Topiramate: Risk of Oral Clefts in Newborns

Drug Alerts , News / September 21, 2016

Based on data obtained from the North American Antiepileptic Drug (NAAED) Pregnancy Registry, the FDA advised healthcare professionals and patients of an increased risk of development of cleft lip and/or cleft palate (oral clefts) in infants born to women treated with topiramate during pregnancy.

Based on this data, topiramate is to be placed in Pregnancy Category D, which means that there is positive evidence of human fetal risk based on human data, but the potential benefits from use of the drug in pregnant women may be acceptable in certain situations despite its risks. The patient medication guide and prescribing information for topiramate–containing medications will be updated with the new information.

Topiramate is an anticonvulsant medication approved for use alone or in combination with other medications to treat epileptic patients who have certain types of seizures. It is also approved for use in prevention of migraine headaches.

Before initiating topiramate, pregnant women and women of childbearing potential should discuss other treatment options with their healthcare professionals. Women taking topiramate should inform their healthcare professional immediately if they are planning to or become pregnant. Patients taking topiramate should not stop taking the medication unless told to do so by their healthcare professional.

Topiramate is available under the tradename Topamax.

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