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FDA Warning Regarding Topamax®

The U.S. Food and Drug Administration (FDA) announced March 4, 2011, that the anti-seizure medication Topamax® (topiramate) was found to increase the risk of an infant being born with cleft lip and/or cleft palate if its mother took the medication during the first trimester of pregnancy.

The FDA based its announcement on data gathered by the North American Antiepileptic Drug Pregnancy Registry. The statistics indicated that 1.4 percent of babies born to mothers taking Topamax® were born with oral clefts (cleft lip, cleft palate, or both). This compares with a prevalence of oral clefts of 0.38 to 0.55 percent of infants born to mothers taking other anti-seizure drugs and 0.07 percent prevalence of infants born to mothers who were neither taking antiepilepsy medications nor were epileptic.

For Patients

If a woman becomes pregnant or intends to become pregnant and is taking Topamax®, she should speak with her doctor as soon as possible, according to the FDA announcement. She should not suddenly stop taking the medication without the doctor’s advice though. Seizures can be very harmful to a pregnant woman and her developing fetus. In addition, women of childbearing age should take contraceptives while on Topamax®.

The pregnancy category of the medication was also changed by the FDA, from Category C to category D. Category D drugs have been shown to harm human fetuses, but are not absolutely contraindicated (undesirable) during pregnancy if the benefits are thought to outweigh the risks. Alternative drugs should be considered, however.

Cleft Lip and Palate

The lips and palate (roof of the mouth) are cleft or separated in the middle of the face in the growing fetus until they begin coming together during the sixth through the 12th weeks of fetal development. If the pregnant mother takes Topamax® during this time, the drug can sometimes interfere with that fusion process.

Other substances or circumstances that can cause oral clefts include:

• Having a family history of oral clefts
• Smoking during pregnancy
• Drinking alcohol during pregnancy
• Taking illegal drugs (such as cocaine) during pregnancy
• Exposure to radiation when pregnant
• Having an infection during the first trimester of pregnancy

Oral clefts are the most common malformation of the head and neck of an infant. The cleft (or separation) may be a small notch in the upper lip that is barely noticeable. Or it can be as large as a significant groove that extends into the roof of the mouth and nose.

Surgery is the primary treatment for oral clefts. Often, multiple surgeries are necessary. Other types of treatment the child often needs include dentistry, orthodontics, and help from speech and hearing pathologists, specialists in feeding, and psychologists.

If you took Topamax® during your pregnancy and your baby is born with cleft lip or palate, contact our Topamax birth defect attorneys for help. You might be eligible for compensation.

"Topamax® May Cause Birth Defects, Says FDA"

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