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Viagra Label May Note Rare Vision Problems

'No Evidence' of More Frequent Occurrence With Viagra, Says Maker
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May 27, 2005 -- Viagra's label may change to reflect rare vision problems reported by a few men who have used the erectile dysfunction drug.

Viagra's maker, Pfizer, issued a statement saying it is "in discussions with the [FDA] to update the Viagra label to reflect these rare ocular occurrences.

"Viagra has a strong safety profile and remains an effective medication that benefits millions of patients," says the statement. Pfizer says a review of 103 clinical trials of Viagra -- including 13,000 patients -- found no reports of the eye problem, which is called nonarteritic anterior ischemic optic neuropathy (NAION).

WebMD reported on the topic in April, when ophthalmologist Howard Pomeranz, MD, PhD, published a report describing 14 cases of NAION in men taking Viagra.

Viagra has been used by 23 million men worldwide, says Pfizer's statement. The pharmaceutical company is a WebMD sponsor.

A call to the FDA for comment was not returned before publication.

 

 

Pfizer: 'No Evidence' of More Frequent Occurrence

"There is no evidence showing that NAION occurred more frequently in men taking Viagra than men of similar age and health who did not take Viagra," says the Pfizer statement, underlining the sentence for emphasis.

Pomeranz's report appeared in the March issue of the Journal of Neuro-Ophthalmology. Pomeranz, an associate professor at the University of Minnesota, told WebMD in April that he had seen most of the men himself.

"The number of cases was very small," he said. None of the men went blind, although their vision loss was permanent and reportedly started within 24-36 hours of taking Viagra.

Pomeranz didn't test Viagra's eye effects. Instead, he described the men's reports of vision loss.

Most Affected Men Had Other Health Problems

The men in Pomeranz's report were 50-69 years old. Almost all had health problems including high blood pressure, diabetes, high cholesterol, and/or a history of smoking. Most also had a rare structural problem in their optic nerve, which is a risk factor for NAION.

NAION is the most common acute disease of the optic nerve in adults over the age of 50. It shares a number of risk factors with erectile dysfunction. These include high cholesterol, high blood pressure, and diabetes.

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