PUBLIC CITIZEN: ED DRUGS NEED BLACK-BOX WARNING FOR VISION LOSS

Consumer advocacy group Public Citizen is urging the FDA to immediately require black-box warnings on erectile dysfunction drugs to alert consumers that the products may cause irreversible vision loss.

In a recent citizen petition filed with the FDA, Public Citizen noted that Pfizer's Viagra (sildenafil citrate) accounts for more cases — approximately 19 percent — of a type of vision loss called non-arteritic anterior ischemic optic neuropathy (NAION) than any other drug and more than double the percentage of the next-most-often-reported drug. The group derived its figures from an analysis of the FDA's adverse events database. Public Citizen also found that the number of case reports of NAION per million prescriptions was 18 times higher for patients taking Viagra and 25 times higher for Eli Lilly's Cialis (tadalafil) compared to patients taking Lipitor, another drug used by people with similar cardiovascular risk factors.

The FDA announced in July that it had updated the labeling for Viagra, Cialis and GlaxoSmithKline's and Bayer's Levitra (vardenafil HCl) to alert patients to the NAION risks, but Public Citizen said those changes don't go far enough. The July label changes were recommended by the agency after it received 38 reports of sudden blindness among users of Viagra.

"Many case reports document that vision loss has occurred in close association with the use of these erectile dysfunction drugs, and several reports show that the patients with temporary vision loss experienced such loss again upon re-exposure to the drug," Public Citizen said. "Despite this, the current FDA-approved labeling for the drugs states that, 'It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors,' implying that the drugs do not cause blindness."

The group said manufacturers should have to add a black-box warning to the professional package insert for their ED drugs, and disseminate a "Dear Doctor" letter to all U.S. physicians informing them about the signs and symptoms of NAION.

To view the citizen petition, go to http://www.citizen.org/publications/release.cfm?ID=7403.