Study Reveals Use of Active Ingredient in Topamax During Pregnancy Increases Risk of Oral Birth Defects

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A recent study performed and published by researchers from Harvard University, MassGeneral Hospital for Children and Loyola University in Chicago, entitled Comparative Safety of Topiramate During Pregnancy, revealed in its conclusion that women who ingest topiramate, the active ingredient in a medication known as Topamax, increased the risk that their children would be born with major oral birth defects. The Consumer Justice Foundation is continuing with its effort to bring this critical information to the public along with providing informational resources such as that allow parents to remain up-to-date on the risks that could be encountered while they are expecting a child.

The Consumer Justice Foundation, an entity that works to provide updated information regarding potential health risks and other problems that could be encountered by consumers specifically as they relate to insurance companies and large pharmaceutical corporations, hereby announces that a study has been released that describes the potential risks faced by pregnant mothers who use medications such as Topamax during their first trimester of a pregnancy.

The study, entitled Comparative Safety of Topiramate During Pregnancy was performed by researchers at MassGeneral Hospital for Children, Harvard University and the Loyola University in Chicago. The work centered on a statistical analysis of 6,456 pregnant women who had enrolled in the North American AED (antiepileptic drug) Pregnancy Registry. The study compared the frequency of adverse pregnancy outcomes for those who had used topiramate during their first trimester to a control group.

The results showed that children whose mothers used topiramate during the first trimester of pregnancy were almost three times as likely to be born with a major malformation as compared to children whose mothers did not ingest this substance. Specifically, the percentages were 3.8 percent compared to 1.3 percent, respectively.

This is not the first issue regarding the potential for Topamax birth defects to arise. The FDA has warned consumers about the dangers of the drug, stating in a Safety Alert issued in March, “Before starting topiramate, pregnant women and women of childbearing potential should discuss other treatment options with their health care professional. Women taking topiramate should tell their health care professional immediately if they are planning to or become pregnant.”

About the Consumer Justice Foundation

The Consumer Justice Foundation, whose Web site can be found at, is a for-profit organization that serves two purposes for consumers: (1) to provide educational information regarding the policies and procedures of large corporations and how they affect the average consumer; and (2) to provide news updates and resources that continue to update consumers regarding developments taken by corporations that include pharmaceutical drug companies, auto manufacturers and insurance companies. The team at the Consumer Justice Foundation is staffed by experienced and passionate consumer advocates whose mission is to raise the awareness of issues that could pose a risk of harm to those who may not otherwise be aware of the dangers they face.


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Faith Anderson
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