ParaGard TV Spot Misrepresents Contraceptive’s Risks, US FDA 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.
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Promotional campaign for Stendra (avanafil) included "adult sites" as well as the American College of Cardiology's patient-focused magazine; statements that FDA found problematic in the various ads include "get hard and stay hard" and calling the product a "next generation" PDE-5 inhibitor.
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.