Topamax®, an antiepileptic medication, may cause birth defects, according to the U.S. Food and Drug Administration (FDA). The drug is prescribed to treat certain types of seizures in epilepsy patients and to prevent migraines. It is not used to treat migraines once they have begun, however.
After reviewing data gathered by the North American Antiepileptic Drug Pregnancy Registry, the FDA said a significant percentage of infants were born with cleft lip and/or cleft palate, compared to infants exposed as fetuses to other antiepileptic drugs or to infants not exposed to any antiepileptic drugs at all.
The statistics showed that 1.4 percent of babies of mothers taking Topamax® were born with cleft lips, palates, or both.
The registry collects information on the births of babies born to woman taking epileptic medications. Doctors are asked to encourage pregnant epileptic patients to contact the registry. Data from the United Kingdom supported the U.S. registry information.
The drug’s manufacturer, Ortho-McNeil Neurologics, is being required to add the information to the drug’s label. Women who are pregnant or want to become pregnant should talk to their doctors before taking the medication. Healthcare professionals are advised to consider prescribing alternative anti-seizure medicine to these patients.
As a result of the new findings, the FDA is changing the pregnancy category of the drug to a Category D drug from a Category C. Category C drugs have been shown to cause birth defects in animal studies. Category D drugs are known to cause birth defects in humans.
Cleft lip or cleft palate or both are known are oral clefts. They are the most common type of facial birth defect. The cleft, or separation, can be as small as a tiny notch in the upper lip. Or, it can be a separation of the upper lip that runs through the palate (roof of the mouth) to the nose.
Ortho-McNeil Neurologics, headquartered in Titusville, New Jersey, is a division of Ortho-McNeil Janssen Pharmaceuticals, a Johnson & Johnson company.
