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Topamax, Alternatives, and the Risk of Oral Birth Defects

Topamax, a drug used to treat epilepsy, may put unborn babies at an increased risk of oral birth defects. The Food and Drug Administration says mothers-to-be who take Topamax or its generic form are approximately twenty times more likely to give birth to infants that develop cleft palate or cleft lips than mothers who do not take Topamax.

Cleft lips are rare in the U.S., and they occur when a baby’s mouth does not completely form. This causes what looks to be a split in the person’s lip. Cleft palate is also rare in the U.S., and it is described as a hole in the roof of a person’s mouth. Both of these conditions may lead to numerous developmental problems, as they can cause difficulties in obtaining sufficient nutrition.

Experts advised physicians to warn female patients who are of childbearing age to be aware of the risks of Topamax. The defects manifest during the first trimester of pregnancy, sometimes before women realize they are pregnant.

Russell Katz is the head of the FDA’s Division of Neurology Products. Katz said that doctors should carefully consider the risks before prescribing the medication to women who are of childbearing age. He said that physicians should consider alternative medicines with lower risks of birth abnormalities.

The Food and Drug Administration issued the warning after the North American Antiepileptic Drug Pregnancy Registry collected data concerning the drug’s harmful risks. According to the data, cleft palates and lips occurred in approximately 1.4 percent of infants exposed to the drug or its generic alternatives compared to only about 0.38 percent and 0.55 percent in babies whose mothers consumed other epilepsy drugs. It is estimated that the defect occurs in approximately 0.07 percent of babies whose mothers do not take any of these medications.

Vivus Incorporated said that the warning does not affect the Food and Drug Administration’s currently pending review of Qnexa, an experimental drug prescribed for weight loss. Qnexa combines topiramate (generic Topamax) with phentermine, an appetite suppressant.

In January 2011, Vivus said that the Food and Drug Administration wanted Vivus to assess the feasibility of analyzing data to ascertain the risks for cleft palate and cleft lip in babies affected by mothers who took Topamax. Some experts speculated that the United States may not approve Qnexa in 2011. The delay caused significant declines in the company’s share price.

Johnson & Johnson said that the label on Topamax already warns users of the risks in pregnancy. According to J&J, they will work with the Food and Drug Administration to clearly explain issues related to Topamax during pregnancy.

Topamax brings in millions of dollars in revenue. At its high point, Topamax brought in $2.7 billion in the year 2008, but that was before its rivals became available in 2009. Several drug makers, including Watson Pharmaceuticals, Inc., Teva Pharmaceutical Industries Ltd, and Mylan Inc. offer the drug for sale under the name topiramate, which is the chemical name for the medication.

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