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Serious warning labels sought for 3 ED drugs

October 22, 2005

A consumer group is asking the government to add the most serious of warnings to the labels of Viagra and other impotence drugs, noting some users have gone blind.

Public Citizen, the consumer group petitioned the Food and Drug Administration on Thursday to add black-box warnings to the labels of Viagra, Cialis and Levitra, as well as the hypertension drug Revatio, which is similar to Viagra.

A small number of people taking the impotence drugs have developed NAION, or non-arteritic ischemic optic neuropathy, a loss of vision that is frequently irreversible. The condition is considered one of the most common causes of sudden vision loss in older people, with anywhere from 1,000 to 6,000 cases a year. Risk factors include diabetes and heart disease, which are also two of the leading causes of impotence.

In July, the FDA ordered less prominent warnings to be added to the labels of the three impotence drugs. The warnings noted that some users had suffered vision loss but cautioned that it was impossible to know if the pills were to blame.

To read more, visit… http://www.philly.com/mld/inquirer/living/health/12967296.htm

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