations in babies born to women with epilepsy taking a different antiepileptic drug. The NAAED Registry reported a major malformation rate of 10.7% children born to  women exposed to an average of 1,000 mg/day of valproic acid monotherapy during pregnancy.   Sixteen major malformations occurred in the offspring of 149 women who used valproate during pregnancy, and these malformations included neural tube defects, craniofacial defects, cardiovascular malformations and malformations involving other body systems.

In contrast, the major malformation rate among the internal comparison group of 1,048 women with epilepsy who received any other antiepileptic drug monotherapy during pregnancy was 2.9%, the FDA said.

The agency said women of childbearing potential should only use valproate if it is essential to manage their medical condition. Women not actively planning a pregnancy should use effective contraception if they are taking valproate, as birth defect risks are particularly high during the first trimester, before many women know they are pregnant.

Finally, the FDA is encouraging women who become pregnant while taking valproate or other antiepileptic drug  to enroll in the NAAED Pregnancy Registry by calling the toll-free number 1-888-233-2334. Information on the registry can also be found at the website www.aedpregnancyregistry.org. The NAAED registry gathers information about the effects of antiepileptic drugs during pregnancy.

Valproate sodium is marketed as Depacon.  Dilvalproex sodium is marketed as Depakote, Depakote CP, Depakote ER. Valproic acid is marketed as Depakene and as Stavzor.  The FDA said it  will be working with the manufacturers of valproate products to address labeling changes.

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