March 4, 2011—The FDA warned that Topamax (Topiramate) may increase the risk of birth defects in children born to mothers who take the drug during pregnancy. The announcement followed research conducted by the North American Antiepileptic Drug (AED) Pregnancy Registry that revealed an increased incidence of cleft palate and cleft lip with infants exposed to Topamax and its generic version, Topiramate.
According to the data, approximately 1.4% of infants developed either cleft lip or cleft palate when exposed to Topamax or Topiramate during the first trimester of pregnancy. This represents a risk approximately sixteen times greater than other antiepileptic drugs.
The risk of birth defects prompted the FDA to classify Topamax as Class D drugs, reflecting that there is positive evidence of fetal risk based on human data. The drug previously was classified as Class 7 after risks were uncovered during animal testing.
Topamax is manufactured by Ortho-McNeil-Janssen Pharmaceuticals, Inc., a division of Johnson & Johnson, and is prescribed for treatment of seizures associated with epilepsy. It also is prescribed for treatment of severe migraines.