FDA Orders Warnings About Sudden Blindness for Erectile Dysfunction Medication Labels

Main Category: Erectile Dysfunction / Premature Ejaculation
Article Date: 12 Jul 2005 - 1:00 PST

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FDA officials on Friday ordered that labels for erectile dysfunction medications must include warnings about a potential link with sudden blindness but said that the agency has not confirmed a causal relationship between the treatments and the condition, the... AP/Boston Herald reports (AP/Boston Herald, 7/8). In a statement, FDA officials said that certain men -- those who are older than age 50, smoke and have high blood pressure, heart disease or high cholesterol -- have a higher risk for nonarteritic anterior ischemic optic neurophathy, which is caused by an interruption of blood flow to the nerve that links the eye to the brain. However, FDA officials said that that they could not "determine whether these oral medicines for erectile dysfunction were the cause of the loss of eyesight or whether the problem is related to other factors such as high blood pressure or diabetes or to a combination of these problems" (Kauffman, Washington Post, 7/9). FDA officials also said that patients who take or plan to take ED medications should inform their physicians if they have experienced severe vision loss (Wall Street Journal, 7/11).

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Joseph Feczko -- chief medical officer for Pfizer, which manufactures the ED medication Viagra -- said, "There is no evidence that Viagra causes blindness or any other serious ocular condition." Sen. Chuck Grassley (R-Iowa), who has said that an FDA safety officer asked the agency to require warnings about a potential link between ED medications and NAION more than 13 months earlier, said, "It shouldn't take bad publicity to get the FDA to act on the advice of its own scientists and do everything it can to inform and protect the public." He added, "Why did it take more than a year in this case? Did the FDA spend time negotiating label changes with the drug industry and, as a result, withhold vital drug-safety information from millions of patients and their doctors?" (Washington Post, 7/9). NPR's "NPR News" on Saturday reported on the FDA order (Silberner, "NPR News," NPR, 7/9).

The complete segment is available online in RealPlayer.

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