FDA Orders Pfizer to Pull TV Ads for Viagra

The Food and Drug Administration ordered Pfizer Inc. to yank cheeky television ads that promised better sex for men taking Viagra because the ads failed to disclose known risks associated with the drug, according to a letter released Monday.

“The TV ads omit the indication for the drug (namely, treatment of erectile dysfunction) and fail to provide information relating to the major side effects and contraindications of the drug, as required,” Christine Hemler Smith, a regulatory review officer, informed Pfizer.

“Remember that guy who used to be called ‘Wild Thing?’ ” the ads say. Later, blue horns sprout from the man’s head and then morph into the signature blue V of Viagra.

The ads “claim that Viagra will provide a return to a previous level of sexual desire and activity,” Smith wrote. “FDA is not aware of substantial evidence or substantial clinical experience demonstrating this benefit for patients who take Viagra.”

Pfizer spokesman Daniel Watts said the company was “in the process” of pulling the TV ads. The company also is drafting a formal response.

Viagra is among the company’s bestselling drugs and accounted for $1.87 billion in global sales last year, including $1.1 billion in sales in the U.S.

Viagra has been in a battle with newer competitors such as Cialis, co-marketed by Eli Lilly & Co. and Icos Corp., and Levitra from GlaxoSmithKline and Bayer.