Topamax (generic Topiramate) is associated with an increased risk of major birth defects among infants whose mothers took the drug during pregnancy, especially in the first trimester. These include cleft palates, cleft lips and genital defects, among others.
Cleft lip and palate are congenital abnormalities of the upper lip and the hard and soft palate of the mouth. The condition ranges from a small indentation in the lip to a broader crease extending into the roof of the mouth and nose. Any or all of these characteristics may occur in the same individual.
Various complications are associated with cleft lip and palate including problems with feeding, speech, breathing, sleep, infection and teeth. Surgical correction is appropriate in most cases, and should be timed to each individual's facial growth. Consultations with dental and cosmetic surgeons are advisable.
In 2008, a study report by the UK Epilepsy and Pregnancy Register revealed a higher than usual rate of congenital malformations for infants who were exposed to Topiramate in the mother's first trimester of pregnancy. Oral clefts were 11 times more likely than the previously reported average of 1 in 500 births. Similarly, for hypospadias, the observed rate was 14 times higher than the background rate of 1 in every 300 live births.
On March 4, 2011, a study conducted by the North American Antiepileptic Drug Pregnancy Registry (NAAED) concluded that infants exposed to Topamax and Topiramate experienced a 1.4 percent rate of oral defects, which was more than three times greater than that seen with other seizure medications. The frequency of these defects in women not taking any epilepsy medication is .07 percent.
As a result of these data, the federal Food and Drug Administration (FDA) has moved Topamax to a Category D pregnancy status, which places women at high risk for developing serious birth defects. Johnson & Johnson is required to change the drug's label to reflect the birth defect risk. |
