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The epilepsy drug Topamax (topiramate) and its generic versions can increase the risk of oral birth defects (cleft lip and cleft palate), warns the Food and Drug Administration (FDA).

Data compiled by the North American Antiepileptic Drug (AED) Pregnancy Registry, shows a greater risk of oral clefts in infants exposed to Topamax and generic versions, during the first trimester. Infants exposed to this drug as a single therapy had a 1.4 percent rate of mouth defects, which is three times more than seen with other antiepileptic drugs.

The agency has raised the drug’s pregnancy category from C to D, which means there is evidence the drug can harm a human fetus, but there are situations where the drug’s benefits to the mother could outweigh its risks.

The patient medication guide and prescribing information for Topamax and generic topiramate will be updated with the new information.

The FDA approved Topamax for the treatment of seizures and migraine headaches; however, the drug is also prescribed to teat other ailments through off-label prescriptions.

The FDA suggests that women who become pregnant while taking Topamax should take to their doctor about registering with the North American Antiepileptic Drug (AED) Pregnancy Registry, a group that collects information about the outcomes of infants born to women treated with this class of drugs during their pregnancy.

Also read the FDA Drug Safety Communication. And for more information on cleft lip and cleft palate, visit the Cleft Palate Foundation.

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