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On May 22, 2019, the Food and Drug Administration (FDA) issued a letter to drugmaker Vivus that cited the company for making false or misleading claims on a promotional consumer-directed webpage for its oral weightloss prescription drug QSYMIA — a combination of the antiseizure drug topiramate and the stimulant drug phentermine.[1] The agency approved Qsymia in 2012 as an adjunct to a reduced-calorie diet and exercise in certain overweight adults and in obese adults.[2] Public Citizen’s...
On May 22, 2019, the Food and Drug Administration (FDA) issued a letter to drugmaker Vivus that cited the company for making false or misleading claims on a promotional consumer-directed webpage for its oral weightloss prescription drug QSYMIA — a combination of the antiseizure drug topiramate and the stimulant drug phentermine.[1] The agency approved Qsymia in 2012 as an adjunct to a reduced-calorie diet and exercise in certain overweight adults and in obese adults.[2] Public Citizen’s Health Research Group has designated this drug as Do Not Use.
The FDA letter listed claims Vivus had made on its Qsymia webpage about the effectiveness and risks of the drug that are inconsistent with the approved drug labeling. First, the webpage failed to explicitly indicate that diet and exercise are necessary for achieving the benefits of Qsymia. Second, the webpage omitted the results for the control (diet-and-exercise-alone) group in the clinical trials of Qsymia, which suggests to readers that the benefits were due to the drug alone. Third, the webpage claimed that Qsymia can help consumers lose weight three times faster than diet and exercise alone. However, clinical trials of Qsymia assessed the amount of weight loss, not the rate of weight loss.
Finally, in contrast to the information on benefits, the webpage failed to prominently present information about the risks of Qsymia. Specifically, the important risk information was buried at the end of the webpage and not easily accessible to consumers. Additionally, the risk information was in paragraph format, in contrast to the largely colorful and bolded benefit information. Notably, Qsymia has serious adverse effects including cleft lip or palate birth defects in the fetuses of pregnant women taking this drug, as well as increased heart rate and suicidal thoughts or actions. It also can cause impaired vision, mood or memory changes, and increased acid in the blood stream.
We continue to recommend against taking Qsymia or any other weight-loss drug. Instead, we recommend combining lifestyle changes involving reduced-calorie diet and exercise with behavior-based weight loss interventions (including self-monitoring and behavior-change techniques, as well as counseling) for effective and safe weight loss.
References
[1] Food and Drug Administration. Letter to Vivus, Inc. Re: NDA 022580 - QSYMIA (phentermine and topiramate extended-release) capsules, for oral use. May 22, 2019. https://www.fda.gov/media/126604/download. Accessed October 28, 2019.
[2] Vivus, Inc. Label: phentermine and topiramate (QSYMIA). March 2018. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022580s016lbl.pdf. Accessed October 28, 2019.
