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Viagra® Label Change

A major Viagra® label change was made in July 2005 to reflect numerous reports of serious visual side effects associated with Viagra® use. Earlier in 2005, consumers were first informed that the FDA had received over 40 reports of sudden blindness or vision loss in men taking Viagra®. The type of vision loss suffered by some Viagra® users and described in the Viagra® label change is called NAION or non-arteritic ischemic optic neuropathy. This painless condition causes vision loss due to blocked blood flow to the optic nerve.

The Viagra® label change states that both the FDA and Pfizer (Viagra®'s maker) are still unsure whether or not Viagra® use increases a patient's risk of suffering serious vision problems. The FDA has approved a Viagra® label change and the label changes for two similar erectile dysfunction drugs: Cialis and Levitra. The Viagra® label change states that NAION can also occur in men who do not take Viagra®.

The Viagra® label change states that some men taking Viagra® may be at an increased risk of developing NAION. Men who are over the age of 50 may be at a greater risk of developing serious eye conditions while taking Viagra®. People with a history of heart disease, diabetes, high blood pressure, high cholesterol or certain eye problems, may also be at greater risk, according to the Viagra® label change. Smokers may also be at an increased risk of developing NAION.

While the FDA approved the July 2005 Viagra® label change, Pfizer adamantly denies that Viagra® increases a patient's risk of developing NAION or other vision loss. One Pfizer representative stated, "After more than ten years of rigorous clinical study and worldwide safety monitoring of a medicine used by more than 27 million men, there is no evidence to suggest a link between Viagra® and blindness or other serious ocular events." Of the 103 Viagra® clinical studies involving more than 13,000 men, not a single case of NAION has been reported.

Despite Pfizer's unyielding denial of the risks contained in the Viagra® label change, several medical experts have discovered scientific evidence that Viagra® may cause serious vision problems. Viagra® has long been known to cause visual side effects, such as changes in blue/green perception and light sensitivity. A Stanford medical study has since discovered that for at least five hours after taking Viagra®, electrical measures of retinal function can drop by as much as 50 percent.

Many of the Viagra® blindness cases that prompted the Viagra® label change were suffered by men with no history of vision problems very shortly after taking Viagra®. One lawsuit has already been filed against Pfizer for failing to inform patients of the serious vision risks associated with Viagra®.

If you have questions about what the Viagra® label change means for you or a loved one, you may wish to contact your physician to discuss your concerns in greater detail. If you have been injured by Viagra®, please contact us to confer with a qualified attorney.

More Viagra® Resources

MedLine Plus Drug Information - Guide to prescription and over-the-counter medications provided by the United States Pharmacopeia.

Viagra.com - Official site of Viagra, a product of Pfizer.