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Pfizer continues to stand by Viagra's safety

–June 28, 2005

Last month, the FDA said it had reports of 38 instances of blindness because among users of Pfizer's popular erectile dysfunction drug Viagra. The condition called NAION, or non-arteritic anterior ischemic optic neuropathy, was also reported among users of Viagra's competitors Cialis and Levitra.

After reviewing Viagra's safety reports, Pfizer said the drug does not increase patients' risk of blindness but that the company is still working with federal regulators to update Viagra labeling to reflect the rare reports of vision loss. Pfizer said it is the company's understanding that the FDA has also asked that similar warning labels be included on all oral erectile dysfunction medicine labels.

The FDA concluded that no casual relationship between Viagra and NAION has been established, and Pfizer said its review of all post-marketing ocular event reports has concluded there is no evidence of increased risk of blindness among Viagra patients but its labeling changes are intended to inform physicians and patients of the reports.

Cialis, made by Eli Lilly & Co. and ICOS, and Levitra, marketed by Bayer, GlaxoSmithKline and Schering-Plough, have both been connected to reports of NAION as well. Bayer said it has not yet decided if Levitra labels will be changed, but a spokesman for Germany-based Bayer said the company was working with the FDA to investigate the reports of blindness.

Still, some experts and patients are convinced that there is enough evidence indicating a very serious Viagra and blindness link. Viagra is the subject of an unknown number of lawsuits claiming the drug caused sudden blindness, and a CBS News investigation found more potential Viagra and blindness links.

After analyzing four years of Viagra adverse events reported to the FDA, CBS found there were eye problems in more than 800 patients with more than 140 cases of partial or total blindness. Although these reports can't prove a direct link between the use of the drug and eye problems, the cases are enough evidence to show a pattern, according to some experts.

The difficulty with determining if Viagra is causing the eye problems is that many men taking the drug are already at an increased risk for eye damage because of circulation problems, which is also why they need to take Viagra. Blaming Viagra for the eye problems can just as easily, according to experts, be blamed on the patient's preexisting conditions. Because there doesn't seem to be a clear answer, however, it makes it even more necessary, some safety experts argue, to determine how real the Viagra risk is to the reported eye problems.

There have been reports made involving Viagra patients with no risk factors at all. Five years ago, British doctors published a case saying the potential for blindness should be discussed with all Viagra patients, especially since men using the drug are already at an increased risk. Pfizer would not comment on that Viagra case, and even though the company is changing the labels, some patients claiming their vision loss is the result of the drug believes the label changes are inadequate.

For more information on Viagra and vision loss, please contact us to confer with an attorney.


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