The FDA has announced that there is an increased risk of oral birth defects in children born to women taking Topamax during pregnancy. Data collected from a registry of pregnant women revealed a higher risk of cleft lip and cleft palate in infants whose mothers were being treated with Topamax or the generic Topiramate during pregnancy.

Topamax Birth Defects

According to information from the North American Antiepileptic Drug Pregnancy Registry, 1.4% of infants exposed to topiramate during pregnancy developed a cleft palate or cleft lip, whereas only .38-.55% of infants exposed to other epilepsy drugs developed an oral birth defect. Furthermore, the risk of oral birth defects was much lower (.07%) among children born to mothers who were not taking epilepsy drugs, such as Topamax, during pregnancy.

Cleft lip and cleft palate are types of topiramate birth defects which affect the upper lip and roof of the mouth. These Topamax birth defects develop when parts of the lip or palate do not fuse together during the first three months of pregnancy. The oral birth defects can range from a small notch in the lip to a groove which extends into the roof of the mouth and nose. Topamax birth defects can alter the child's face and may lead to difficulty eating and talking, as well as ear infections. Treatment for Topamax cleft palate and cleft lips typically involves corrective surgery.

Topamax Pregnancy Warning

In response to the data regarding Topamax birth defects, the FDA will strengthen the product label on Topiramate, a drug used to treat seizures associated with epilepsy and prevent migraines. The Topamax pregnancy warning has been updated from a category C to a category D risk, meaning that there is positive evidence of fetal risk based on human data.

The FDA warns that women of childbearing age and pregnant women should speak with their doctors about other treatment options to avoid taking Topamax or topiramate during pregnancy. Due to the risk of potential Topamax side effects during pregnancy, women should tell their doctor immediately if they become pregnant or plan to become pregnant while taking topiramate. However, people taking Topamax should not stop the drug unless instructed to do so by their physician.

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