Taking anti-epileptic drug in early pregnancy may increase the risk of oral clefts in babies, a US study warns.
The research, published in the journal Neurology, leverages nationwide Medicaid data in the US on more than one million live births between 2000 and 2010.
The team from Brigham and Women's Hospital and the Harvard T H Chan School of Public Health in the US examined the risk of oral clefts - including cleft palate or cleft lip - among three groups.
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The first group included infants born to women who had taken topiramate in their first trimester and the second group included infants born to women who had taken the drug lamotrigine (an unrelated drug used to treat bipolar disorder and epilepsy).
The third group included infants who had not been exposed to anti-epileptic medications in utero.
The researchers found that the risk of oral clefts was approximately three times higher for the topiramate group than for either the lamotrigine or the unexposed group.
About one out of every 1,000 infants are born with an oral cleft, but among infants exposed to low doses of topiramate (median 100-milligrammes daily dose) in the first trimester, that risk was 2.1 out of every 1,000 live births.
Among women taking higher dose topiramate (median 200- milligrammes daily dose), the risk was much higher - 12.3 for every 1,000 live births.
"Our results suggest that women with epilepsy on topiramate have the highest relative risk of giving birth to a baby with cleft lip or cleft palate, likely due to the higher doses of topiramate when used for controlling seizures," said Sonia Hernandez-Diaz, from the Harvard T H Chan School of Public Health.
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