Petach Tikva, Israel—Pharmacists can share some comforting news with expectant mothers with epilepsy: Taking lamotrigine during pregnancy does not increase the risk of birth malformations or neurodevelopmental disorders. 

That’s according to an article in The British Journal of Clinical Pharmacology. The Israeli study is touted as the most extensive long-term report on how children fared when their mothers took lamotrigine during pregnancy.

Research led by the Schneider Children’s Medical Center included the children of 83 epileptic women treated with lamotrigine during pregnancy at a tertiary medical center between 2004 and 2014. Results were based on monitoring of the newborns, including vital signs, congenital malformations and Finnegan score, as well as a questionnaire provided to parents regarding their child’s development and health up to the age of 12 years.

The researchers identified no major malformations in the newborns, nor did any of the infants have significant withdrawal symptoms as measured by Finnegan score. At follow-up at age 12, with 56.6% of the participants aged 6 to 12 years at the time of evaluation, no significant evidence was discovered in the incidence of neurodevelopmental disorders.

“According to our experience, lamotrigine is generally safe for pregnancy use, associated with minimal short-term complications with no long-term effects on the outcome,” study authors conclude.

“The results of this study are good news for both pregnant epileptic women and their children, as well as their treating neurologists,” added coauthor Itai Berger, MD, of the Hadassah-Hebrew University Medical Center in Jerusalem.

A study published last year in the journal Neurology also found that babies born to pregnant women taking lamotrigine appeared not be at an increased risk of birth defects, such as cleft lip, cleft palate or clubfoot.

That study emphasizes that maintaining effective epilepsy treatment during pregnancy is important because seizures could harm the fetus.

“An initial study of this drug showed an increased risk for cleft lip or cleft palate, but a number of other studies since have not, and a previous study showed an increased risk of clubfoot,” said study author Helen Dolk, PhD, of Ulster University in Northern Ireland, UK. “This particular study had a much larger population size more than double the size of the previous study.”