Topamax Birth Defects: Another Drug for Pregnant Women to Watch For?

Washington, DCWith news that the US Food and Drug Administration was releasing a warning about the risk of Topamax birth defects, pregnant women may have wondered if there is any medication that is safe for them to take while pregnant. Not only did the FDA release a warning about the risk of serious Topamax side effects, the agency also announced it was changing the severity of the Topamax pregnancy category. Women have been warned that they should carefully weigh the risks of Topamax and topiramate side effects.

Topamax, known generically as topiramate, was previously in Pregnancy Category C, meaning that there was evidence from animal studies that the fetus faced a potential risk from exposure to the drug but that the risk had not been adequately proven in human trials or studies when the drug was approved. The FDA has now moved topiramate into Pregnancy Category D, meaning there is evidence of human fetal risk.

Complicating the situation for pregnant women is that the birth defect in question, oral cleft, happens early in pregnancy, sometimes before the woman realizes she is pregnant. This means that any woman of childbearing age who takes Topamax must consider whether or not it is worth the risk.

"The benefits and risks of topiramate should be carefully weighed when prescribing this drug to women of childbearing age, particularly for conditions not usually associated with permanent injury or death," a spokesperson for the FDA said. "Alternative medications that have a lower risk of oral clefts and other adverse birth outcomes should be considered for these patients."

Furthermore, if women of childbearing age choose to use Topamax, they should use effective birth control, the FDA warns.

The FDA's announcement was based on data from the North American Antiepileptic Drug (NAAED) Pregnancy Registry. That data suggested an increased risk of oral cleft in infants who were exposed to topiramate during the first trimester. In infants exposed to topiramate, the incidence of oral cleft was 1.4 percent, compared with an incidence of 0.38 percent to 0.55 percent in infants who were exposed to other antiepileptic drugs, and 0.07 percent in infants of mothers who did not have epilepsy or were not treated with an antiepileptic drug.

Cleft lip and cleft palate can usually be treated with surgery. Prior to surgery, however, the infant can have difficulty with eating and talking.