FDA Warns that Topamax May Increase Risk of Oral Birth Defects

According to the Food and Drug Administration, babies born to moms who used Topamax while pregnant are at greater risk of being born with a cleft palate or a cleft lip. The government agency says that medical professionals should warn patients in the childbearing age range that the drug, used to treat epileptic seizures and prevent migraine headaches, could cause oral birth defects. If your child was born with a cleft palate and you were taking Topamax (or one of its generic versions) while pregnant, you should contact our Owing Mills products liability lawyers right away.

Data from the North American Antiepileptic Drug (AED) Pregnancy Registry shows that the risk or oral clefts can go up if the baby is exposed to Topamax (topiramate) during the first trimester of pregnancy. Exposure to topiramate as a single therapy upped the prevalence of oral clefts by 1.4%. The prevalence for infants exposed to other antiepileptic drugs was .38-.55%. The prevalence for infants of moms who did not take any antiepileptic medication was .07%.

FDA says topiramate should be accompanied by a stronger warning and it will now fall under the Pregnancy Category D, which indicates a positive evidence of human fetal risk. However, a person currently taking the drug shouldn’t stop without first talking to his or her doctor.

The Cleft Palate Foundation says that 6,800 babies with an oral birth defect annually. That’s one out of every 594 newborns.

Not only can a cleft palate severely alter someone’s appearance, but it can also result in speech defects, teeth misalignment, ear infections, digestion problems, and feeding issues. A child may have to undergo multiple surgeries to repair the birth defect. Costly speech therapy and orthodontic work may also be required.

FDA: Risk of oral birth defects in children born to mothers taking topiramate, FDA, March 4, 2011
Topamax, NIH.gov
Related Web Resources:

Cleft Palate Foundation


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