'Wild Thing' TV ads omit information about Viagra's major side effects and contraindications.

The FDA describes the offending TV spot in its letter as follows:

Wild Thing Is Back

The voiceover of the 30-second TV ad states (corresponding visuals in parentheses): “Remember that guy who used to be called ‘Wild Thing?’” (Man watching wife examine highheeled shoe in store)

“The guy who wanted to spend the entire honeymoon indoors?” (Man looking at high-heeled shoe in store)

“Remember the one who couldn’t resist a little mischief?” (Man gazing at black bra, panties, and negligee in store window)

“Yeah, that guy.” (Blue “horns” sprout from behind man’s head) (Trumpet blasts) “He’s back.” (“He’s back.” written across man’s forehead) (Man moves and the horns become the "V" in Viagra)

“Viagra. Not all medications are for everyone.” (Man opening door to lingerie shop)

“Ask your doctor if Viagra is right for you.” (Man taking wife’s hand and leading her into shop)

Not Enough Information

The TV ads fail to inform viewers that Viagra is indicated for the treatment of erectile dysfunction, as required, says the FDA.

Furthermore, the ads omit information about Viagra's major side effects and contraindications. For example, men for whom sexual activity is inadvisable because of an underlying heart problem should not use it.

The FDA also comments on the risk of prolonged erection greater than 4 hours and priapism (painful erections greater than 6 hours in duration), which are infrequent complications associated with Viagra use. If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result, the FDA states in its letter.

The ads fail to mention that Viagra offers no protection against sexually transmitted diseases, and that possible side effects include headache, flushing, dyspepsia, and abnormal vision (defined as “mild and transient, predominantly color tinge to vision, but also increased sensitivity to light or blurred vision”), the FDA points out.

Unsubstantiated Claim

The TV ads suggest that men who use Viagra will attain a previous level of sexual desire and activity, a claim for which the manufacturer has provided no substantiation, the FDA says.

The letter, which was sent by the FDA's Division of Drug Marketing, Advertising, and Communications, requests that Pfizer immediately cease the dissemination of promotional materials for Viagra the same as or similar to the TV ads. The agency also asks that Pfizer provide a written response to the letter, including an explanation of its plan to comply, by November 24, 2004.