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.
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 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.
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