Valproate (Depakote) Birth Defect Risk 30 to 80 Times Higher

Washington, DCIt has long been known that Depakote, which is used to treat and manage epilepsy, carries a high risk for birth defects when prescribed to pregnant women. The US Food and Drug Administration (FDA) quietly issue a "reminder" to women and their doctors in December of last year with regard to the risks associated with valproate sodium and related products (valproic acid and divalproex sodium) during pregnancy.

The FDA notes that it first approved valproic acid in 1978 for the treatment of epilepsy. Valproate, used for the treatment of bipolar disorder and migraine headaches, came some time later. Given the expanded uses and indications for valproate, the FDA issued a communiqué on December 9, 2010, alerting health care professionals to the dangers and risks associated with the class of drugs.

"It is critical that all health care professionals caring for women of childbearing potential and taking valproate for any indication be informed that valproate causes an increased risk of major birth defects," the FDA wrote. "Awareness of the therapeutic benefits and risks of valproate and alternative therapies, as well as the risks of untreated disease, is critical for informed prescribing and counseling of all women taking valproate."

The FDA notes the increased risk for spinal bifida and cleft palate, including craniofacial deformities and cardiovascular malformations. What's more, about one out of every 1500 babies are born in the US with a neural tube defect. Among babies whose mother use valproate during the first 12 weeks of pregnancy, the risk increases remarkably: one out of 20 are born with a neural tube defect.

"Valproate use during early pregnancy increases the risk of major malformations in the baby," notes the FDA. "The rates for neural tube defects in babies exposed to valproate during the first trimester are 30 to 80 times higher than the rate for neural tube defects in the general US population. In pregnant women with epilepsy, valproate monotherapy is associated with a four-fold higher rate of major malformations than other antiepileptic drug monotherapies.

"Healthcare professionals should counsel women of childbearing potential taking valproate about the increased risk of major malformations, including neural tube defects, when valproate is used during pregnancy. Healthcare practitioners should recommend use of effective contraception for women who are not planning a pregnancy and discuss the relative risk and benefits of appropriate alternative therapies."

The FDA noted that the use of folic acid prior to pregnancy and during the first trimester could decrease the risk for congenital tube defects.

The FDA instructs the health care provider to properly inform patients about the risks associated with Depakote in association with pregnancy, in an effort to better manage the potential risks for Depakote birth defects. Failure to communicate these risks could result in a Depakote lawsuit.