Topamax is a prescription drug used to treat patients with epilepsy and prescribed to adults to prevent migraines. On March 4, 2011, the Food and Drug Administration (FDA) identified Topamax as a Pregnancy Category D drug, which means there has been evidence of human fetal risk. It specifically increases the risk of cleft birth defects such as cleft palate and cleft lip in infants whose mothers consumed this drug during their first trimester of pregnancy. Cleft palate and cleft lip develop when a section of the palate or lip does not fuse together properly. As a result, a notch in the lip can form (cleft lip) or a groove in the roof of the mouth and nose can form (cleft palate). These facial defects can cause problems with eating, speaking and possible ear infections. Corrective surgery is almost always used to treat this condition.
According to recent statistics, these defects are sixteen (16%) more likely to occur in mothers who take this drug during their pregnancy. Although Topamax is one of the highest selling prescription drugs in the United States, it is advised that women who are pregnant or plan to become pregnant discuss alternative treatment options with their physician. Those who currently take this medication should also consult with their health care professional before terminating its use. Topamax will continue to be sold, but due to recent information, it will now have a stronger warning label.