FDA Warns Pfizer, Bayer, GSK About Unsubstantiated Claims in Ads for Zyrtec, Levitra

Main Category: Erectile Dysfunction / Premature Ejaculation
Article Date: 19 Apr 2005 - 10:00 PST

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FDA on Friday ordered pharmaceutical companies Bayer and GlaxoSmithKline to discontinue a television advertisement for the erectile dysfunction medication Levitra because the agency says the ad makes unproven claims about the effectiveness of the treatment and does not adequately list potential side effects, the... Washington Post reports. In the 15-second ad, titled "My Man," an actress asks, "Who's in the mood for something different?" She adds that Levitra is "the best way to experience that difference." According to FDA, the ad suggests that Levitra is more effective than other medications in the treatment of erectile dysfunction. FDA "is not aware of substantial evidence or substantial clinical experience that Levitra is superior to other (erectile dysfunction) treatments," according to an agency release. GSK spokesperson Michael Fleming said that the companies will comply with the FDA order. He added that the 15-second ad is considered a "reminder ad" and does not include the list of side effects that the 45-second version does. However, FDA officials said that reminder ads cannot include information on the effectiveness of medications or how to use them. FDA said, "The totality of the TV ad also represents or suggests that Levitra will provide a satisfying sexual experience from the female partner's perspective," and the companies cannot prove that claim. FDA last November ordered Pfizer to discontinue ads for the erectile dysfunction medication Viagra because the ads failed to disclose the condition that the medication treats and list potential side effects (Ahrens, Washington Post, 4/16).

FDA Orders Pfizer To Discontinue Direct-Mail Ads for Zyrtec
In related news, FDA on Friday ordered Pfizer to discontinue distribution of three direct-mail ads for the allergy medication Zyrtec because the ads make unproven claims about the effectiveness of the treatment. In the ads, an "obviously sick person" is compared to an individual who "looks perfectly healthy," according to AP/Long Island Newsday. The ads suggest that the healthy individual has taken Zyrtec and that the other has taken a different allergy medication. In a letter to Pfizer, FDA officials said that they are "not aware of substantial evidence or substantial clinical experience demonstrating that Zyrtec is clinically superior" to other over-the-counter or prescription allergy treatments. The order on Friday marks the fourth warning that Pfizer has received from FDA about Zyrtec ads. FDA said that Pfizer must include in a written response to the agency an outline of plans to make "truthful, nonmisleading and complete" corrections to the ads (Rodriguez, AP/Long Island Newsday, 4/17).

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