SAN FRANCISCO (MarketWatch) -- Bayer Pharmaceuticals and GlaxoSmithKline have been ordered by federal regulators to pull a television ad for their impotence drug, Levitra, because it made an unsubstantiated claim and failed to include information about side effects.
The Food and Drug Administration on Friday sent a letter to a Bayer BAY, official outlining what elements it believes were missing or exaggerated in the advertisement. The letter was also posted on the FDA's Web site.
GlaxoSmithKline GSK, +0.12% , with Schering-Plough SGP, , markets Levitra for Bayer.
The FDA said the "My Man" ad fails to address Levitra's side effects, including a warning that taking alpha-blockers in addition to Levitra can produce hypotension.
"The TV ad fails to include the specific indication for the drug (namely, treatment of erectile dysfunction) or the required risk information," the FDA wrote to Bayer. "The TV ad also fails to make adequate provision for dissemination of the FDA-approved labeling."
Company officials at Bayer could not be reached for comment Saturday. A call to GlaxoSmithKline wasn't immediately returned.
Also in the ad, a woman asks, "In the mood for something different? How about Levitra," followed by a statement that doctors should be asked "if Levitra is right for you. It's the best way to experience that difference."
The FDA says those lines suggest the drug is superior to other treatments for erectile dysfunction and that it's not aware that Levitra provides better results than other drugs.
The agency said Bayer should submit data, if any, to substantiate the claim.
Shares of Bayer fell 75 cents to $32.96 on Friday. Shares of GlaxoSmithKline rose 32 cents to close at $47.82. Schering-Plough shares rose 8 cents to end at $20.65.
Levitra "reminder" ads pulled from TV


The Food and Drug Administration (FDA) has penned a stiff reminder to drug giants Bayer Pharmaceuticals Corp. and GlaxoSmithKline PLC: pull your 15-second “reminder” ad for the erectile dysfunction drug, Levitra, off TV.

FDA said there is no evidence Levitra is better than rival drugs Viagra from Pfizer, or Cialis, owned by Eli Lilly and Co., in producing results that make female partners happy.

Levitra and Cialis together control about 30 per cent of the market for such drugs, but Pfizer takes the majority share.

Reminder ads can only call attention to a drug, not claim it works better, or at all.

"In one of the ad's scenes, the man strokes the woman's hair and face as she affectionately puts her hand on his wrist," the FDA wrote. "In the other, she puts her arms around his neck and they embrace."
 
"The totality of the TV ad also represents or suggests that Levitra will provide a satisfying sexual experience from the female partner's perspective," the agency wrote.

Glaxo spokesman Michael Fleming said the drug makers would comply. Bayer developed Levitra and partnered with Glaxo to market the pills in 2001. Bayer recently turned its part of the promotion over to Schering-Plough Corp.

Shares of Bayer fell 75 cents to $32.96 on Friday. Shares of GlaxoSmithKline rose 32 cents to close at $47.82. Schering-Plough shares rose 8 cents to end at $20.65.