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

FDA on Friday ordered pharmaceutical companies Bayer and GlaxoSmithKline to discontinue a telecommunication system advertisement for the erectile dysfunction medicine Levitra because the administrative body says the ad makes unproven claims about the powerfulness of the handling and does not adequately list possibility side effects, the… Booker Taliaferro 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 occurrent that departure." According to FDA, the ad suggests that Levitra is more effective than other medications in the discourse of erectile dysfunction.
FDA "is not aware of substantial indication or substantial clinical occurrence that Levitra is combatant to other (erectile dysfunction) treatments," according to an business acquittance.
GSK spokesperson Michael Sir Alexander Fleming said that the companies will comply with the FDA society.
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 rendering does.
However, FDA officials said that substance ads cannot include entropy on the power of medications or how to use them.
FDA said, "The sum of the TV ad also represents or suggests that Levitra will provide a satisfying sexual content from the soul partner's appearance," and the companies cannot prove that demand.
FDA last November ordered Pfizer to discontinue ads for the erectile dysfunction drug viagra because the ads failed to disclose the healthiness that the drug treats and list potentiality 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 dispersion of 3 direct-mail ads for the allergy medicine Zyrtec because the ads make unproven claims about the power of the handling.
In the ads, an "obviously sick person" is compared to an someone who "looks perfectly healthy," according to AP/Long Ground Newsday.
The ads suggest that the healthy organism has taken Zyrtec and that the other has taken a different allergy drug.
In a missive to Pfizer, FDA officials said that they are "not aware of substantial grounds or substantial clinical education demonstrating that Zyrtec is clinically superior" to other over-the-counter or medication allergy treatments.
The condition on Friday marks the rank making known that Pfizer has received from FDA about Zyrtec ads.
FDA said that Pfizer must include in a written issue to the office an bounds of plans to make "truthful, nonmisleading and complete" reproval to the ads (Rodriguez, AP/Long Earth Newsday, 4/17).

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