The FDA ordered Bayer and GlaxoSmithKline to pull a TV ad for impotence drug 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 that 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." 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. The Post reminds readers that 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.
The AP reports that Pfizer was also ordered last week to stop distributing 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. The ads suggest that the healthy individual has taken Zyrtec and that the other has taken a different allergy medication. AP reports that 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. This is the fourth warning that Pfizer has received from FDA about Zyrtec ads.