March 4, 2011—The FDA announced that Topamax may increase the risk for birth defects in children born to women who are given the medication during pregnancy. Data compiled by the North American Antiepileptic Drug (AED) Pregnancy Registry reveals an increased risk of oral clefts in infants exposed to Topamax and its generic versions during the first trimester.
Cleft lips and cleft palates occur when the mouth does not form properly, resulting in either a split lip or a hole in the roof of the mouth. The condition typically requires multiple surgeries to correct and can lead to developmental issues due to the child's inability to get adequate nutrition.
The risk is of cleft lip and cleft palate is significant, with approximately 1.4% of infants developing the condition when exposed to the drug during the first trimester of pregnancy. This represents a risk up to 16 times greater than similar drugs.
The FDA has re-classified Topamax as a Class D drug to signify that there is positive evidence of fetal risk based on human data. It previously was identified as a Class C drug after birth defects were demonstrated in animal testing.
Topamax predominately is prescribed for treatment of seizures associated with epilepsy and for severe migraines. The drug is manufactured by Ortho-McNeil-Janssen Pharmaceuticals, Inc., a division of Johnson & Johnson. |
