Qsymia Webpage’s ‘3 Times Faster’ Weight-Loss Claims Draw US FDA Ire
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.
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Kowa Pharmaceuticals' patient testimonials implying switch from statins to Livalo will reduce drug side effects are misleading, untitled letter says.
‘Untitled’ letter is FDA's third in the past eighteen months to target promotions for women’s health products. In the case of advertisement for CooperSurgical's copper-containing intrauterine device, which is regulated as a drug, the agency took issue with distracting visuals and reliance on superimposed text.
Agency says superimposed text about risks and efficacy is overshadowed by "attention-grabbing before-and-after photographs" of patients treated with the seborrheic keratoses treatment.