US regulators said on Friday they have issued warnings about misleading advertisements for Pfizer Inc's allergy drug Zyrtec and Bayer AG's impotence pill Levitra. The Food and Drug Administration sent letters to both companies telling them to immediately stop using the promotional materials. Bayer's "My Man" television ad, featuring a woman talking about the experience of her male partner, suggested Levitra was superior to other impotence treatments "when this has not been demonstrated," the FDA said.
The ad has been running since September 2004 and will be discontinued, said Matthew Scampoli, a spokesman for Schering-Plough Corp, which took over US marketing rights for Levitra from Bayer last year.
"We're currently reviewing all our Levitra material to address the issues raised by the agency. We will take the FDA's guidance into consideration when developing future ads," Scampoli said.
GlaxoSmithKline Plc also helps market Levitra in the United States.
With Zyrtec, the agency objected to three print advertisements depicting allergy sufferers on an airplane or in an office. The promotions gave the impression Zyrtec was more effective than other allergy medicines, but the FDA is not aware of evidence to support that, the agency's letter said.
Pfizer sells Zyrtec in the United States under a license from Belgian drugs and biotech firm UCB.
High-dose ephedra pills still illegal, US FDA says
The ban on sales of weight-loss herb ephedra remains in place for higher doses despite a court ruling that regulators failed to meet the standard for outlawing low doses, the Food and Drug Administration said on Friday.
The FDA outlawed ephedra a year ago after linking the herb to deaths, heart attacks and strokes. Ephedra was promoted for shedding pounds, boosting energy and enhancing athletic performance, and makers insisted it was safe when used as directed.
On Thursday, a court in Utah ruled on a challenge to the ban from Nutraceutical International Corp and said the FDA had failed to show low ephedra doses posed a "significant or unreasonable risk."
The decision prevents the FDA from enforcing its ban against products containing 10 milligrams or less of ephedra, FDA spokeswoman Kimberly Rawlings said.
"FDA interprets this to mean that the order remains in effect as to higher dosages of these products," Rawlings said.
The agency "is considering all of its options with respect to next steps," she added.
The nation-wide ephedra ban that took effect in April 2004 was the first for a dietary supplement and is considered a key test of the FDA's power over the supplement industry.
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