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Risk of oral clefts in the offspring after first trimester exposure to Topiramate

Topiramate ( Topamax ) is an increasingly used drug during childbearing ages for treatment of epilepsy, migraine, and appetite suppression as well as for off-label indications such as sleep and psychiatric disorders.

While some reports suggested an increased risk of oral cleft ( OC ), these reports are balanced by studies that could not confirm such association.

Researchers conducted a meta-analysis of all studies reporting on women exposed to Topiramate during pregnancy. Of the 2327 publications reviewed, 6 articles met the inclusion criteria including 3420 patients and 1,204,981 controls.

The odd ratio ( OR ) of oral cleft after the first trimester exposure to Topiramate exposure was 6.26 ( 95% confidence interval: 3.13-12.51; P=0.00001 ).

This study has provided strong evidence that Topiramate is associated with an increased risk of oral cleft in infants exposed to Topiramate during embryogenesis and should lead to a careful review of Topiramate use in women of reproductive ages. ( Xagena )

Alsaad AM et al, Reprod Toxicol 2015; Epub ahead of print