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Birth Defect Study Inconclusive on Topamax

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A recent study was unable to determine if pregnant women who take the antiepileptic drug Topamax are at risk for having children with major birth defects. The Danish study appeared today in the Journal of the American Medical Association and tested the association between fetal exposure to antiepileptic drugs during the first trimester of pregnancy and the risk of birth defects.

The study included data on 837,795 live births occurring in Denmark between January 1996 and September 2008, including 1,532 women taking a second-generation antiepileptic drug during their first trimester.

According to WebMD, just over 100 of the 800,000 women in the Danish registry took Topamax, said researcher Anders Hviid, MSc, of Copenhagen’s Statens Serum Institute. Other antiepileptic drugs studied included Lamictal, Trileptal, Neurotonin, and Keppra.

Of the women who took Topamax, 4.6 percent delivered babies with major birth defects, while 3 to 4 percent taking Lamictal experienced birth defects.

Overall, major birth defects occurred in 3.2 percent of infants exposed to new-generation antiepileptic drugs early in development, compared to 2.4 percent of babies not exposed to any drugs.

Although the Danish study could not conclude or make recommendations on the use Topamax because few of the women included were taking the medication, in March, the Food and Drug Administration (FDA) issued a warning that Topamax used during the early months of pregnancy could cause cleft lip and palate in newborns. The Medication Guide states that women taking Topamax during pregnancy have, “a higher risk for birth defects” and that “these defects can begin in early pregnancy, even before you know you are pregnant.”

The FDA also advises women taking Topamax during pregnancy to register with the North American (AED) Antiepileptic Drug Pregnancy Registry. The AED Pregnancy Registry was “established in 1997 with the objective to obtain information on the frequency of major malformations among infants whose mothers had taken one or more antiepileptic drug.” Several clinical studies, including the recent Danish study, obtain information from nationwide registries to compile data. According to WedMD, a study using registry data assisted FDA officials in their warning about Topamax.

Jacqueline A. French, MD, told WebMD that, “The findings are reassuring because if the rates of fetal malformation were as high as with Depakote, even with the small sample sizes in this study we would see it, but the findings are not reassuring enough to say that we are out of the woods with all of these drugs.”

Depakote is an older-generation epileptic medication.

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