February 11, 2009 7:23 PM
- Text
Viagra Report Spurs Reaction
(CBS)
A consumer group says it will soon ask the FDA to add the strongest warning possible – a black box – to Viagra and other drugs in the same class after reports of blindness among dozens of men who used the impotence drugs, reports CBS News Correspondent Sharyl Attkisson.
In some respects, the writing may have been on the wall. The makers of Cialis, a Viagra rival, have updated their label warning of rare cases of blindness. The makers of Levitra say they're unaware of any issue with that drug.
But consumer advocate Dr. Sidney Wolfe flagged the potential risk of vision loss in all three drugs in his book "Worst Pills Best Pills," and he alerted the FDA seven years ago when sporadic reports first surfaced.
"We will be asking the FDA in the next couple of weeks to put a black box warning on all three of these drugs' labeling," says Wolfe, "and also to require when a patient gets a prescription filled, that they get an informative and accurate information sheet that warns, among other things, about vision loss."
On Thursday, Attkisson was first to report that a small number of men have gone blind after taking Viagra.
"I've pretty much accepted that my eyesight is not going to come back," said Jimmy Grant, who started using Viagra in 1998, when he was 57. "But I've also pretty much accepted that Viagra done it."
Eye specialist Dr. Howard Pomeranz was first to flag the potential problem in 1998.
"I can't tell you how many other people have contacted me thinking that there may have been an association," said Pomeranz, "that they had raised the issue with their physicians and their physicians had said, 'Well, I'm not aware of that.'"
The FDA says no definite link has been proven, but agrees the public needs to be warned promptly. Just how to do that is what they're discussing. Pfizer says there's no evidence of more vision loss in men taking Viagra than similar men who don't.
Attkisson notes that when talking about a lable change, there are a lot of discussions and negotiations between the FDA and the drug company. It's unlikely the product would be removed from the market.
CBS News Correspondent Elizabeth Kaledin explains the vision loss is often called "the stroke of the eye." There is a certain group of the population that is at high risk, and that would be the same group at risk for having a stroke.
In some respects, the writing may have been on the wall. The makers of Cialis, a Viagra rival, have updated their label warning of rare cases of blindness. The makers of Levitra say they're unaware of any issue with that drug.
But consumer advocate Dr. Sidney Wolfe flagged the potential risk of vision loss in all three drugs in his book "Worst Pills Best Pills," and he alerted the FDA seven years ago when sporadic reports first surfaced.
"We will be asking the FDA in the next couple of weeks to put a black box warning on all three of these drugs' labeling," says Wolfe, "and also to require when a patient gets a prescription filled, that they get an informative and accurate information sheet that warns, among other things, about vision loss."
On Thursday, Attkisson was first to report that a small number of men have gone blind after taking Viagra.
"I've pretty much accepted that my eyesight is not going to come back," said Jimmy Grant, who started using Viagra in 1998, when he was 57. "But I've also pretty much accepted that Viagra done it."
Eye specialist Dr. Howard Pomeranz was first to flag the potential problem in 1998.
"I can't tell you how many other people have contacted me thinking that there may have been an association," said Pomeranz, "that they had raised the issue with their physicians and their physicians had said, 'Well, I'm not aware of that.'"
The FDA says no definite link has been proven, but agrees the public needs to be warned promptly. Just how to do that is what they're discussing. Pfizer says there's no evidence of more vision loss in men taking Viagra than similar men who don't.
Attkisson notes that when talking about a lable change, there are a lot of discussions and negotiations between the FDA and the drug company. It's unlikely the product would be removed from the market.
CBS News Correspondent Elizabeth Kaledin explains the vision loss is often called "the stroke of the eye." There is a certain group of the population that is at high risk, and that would be the same group at risk for having a stroke.
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