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 Health & Beauty | October 2005 
Top-Level Warning Sought for Viagra
 Newsday
A consumer advocacy group is calling for the government to add the most serious of warnings to the labels of Viagra and other impotence drugs, noting that some users have gone blind.
Public Citizen petitioned the Food and Drug Administration yesterday 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 frequently is irreversible.
NAION 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 leading causes of impotence.
In July, the FDA ordered less prominent warnings be added to the labels of the three impotence drugs. The warnings noted that some users have suffered vision loss, but cautioned it was impossible to know if the pills are to blame.
Public Citizen, however, used FDA data to compare the rates of people who developed NAION while on the impotence drugs with those who were taking Lipitor, the cholesterol drug that is used by people with the same risk factors.
The group found that the number of reports of the condition per million prescriptions was 18 times higher for patients taking Viagra and 25 times higher for Cialis compared to Lipitor. The group contends this more closely associates the risk of blindness with the impotence drugs.
The actual number of cases is few: Between 1998 and 2004, there were 48 reports to the FDA's database of people taking Viagra and developing the condition. Public Citizen found an additional 50 cases of other visual problems among Viagra patients, the group said in its petition. That's out of 89 million prescriptions written during that period.
Vision problems reported among those taking Cialis and Levitra number 12, including two NAION cases, both in Cialis users, Public Citizen said.
"It is the Food and Drug Administration's job to immediately and coherently tell consumers about the risks associated with the drugs they put into their bodies," Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said in a statement. "The agency has once again failed in this responsibility." |
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