TV ad for impotence drug Levitra ordered killed by feds

WASHINGTON – The Food and Drug Administration has ordered drug giants Bayer Pharmaceuticals Corp. and GlaxoSmithKline PLC to immediately pull a television ad for impotence drug Levitra, saying that the commercial does not adequately state the drug’s potential side effects and that it cannot substantiate claims that it is superior to competitors such as Viagra or that it improves female satisfaction during sexual activity.

The 15-second ad, called “My Man,” which includes the tag line, “Levitra: When it counts,” features an actress asking, “In the mood for something different?” She goes on to say Levitra is “the best way to experience that difference.”

The FDA ruled the claim suggests that Levitra is better than its rivals in treating erectile dysfunction.

“FDA is not aware of substantial evidence or substantial clinical experience demonstrating that Levitra is superior to other (erectile dysfunction) treatments,” the FDA said in a release Friday.

Levitra is the second impotence drug to have one of its television ads pulled. In November, the FDA told Pfizer Inc. to discontinue a Viagra ad that referred to the actor as “wild thing,” saying the company did not state that the drug is for men and failed to mention potential side effects. During the commercial, a browbeaten actor grows blue horns the same color as the pill and appears to become more sexually interested in his female partner.

The drugmakers responsible for Levitra will comply with the FDA’s order, said Michael Fleming, Glaxo spokesman. Bayer developed Levitra and joined with Glaxo to market the drug in 2001. In recent months, Bayer turned its half of the Levitra-promotion business over to Schering-Plough Corp.

Sales of Levitra in 2004 totaled $248 million, according to the companies’ annual reports.