Parker, Waichman, Alonso LLP

Home » Articles

Viagra Ad Prompts FDA Warning

Apr 22, 2008 | Parker Waichman Alonso LLP

A Viagra ad has Pfizer in trouble with federal regulators.  The Viagra ad, which runs online, does not warn of the erectile dysfunction drug's many side effects, prompting the Food & Drug Administration (FDA) to issue Pfizer a warning letter.  For its part, Pfizer insists the omission was nothing more than a technical error on the website where the Viagra ad ran.

Viagra is a PDE5 Inhibitors that relaxes muscles and increases blood flow to certain parts of the body. Viagra, the most well-known of the PDE5 Inhibitors on the market, was approved in 1998 to treat male erectile dysfunction. In October 2007, the Viagra label was modified to include warnings about sudden hearing loss associated with the drug.  The FDA had requested the changes after it had received 29 reports of patients who experienced sudden hearing loss within hours to two days of taking Viagra.

Many men who take Viagra are older, and it is not unusual for this patient population to experience some hearing loss.  But that is almost always a gradual process, and sudden loss of hearing is rare.   According to the FDA, the sudden hearing loss associated with Viagra was often accompanied by tinnitus – ringing in the ears – and dizziness.   All of the reports involved the loss of hearing in one ear, and in a third of the cases the hearing loss was temporary.

The October 2007 label modification marked the second time Viagra users were warned of a serious side effect. In 2005, the Viagra label was changed to include warnings about vision loss associated with the drugs. This sudden vision loss was attributed to NAION (non arteritic ischemic optic neuropathy), a condition where blood flow is blocked to the optic nerve.

Apparently, a Viagra ad run on CNN.com made no mention of these side effects.  In a letter to Pfizer dated April 16, the FDA said "The video raises public health and safety concerns through its complete omission of risk information for Viagra by suggesting that Viagra is safer than has been demonstrated."

Pfizer said that warning information was supposed to appear in print on the screen, but a technical error prevented it from doing so.  CNN.com confirmed that a technical error did occur, and that it was corrected.  To avoid such errors in the future, Pfizer has pulled all 30-second Internet video ads that require safety information to appear separately on the screen rather than within the advertisement.