New data show an increased risk of cleft lip and cleft palate in infants born to women who took Topamax (topiramate) during pregnancy, according to the Food and Drug Administration (FDA).
The new data were obtained from the North American Antiepileptic Drug Pregnancy Registry.
Topiramate is an anticonvulsant approved for use alone or with other medications to treat patients with epilepsy who have certain types of seizures, as well as to prevent migraine headaches.
The drug now is being classified as “Pregnancy Category D” as a result of the positive evidence of fetal risk based on human data, though potential benefits from use of the drug in pregnancy may be acceptable in certain situations, the FDA noted in a MedWatch report. The patient medication guide and prescribing information for topiramate will be updated.
Pregnant women and those of childbearing potential should discuss other treatment options with their health care professionals....