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

FDA opposed to Friday ordered pharmaceutical company Bayer and
GlaxoSmithKline to discontinue a tv poster all for the erectile
dysfunction medication Levitra
because the agency say the hoarding make unconfirmed claim merely
about the good point of the nursing and do not amply enumerate
latent line-up effects, the... Washington Post reports. In the
15-second ad, titled "My Man," an actress ask, "Who's inside the
subject matter for something dissimilar?" She add that Levitra be
"the most favourable principle to suffer that unlikeness."
According to FDA, the ad suggest that Levitra is more influential
than other medication in the treatment of erectile dysfunction.
FDA "is not mindful of great testimony or substantial clinical
experience that Levitra is top-quality to other (erectile
dysfunction) treatment," according to an agency release. GSK
herald Michael Fleming said that the companies will comply next
to the FDA direct. He added that the 15-second ad is considered a
"reminder ad" and does not consist of the list of side effects
that the 45-second book does. However, FDA allowed said that
reminder ad cannot include hearsay on the effectiveness of
medications or how to outgoings them. FDA said, "The totality of
the TV ad also represent or suggests that Levitra will distribute
a big sexual experience from the womanly partner's perspective,"
and the companies cannot prove that declare. FDA eventual
November ordered Pfizer to discontinue ads for the erectile
dysfunction medication Viagra because the
ads slipshod to share a confidence the clause that the medication
treat and list potential side effects (Ahrens, Washington Post,
4/16).

FDA Orders Pfizer To Discontinue Direct-Mail Ads for Zyrtec In
related word, FDA on Friday ordered Pfizer to discontinue
broadcasting of three direct-mail ads for the allergy medication
Zyrtec because the ads create unproven claims about the
effectiveness of the treatment. In the ads, an "obviously woozy
person" is go around with to an personal who "looks impeccably
thriving," according to AP/Long Island Newsday. The ads advise
that the healthy individual enjoy taken Zyrtec and that the other
has taken a different allergy medication. In a message to Pfizer,
FDA officials said that they be "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 grades the
fourth admonition that Pfizer has received from FDA about Zyrtec
ads. FDA said that Pfizer must include in a renowned reply to the
agency an summation of devices to make "truthful, nonmisleading
and complete" correction to the ads (Rodriguez, AP/Long Island
Newsday, 4/17).

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