FDA: Topiramate (Topamax) Tied to Risk of Oral Clefts

Higher risk of cleft lip and cleft palate in infants exposed to topiramate during first trimester

FRIDAY, March 4 (HealthDay News) -- The U.S. Food and Drug Administration has notified health care providers and consumers that new data indicate that women who take topiramate (Topamax) during pregnancy increase the risk for cleft lip and cleft palate in their offspring.

Topiramate is indicated for the treatment of certain types of seizures in individuals with epilepsy. The drug is also indicated for the prevention of migraine headaches, but not to relieve the pain of migraines. Data from the North American Antiepileptic Drug (AED) Pregnancy Registry show an elevated risk of cleft lip and cleft palate in infants exposed to topiramate during the first trimester of pregnancy.

Compared to infants exposed to other antiepileptic drugs, those exposed to topiramate as a single therapy experienced a higher prevalence of oral clefts (1.4 versus 0.38 to 0.55 percent). The data also indicate that infants of mothers who did not have epilepsy and were not being treated with other antiepileptic drugs had a prevalence of 0.07 percent. Data from the United Kingdom Epilepsy and Pregnancy Register support this data.

According to the FDA, "based on the data, topiramate will have a stronger warning in its prescribing information (labeling). The pregnancy category will be changed to Pregnancy Category D. This means that there is positive evidence of human fetal risk based on human data, but the potential benefits of the drug in pregnant women may outweigh the risks in certain situations. The FDA previously designated the drug as Pregnancy Category C because of the lack of human data."

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