According to a study published in Neurology, babies born to pregnant women taking lamotrigine may not be at an increased risk of birth defects, such as a cleft lip, cleft palate or clubfoot.

Lamotrigine is an antiepileptic used as monotherapy or in combination with other drugs to control seizures and to prevent mood swings for patients with bipolar disorder. Helen Dolk, PhD, study author, described that some studies have shown lamotrigine to increase the risk of cleft lip or palate whereas some have not. 

RELATED: Lamotrigine Monotherapy in Epilepsy: What’s the Optimal Dose?

For this study, Dr. Dolk and colleagues studied over 10 million births over a 16-year period. Of the 226,806 babies with birth defects, 147 babies were exposed to lamotrigine within the first trimester of pregnancy and had non-genetic birth defects. The risk of babies with a cleft lip, cleft palate or clubfoot was not significantly higher than babies with other birth defects who were exposed to lamotrigine in the first trimester.

Study authors estimated the risk of cleft lip or cleft palate among babies exposed to lamotrigine to be less than 1 in every 550 babies. “We recommend that for all mothers with epilepsy, whatever their drug exposure, special attention be given to examining the baby for cleft palate.” More studies are needed, especially of high doses of lamotrigine, they concluded. 

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