Potentially Dangerous Diet Drug Approved - Consumer Justice Foundation

Potentially Dangerous Diet Drug Approved

Written by Faith Anderson on July 18, 2012
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Concerns Over Potential Qsymia Side Effects

An FDA advisory panel voted 20-2 to approve Qsymia back in February, which was the first time the agency voted to approve a diet drug in more than ten years. Although Vivus initially submitted the weight-loss medication as Qnexa, the FDA required the drug maker to change the name in order to prevent potential confusion with other similar-sounding medications. Data presented to the FDA by Vivus indicated that the drug helped patients lose approximately 10% of their body weight.

Although some have touted the agency’s recommendation for Qsymia’s approval as a much-needed alternative to diet, exercise and bariatric surgery for obesity, serious concerns have been raised about possible side effects and the potential for the diet drug’s mass marketing to perpetuate the “magic bullet approach to weight loss, which is limiting and does not address the root problem,” says Dr. Gerard Mullin, an associate professor at Johns Hopkins School of Medicine. A shocking one-third of Americans are obese, and many struggle with chronic medical problems as a result of their condition, including diabetes, heart disease and arthritis. Qsymia is a combination of two FDA-approved drugs: phentermine, a stimulant that triggers amphetamines to suppress the appetite, and topiramate, an epilepsy drug used to treat migraines and seizures that has weight-loss benefits.

Qsymia Uses Topiramate, Seizure Drug Possibly Linked to Birth Defects

One of the primary concerns about the safety of Qsymia is related to its use of topiramate. Most well-known by brand name Topamax, topiramate is commonly prescribed to patients suffering from seizures associated with epilepsy and as a preventative measure for chronic migraine headaches. Topiramate first became available in the United States in 1996, and has since been widely used by physicians across the country. Unfortunately, recent studies have outlined the potential side effects of topiramate, which may include serious birth defects in babies whose mothers take the medication during pregnancy. In light of the risk of potential topiramate birth defects, the FDA has labeled the anticonvulsant drug a pregnancy category D medication, which means there is positive human evidence of the drug’s potential to interrupt fetal development and cause malformations.

When Vivus first submitted Qsymia for approval in 2010, the FDA voted it down due to concerns over the potential for serious birth defects, heart problems and cognitive effects like lack of concentration and mental fogginess in patients taking the medication. The recent FDA panel voted to approve Qsymia only with Vivus’ assurances that the firm would provide physicians with detailed information about the side effect risks associated with the medication, and how to manage them. Still, healthcare providers are mixed in their support of Qsymia, especially in light of the dubious history of diet drugs like fen-phen – a weight-loss medication approved by the FDA, and then withdrawn from the market over concerns about heart side effects and other dangerous health risks. “Honestly, I won’t be surprised if adverse effects over time result in a reversal of [Qsymia’s] approval,” said Dr. David Katz, director of the Yale Prevention Research Center. “But in the interim, it will help some people lose weight, and many others will try it, dislike it and stop, gaining the weight back.”

Posted Under: FDA - Food and Drug Administration
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