The Food and Drug Administration (FDA) indicates an increased risk of cleft lip and palate while taking topiramate during pregnancy.
Topiramate is used to treat epilepsy and for migraine prophylaxis. An increased risk of cleft lip and cleft palate in newborns is especially when taken in the first trimester of pregnancy. The prevalence is 1.4% according to FDA topiramate - compared to 0.38 to 0.55% for the use of other antiepileptic drugs and 0.07% in women not taking such drugs.
leaflet and SPC will be complemented with appropriate instructions.
Source:
Safety Information the FDA of 4 March 2011
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