The palate is the roof of the mouth. The soft palate is at the back of the mouth, and the hard palate is at the front. During fetal development, until the sixth week of the mother's pregnancy, the palate of all fetuses is cleft or split down the midline of the fetus' face.

From the sixth to the eleventh week of pregnancy, the two sides of the palate come together to form a single structure. If this fusion fails or is only partially complete, the infant is born with a cleft palate, a cleft lip, or both.

Cleft lip, cleft palate, or both are called oral clefts. They are facial and oral malformations that can affect a baby's speech, eating ability and hearing.

Topamax® Linked to Cleft Palate & Cleft Lip

A failure to fuse can be caused by a number of factors that interfere with a fetus' development. Topamax®, an antiseizure medication, has been found to interfere with development at this stage of fetal life.

Topamax® is prescribed for treating certain types of epileptic seizures. If an epileptic pregnant woman takes Topamax® in the first trimester of her pregnancy, there is a significant chance her baby will be born with a cleft lip, cleft palate, or both. Oral clefts are the most common birth defects above the neck in infants.

The U.S. Food and Drug Administration (FDA), after a recent review of statistics on Topamax® and birth defects, issued a warning about the drug's potential to cause birth defects when taken by pregnant women. The statistics compared babies of mothers who took Topamax® with babies of mothers who took another antiepileptic medication and babies of mothers who didn't take an antiepileptic medication at all.

The data showed:

• 1.4 percent of infants born to mothers taking Topamax® had oral clefts
• 0.38 to 0.55 percent of infants born to mothers taking other antiepileptic medications had oral clefts
• 0.07 percent of babies born to mothers who were not epileptic and were not taking any antiseizure medication were born with oral clefts

Results from the United Kingdom supported the U.S. data. The UK Epilepsy and Pregnancy Register showed babies born to mothers taking Topamax® had a 3.2 percent risk of developing oral clefts. This was a risk 16 times greater than that of the general population.

Because Topamax® was clearly shown to be teratogenic (causing defects in fetal development), the FDA also changed the pregnancy category of the drug. Previously, Topamax® had been classified as a Category C drug. That means animal studies showed it could cause birth defects. The FDA changed that to a Category D drug, meaning the drug was shown to cause birth defects in humans.

If your baby is born with cleft lip or palate, contact a Topamax® birth defect lawyer at AWKO law by calling (888) 255-AWKO (2956).