Topamax Concerns Addressed by the FDA - Consumer Justice Foundation

Topamax Concerns Addressed by the FDA

Written by Faith Anderson on April 14, 2011


FDA Elevates the Topamax Pregnancy Category

On March 4, 2011, the FDA informed consumers that, according to new data, infants born to women who take topiramate (Topamax) while pregnant have a significantly increased risk of developing cleft lip or cleft palate (Source: This data was collected by the North American Antiepileptic Drug (NAAED) Pregnancy Registry and reviewed by the FDA, and directly influenced the FDA’s decision to increase the pregnancy category of Topamax from C to D. The FDA reserves category D for drugs which positive human evidence has shown can cause severe harm to a fetus when taken during pregnancy.

Topamax and Birth Defects Research

According to the information collected by the NAAED Pregnancy Registry, infants whose mothers took Topamax during pregnancy were twenty times more likely to be born with a cleft lip or cleft palate than infants not exposed to any anticonvulsant drugs in utero, and three to four times more likely to develop an oral cleft than infants exposed to other anticonvulsant drugs during pregnancy. More specifically, the prevalence of cleft lip and cleft palate among infants exposed to Topamax in utero was 1.4%, compared to that among infants exposed to other anticonvulsant drugs, which was 0.38-0.55%, and that among infants whose mothers didn’t receive any anticonvulsant treatment while pregnant, which was 0.07% (Source:

FDA Topamax Q&A 

The FDA’s Topamax question and answer document provides concerned women with information regarding the birth defects potentially associated with Topamax use during pregnancy. According to the FDA, women of childbearing age who are currently taking Topamax should consult their healthcare provider to discuss alternative treatment options. Because cleft lip and cleft palate are birth defects which occur during the first trimester of pregnancy, it is possible for women of childbearing age taking Topamax to expose their unborn child to the drug before they are even aware they are pregnant. The FDA does stress, however, that it may be dangerous to suddenly discontinue the use of Topamax, and that Topamax users should seek medical guidance before making any decisions to stop taking the drug.

The FDA advises pregnant women who are currently taking Topamax to contact their healthcare provider to discuss the risks and benefits of continuing Topamax treatment during pregnancy. The agency also encourages pregnant women taking Topamax to discuss with their healthcare provider the possibility of registering with the NAAED Pregnancy Registry, which collects information about outcomes in infants born to women treated with anticonvulsant drugs during pregnancy, in order to more adequately inform consumers.

Topamax Possibly Linked to Cleft Lip and Cleft Palate Birth Injuries

Cleft lip and cleft palate are congenital malformations, which means they are present at birth, and there is no possibility of these defects occurring after a child is born, even if the child was exposed to Topamax in utero. However, women taking Topamax who are breastfeeding their child should be aware that topiramate does pass into breast milk, and the effects of exposing infants to topiramate through breast milk are still unknown.

Topamax was originally classified as a pregnancy category C drug when the drug was first approved by the FDA, which means there was data from animal studies suggesting potential fetal risks, but no adequate data from human studies were available at the time of approval. Now that the FDA is aware of the potentially harmful nature of Topamax use during pregnancy, all Topamax labels are being updated to include the new information regarding the increased risk of cleft lip and cleft palate.

Although the FDA has received reports of cleft lip and cleft palate disorders in the agency’s Adverse Event Reporting System, which collects reports from consumers, physicians, pharmacists, and drug manufacturers, this data from the NAAED Pregnancy Registry was more helpful in determining a link between Topamax use and oral clefts, according to the FDA.

FDA Advisory Regarding Topamax Use During Pregnancy

The FDA has advised physicians to avoid prescribing Topamax to pregnant women unless the possible benefits of the drug justify the potential risks to the fetus (Source: Women taking Topamax who are currently pregnant or planning to become pregnant should consult their physician in order to find a safer alternative to Topamax for treating their medical condition. For more information regarding the birth defects potentially associated with the anticonvulsant drug, Topamax, visit the Topamax page on the Consumer Justice Foundation website.

Posted Under: FDA - Food and Drug Administration
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