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FDA Warning: Topamax® Can Cause Cleft Lip and Palate

The antiepilepsy drug Topamax® (topiramate) has been found to increase the risk of cleft lip and cleft palate in babies when their pregnant mothers take the drug. Topamax® harms the fetus early in the first trimester of pregnancy when the lips and palate are being formed, keeping these parts of the face from closing completely.

The U.S. Food and Drug Administration (FDA) released this information March 4, 2011.

The defects can range widely from being just a small notch in the lip to a groove that runs from the lip into the top of the mouth (the soft palate) and the nose. When the defect is more extreme, it can cause problems with speech and eating and lead to infections in the ears. The problems usually can be successfully corrected with surgery.

The data indicating the increased risk of taking Topamax® during the early first trimester of pregnancy come from the North American Antiepileptic Drug Pregnancy Registry. The data showed the prevalence of cleft lip or palate were:

• 1.4 percent in fetuses exposed to Topamax®
• 0.38 to 0.55 percent in fetuses exposed to other antiepileptic drugs
• 0.07 percent in infants of mothers who did not have epilepsy and were not treated with antiepileptic drugs

Data from the United Kingdom Epilepsy and Pregnancy Register coincided with the data from the North American registry.

FDA Strengthens Topamax® Warning Label

Because of these new data, the label on Topamax® will have a stronger warning about the dangers of taking the drug during pregnancy. In addition, the pregnancy category of Topamax® will change from Pregnancy Category C to Pregnancy Category D. The new safety warning will also appear in the patient medication guide and prescribing information for Topamax® and generic versions of the drug.

Pregnancy categories are applied to drugs to indicate the level of risk they pose to the unborn child. The category that will now be applied to the Topamax®, Pregnancy Category D, means that there is positive evidence of human fetal risk.

This determination is based on data that show there is an adverse reaction from research or marketing experience or studies in humans. Pregnant women may still use drugs in this category if the potential benefits outweigh the risks. This will be determined by a doctor.

Pregnancy Category C drugs, to which Topamax® previously belonged, have been shown in animal reproduction studies to have an adverse effect on the fetus, but no adequate or well-controlled studies in humans support this finding. Category C states the potential benefits of the drugs may warrant their use in pregnant women despite the potential risks.

What Should You Do?

The FDA announcement advises pregnant women and women of childbearing age to talk with their doctors about other treatment options. If a woman is pregnant or is planning to become pregnant, she should speak to her doctor about that also.

The FDA suggests that women who become pregnant while taking Topomax® talk to their health care provider about registering with the North American Antiepileptic Drug Pregnancy Registry. The registry collects information about the births of babies born to women being treated during their pregnancies with antiepileptic medications.

For more information, contact a Topamax® birth defect attorney today.

"Topamax® May Cause Birth Defects, Says FDA"

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