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Qsymia Webpage’s ‘3 Times Faster’ Weight-Loss Claims Draw US FDA Ire

 
• By Sue Sutter

Claims that Vivus' obesity drug helps patients lose weight faster than diet and exercise alone are false and misleading because the clinical studies were not designed to evaluate the rate of weight loss over time, Office of Prescription Drug Promotion says in untitled letter; Vivus says it is finalizing revisions to its promotions.

obesity
US FDA says Vivus' claims about the rate of weight loss with Qsymia don't measure up. • Source: Shutterstock

The US Food and Drug Administration has taken Vivus Inc. to task for Qsymia promotional claims about the rate of weight loss with the obesity drug based on studies that assessed the amount of weight loss.

Claims on a Qsymia (phentermine/topiramate extended-release) product webpage that assert the drug helps patients lose weight “3 times faster” than diet and exercise alone are false and misleading because the referenced clinical studies were not designed to evaluate the rate of weight loss over time, the Office of Prescription Drug Promotion said in a 22 May “untitled”

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