Consumer Advocacy Group Petitions for Blindness Warning on Viagra, Levitra, and Cialis

The well-known consumer advocacy group Public Citizen is asking the FDA to add black-box warnings to the labels of Viagra, Levitra, and Cialis. The drugs, used to treat impotence, have been linked to an increase in incidences of blindness among patients.  

The petition calls for the FDA to add the highest level of drug warning to the labels of Viagra, Cialis, and Levitra as well as Revatio, a drug used to treat hypertension.

A small number of patients taking prescription drugs to treat impotence have developed non-arteritic ischemic optic neuropathy (NAION), a disease that causes a loss of vision that typically cannot be restored.  NAION is one of the most common causes of abrupt vision loss in older individuals.  

People with diabetes and heart disease are specifically at risk for developing NAION.  Incidentally, these two risk factors are also two of the leading causes of impotence.

In July, two less severe warnings were added to the labels of Viagra, Cialis, and Levitra regarding sudden vision loss but the FDA said that it could not yet be determined if the drugs were the reason for the reported cases of NAION.  

At that time, the FDA advised patients to stop taking the pills and to notify their physician immediately if they experienced a sudden or decreased loss of vision in one or both eyes.  

In order to further examine this risk, however, Public Citizen looked at FDA data and compared the rates of individuals who were taking impotence drugs and those taking Lipitor, a cholesterol lowering drug that is used by people with similar risk factors.  

The findings indicated that the number of reports of NAION per million prescriptions was 18 times higher for Viagra patients and 25 times higher for Cialis patients compared to individuals taking Lipitor.  

Pubic Citizen has argued that this indicates a higher risk of blindness for patients taking impotency drugs than previously acknowledged by the FDA.

Between 1998 and 2004 the FDA reported 48 cases of NAION in individuals taking Viagra.  Other visual problems were reported by an additional 50 people.

Yet out of some 89 million prescriptions that were issued during that time period, only a handful of people actually experienced this adverse risk.

Dr. Sidney Wolfe, the director of Public Citizen’s Health Research Group argues that the FDA must take responsibility to immediately inform consumers about the risk relating to impotence drugs.  The only acceptable solution, he says, is for a black-box warning to be issued. 

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