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Lamotrigine in Pregnancy Not Linked to Certain Birth Defects

Excess risk of orofacial cleft estimated to be less than one in every 550 exposed babies


THURSDAY, April 7, 2016 (HealthDay News) -- Despite initial concern from early studies, taking the epilepsy drug lamotrigine during pregnancy may not raise the risk for certain birth defects, according to a study published online April 6 in Neurology.

Helen Dolk, Dr.P.H., of Ulster University in Northern Ireland, and colleagues analyzed data on more than 10 million births over 16 years, including 226,806 infants with birth defects. Among those infants were 147 whose mothers took lamotrigine during the first trimester of pregnancy and had nonchromosomal congenital anomalies (CA).

The researchers found that the adjusted odds ratio (aOR) for all orofacial anomalies was 1.31 (95 percent confidence interval [CI], 0.73 to 2.33). For isolated orofacial cleft, the aOR was 1.45 (95 percent CI, 0.80 to 2.63), and the aOR for isolated cleft palate was 1.69 (95 percent CI, 0.69 to 4.15). The overall aOR for clubfoot was 1.83 (95 percent CI, 1.01 to 3.31), and it was 1.43 (95 percent CI, 0.66 to 3.08) in the independent study population. Lamotrigine monotherapy was not significantly associated with other specific CA.

"The risk of orofacial cleft was not significantly raised and we estimate the excess risk of orofacial cleft to be less than one in every 550 exposed babies," the authors write. "We have not found strong independent evidence of a risk of clubfoot subsequent to our original signal. Our study cannot assess the general malformation risk among lamotrigine-exposed pregnancies."

The study was funded by GlaxoSmithKline, the manufacturer of lamotrigine.

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