Topamax-Containing Obesity Drug Qnexa Backed by FDA Panel For Approval After Rejection by Agency in 2010 Due to Birth Defect Concerns, Consumer Justice Foundation Reports

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The Consumer Justice Foundation, a for-profit corporation that is staffed by professional consumer advocates who provide free online informational resources regarding certain prescription medications at the URL of, hereby alerts the public that a panel of FDA advisers has voted to back the approval of Qnexa, an obesity drug that contains Topamax, despite a rejection of this medication by the FDA in 2010 based on concerns of Topamax-related birth defects. The drug will now move forward in hopes of obtaining an official approval from the FDA.

The Consumer Justice Foundation, which is a for-profit corporation that is staffed by a team of professional consumer advocates whose mission is to provide the public with free online informational resources regarding the dangers of certain prescription medications, hereby alerts the public that an FDA panel of advisers has voted to back Qnexa, an obesity medication, for approval. Qnexa contains Topamax, and concerns regarding Topamax side effects led to a denial of approval of Qnexa by the FDA in 2010.

Specifically, Qnexa is an obesity medication that is comprised of phentermine, which is a substance that appears in medications that are approved for short-term weight loss and topiramate, an anticonvulsant medication known as Topamax that is manufactured by Johnson & Johnson. Qnexa has shown that patients who use it tend to lose 10 percent of their body weight over the first year of use.

However, Qnexa was not approved by the FDA in October of 2010 because of concerns regarding Topamax side effects that include the tendency for pregnant women who ingested topiramate to give birth to children with birth defects that include oral clefts. Qnexa’s manufacturer, Vivus resubmitted Qnexa for consideration by the FDA with additional study information.

This additional information included studies of 3,386 women who used Qnexa despite precautions asking that women in the study use contraception. An FDA expert on birth defects estimated there would be five babies born with a cleft lip defect for every 1,000 women who became pregnant while taking Qnexa. The advisory panel also stated that if Qnexa was approved, the FDA would require Vivus to train prescribers in the pregnancy risks of Qnexa and distribute warning pamphlets to patients regarding Topamax side effects and the possibility of birth defects.

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 so that consumers who have been harmed can use these informational resources to connect to an experienced professional who can help them. 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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