Impotence Drugs Get Black Box Request

October 2005

Viagra and other impotence drugs may cure a man’s sexual problems, but could cost him his vision. This is why Public Citizen, a prominent consumer advocacy group, wants the black-box warning added to impotence drug labels. The black-box label is the most serious warning given to prescription drugs.

A small number of people who take impotence drugs such as Viagra, Cialis, and Levitra, as well as the hypertension drug, Revatio, have developed NAION, a non-arteritic ischemic optic neuropathy. NAION causes loss of vision that is often irreversible. Risk factors include diabetes and heart disease, which are two leading causes of impotence.

Public Citizen used the FDA’s data comparing people with the same risk factors who developed NAION while taking impotence drugs with those who were taking Liptor, a cholesterol drug. Public Citizen found that the number of reports of NAION per million prescriptions was 18 times higher for Viagra users and 25 times higher for Cialis users compared to Lipitor users.

In July, the Food and Drug Administration (FDA) ordered warnings placed on the drugs’ labels noting that some users experienced a loss of vision but couldn’t be sure the pills were to blame.

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