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Epilepsy Drug Topiramate Linked to Cleft Palate, Cleft Lip


The epilepsy drug topiramate (Topamax and generics) has been associated with an increased risk of cleft palate and cleft lip in infants born to women who take the drug during pregnancy. According to a statement from the Food and Drug Administration (FDA), the drug’s labeling will be changed to reflect this warning.

Topiramate is used to treat epilepsy and migraine

Topiramate is an anticonvulsant that works by reducing abnormal excitement in the brain. Physicians prescribe topiramate alone or along with other medications to treat certain types of seizures in people who have epilepsy, as well as to control seizures associated with Lennox-Gastaut syndrome and to prevent migraine headaches. The drug is also prescribed to treat bipolar disorder, to enhance psychotrophics, and to help prevent weight gain associated with some antidepressants.

The new warning comes after analysis of data from the North American Antiepileptic Drug Pregnancy Registry, which indicated an increased risk of cleft palates and cleft lips in infants exposed to topiramate during the first trimester. Palate formation begins at the end of the fifth week of gestation.

Oral clefts include cleft lip and cleft palate, the most common birth defects in the United States. One of every 600 newborns is affected by cleft palate and/or cleft lip, according to the Cleft Palate Association. A cleft lip is a separation of the two sides of the lip, while a cleft palate is an opening the roof of the mouth in which the two sides of the palate do not join together.

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The data showed that infants exposed to topiramate as the only treatment experienced a 1.4 percent prevalence of oral clefts compared with a prevalence of 0.38 to 0.55 percent in infants who were exposed to other anticonvulsant medications. Among infants born to women who did not have epilepsy and who were not taking antiepileptic drugs, the prevalence of oral clefts was 0.07 percent.

Because of this new information, Topamax and generic topiramate will now be categorized as Pregnancy Category D rather than Pregnancy Category C drugs. A Category D means there is positive evidence of human fetal risk based on human data, and that the potential risks of using the drug by women who are pregnant may outweigh the benefits in certain situations.

Russell Katz, MD, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research stated that “Health care professionals should carefully consider the benefits and risks of topiramate when prescribing it to women of childbearing age.”

Women who are taking topiramate and become pregnant should contact their physician immediately, as alternative medications that have a lower risk of birth defects are available. Pregnant women may also ask their doctor about registering with the North American Antiepileptic Drug Pregnancy Registry, which collects data regarding infants born to women who have been taking antiepileptic drugs during pregnancy.

Food and Drug Administration