High Incidences of Cleft Lip and Cleft Palate Birth Defects Prompt FDA to Issue Warning
Topamax, a drug prescribed to treat epilepsy as well as help prevent migraines, has been linked to severe birth defects including cleft lip and cleft palate. Topamax, also known by its generic name, topiramate, increases the rate of oral cleft birth defects from 0.07% to 1.4%. On March 4, 2011, the Food and Drug Administration issued a warning to providers and patients of the higher incidence of birth defects. Seeger Weiss is currently investigating the connection between Topamax and birth defects.
Cleft lip and cleft palate are two kinds of birth defects known as “oral clefts.” Oral clefts occur when parts of the lip, and sometimes the roof of the mouth and bottom of the nose, do not fully meet during development in the uterus. As a result, children are born with a cleft, or gap, that can be as small as a notch on the lip, to a grooved space that extends from the lip, into the palate and nose. While the majority of cases are resolved with reconstructive surgery, some severe cases of cleft palate lead to problems with eating, talking, and ear infections. Normally, the upper lip and palate meet and fuse together during the first trimester of pregnancy, a time unfortunately when many women do not yet realize they are pregnant. As a result, some mothers are unable to prevent exposure to Topamax until later in their pregnancies, when the oral cleft birth defect has already formed.
The North American Antiepileptic Drug (AED) Pregnancy Registry recently released new data that prompted the FDA’s warning. Their statistic show that, while children born to mothers who do not have epilepsy and are not taking an anti-epileptic drug suffer oral clefts only 0.07% of the time, babies born to mothers taking Topamax experience cleft lip and cleft palate at a rate of 1.4%. Children whose mothers have epilepsy, and are taking a drug other than Topamax or containing topiramate, have an incidence of 0.38-0.55% of oral clefts.
The FDA cited statistics from the North American Antiepileptic Drug (AED) Pregnancy Registry in their warning. The data indicates an increased risk of oral clefts in babies exposed to Topamax (topiramate) during the first trimester of pregnancy. 1.4% of children whose mothers’ took Topamax suffered from oral clefts, compared with 0.38– 0.55% of children whose mothers’ took other anti-epileptic drugs. Only 0.07% of children whose mothers do not have epilepsy and are not taking anti-epileptic drugs suffer from left lips or cleft palates.