The FDA has placed the anticonvulsant drug Topamax, and its generic equivalent topiramate, in Pregnancy Category D as a result of new data illustrating an increased risk of the development of cleft lip and/or cleft palate (oral clefts) in infants born to women treated with Topamax during the first trimester of pregnancy. The data showed a Pregnancy Category D means that there is positive evidence of fetal risk based upon human data. Topamax is manufactured by Ortho-McNeil-Jannsen and has been marketed in the United States for almost 15 years for the treatment of some patients with epilepsy and for the prevention of migraine headaches. In addition, it has been used off-label for other conditions, many of which are not considered serious. Over four million (4,000,000) patients have filled prescriptions for Topamax and/or topiramate in the United States over the last four years.
All patients of child-bearing age who are taking topiramate should immediately discuss the risks and benefits of continuing treatment with their physicians, particular because oral clefts occur early in pregnancy, prior to most women even becoming aware that they are pregnant. Certainly, as with any drug carrying a Category D Pregnancy label, women should only take it for conditions that are life threatening. There are other, less risky, options available for many child-bearing women. Still, topiramate should not be stopped without speaking with a doctor because immediately stopping treatment can also carry serious risks.
The data showed a risk of 1.4% of oral clefts in the topiramate population compared to .38% – .55% in infants exposed to other antiepileptic drugs.
Cleft lip and cleft palate birth defects can range from a small notch in the lip to a more serious groove that runs into the roof of the mouth and nose – causing issues with eating and speech. Surgery is often used to close the lip and palate, and most children do well.
While Ortho-McNeil-Jannsen, a subsidiary of Johnson & Johnson, is updating their label to reflect this risk, I hope that it takes the time and effort to contact doctors and patients immediately and directly.