What Parents Should Know About Possible Birth Defects From Anticonvulsants

The FDA released a MedWatch Safety Alert in December 2009 which notified health care professionals and patients about the increased risk of major birth defects in babies exposed to valproate sodium (a sodium salt of valproic acid) during pregnancy, which included the following recommendation: "women who are planning a pregnancy or who become pregnant while taking valproate should contact their health care professionals immediately." Drugs containing valproic acid compounds include brand names such as Depakote, Depakote ER, Depakene, Depacon, divalproex sodium, Depakote CP and Stavzor

Valproic acid is a chemical compound found in various anticonvulsant medications. Physicians prescribe these drugs for people with seizure disorders, epilepsy, the manic phase of bipolar disorders and migraine headaches. Since its approval by the U.S. Food & Drug Administration (FDA) in 1967, valproic acid and the brand name drug Depakote have proven to be effective in these patients.

However, once a prescription drug is approved, the FDA, independent laboratories and others continue to study its use and any side effects that patients may experience. Over time, additional studies have revealed a potential connection between anticonvulsant drugs taken by pregnant women and a number of serious birth injuries including spina bifida, cleft palate, craniofacial defects, cardiovascular malformations and neural tube birth defects.

The American College of Obstetricians and Gynecologists (ACOG) states that three of every 100 babies in the United States are born with a major birth defect. Many of these birth defects can be treated and even cured, but collectively they are the leading cause of death during the first year of a baby's life.

In some cases, pregnant women must take drugs such as Depakote to treat their epilepsy. The FDA recommends that these women should consider enrolling in the North American Antiepileptic Drug Pregnancy Registry by calling 1-888-233-2334 or visiting AEDPregnancyRegistry.org. According to the Registry, there are 16 reported cases of birth defects in newborns of 149 women with epilepsy. They were taking approximately 1,000 mg of valproic acid-based medication per day during the first trimester of their pregnancies. Three of those 16 cases were neural tube defects.

The March of Dimes calculates that caring for a child with a birth defect will cost $140,000 to $170,000 during his or her lifetime. Spina bifida's lifetime treatment is even more expensive, costing almost $300,000. It is this financial and emotional burden of caring for a child with a major birth injury that may have severe impact on the quality of life for these families for years to come.