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Pregnant women with epilepsy who took the seizure drug topiramate, which is sold by Johnson and Johnson under the brand name Topamax, increased their risk of having an infant with birth defects, especially when taken in combination with another drug called valproate, according to astudy published in the July 22 issue of journal Neurology, theLos Angeles Times reports. According to the Times, some experts were "quick to caution" that the study involved only 203 women and that "significant statistical uncertainty remained" concerning the research.

For the study, John Craig of the Royal Group of Hospitals in Belfast, Northern Ireland, and colleagues examined women who took part in theU.K. Epilepsy and Pregnancy Register and who became pregnant while taking Topamax on its own or in combination with other epilepsy drugs. The study found that of the 203 pregnancies, 18 ended in spontaneous abortions, five ended in induced abortions and two ended in stillbirths. Of the 178 infants born, 16 had major birth defects, including four infants with cleft palates or lips, and four male infants with genital birth defects. According to the study, in three of the 16 cases, the women had taken only Topamax, and in the other 13, the women had taken Topamax in combination with other drugs.

Despite the risk, some physicians said that epileptic women cannot stop taking the drugs during pregnancy because seizures also can damage the fetus. Craig said that women who are taking Topamax to prevent migraines should stop using it if they become pregnant or are planning to become pregnant (Maugh, Los Angeles Times, 7/22).

Andre Kanner -- associate director of theRush University Medical Center'sEpilepsy Center, who was not a part of the study -- said the risk of having an infant with birth defects depends on a combination of factors, not all of which were evaluated in the study, such as the age and family history of the women. "This study should raise a red flag, but we don't want to start jumping to conclusions because there are other variables to consider," Kanner said. He added, "That said, I would keep an eye open and use topiramate carefully in epileptic women, especially in those on combination therapy" (Marcus,USA Today, 7/22).

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