F.D.A. Asks Pfizer to Add Viagra Warning on Vision Loss

NY Times ^ | May 27, 2005 | JENNIFER BAYOT

[neverdem]

The Food and Drug Administration said today that it had asked Pfizer Inc., the world's largest drug maker, to amend its warnings on Viagra in response to scattered reports of vision loss by people taking the drug.

Some blindness was reported by 38 men taking Viagra - a tiny fraction of the 23 million people who have used the drug - and among four men taking Cialis, a newer competitor.

None of the 100 or so clinical trials on Viagra have suggested that the drug causes vision loss, but the F.D.A. said it had suggested updating the drug's warning label as a precaution. The makers of Cialis, Eli Lilly & Company and the Icos Corporation, have already added such a warning.

Suzanne Trevino, a spokeswoman for the F.D.A., said that some of the patients who reported blindness might have been predisposed to it. "We're not able to specifically say that these 38 cases are a result of the patients' taking Viagra," she said.

Nevertheless, she added, "we are taking this seriously and are working with the company to make sure that doctors and patients are aware of it."

It is unclear whether men who take impotence drugs are any more likely than other men to develop the type of blindness reported, a disorder known as non-arteritic anterior ischemic optic neuropathy. NAION is common among people over 50 who have conditions like diabetes, heart disease, high blood pressure and high cholesterol - factors that also contribute to erectile dysfunction.

Pfizer said in a statement that dozens of clinical trials, involving 13,000 patients, had found no reports of such vision loss from taking Viagra, which has been on the market since 1998. "There is no evidence showing that NAION occurred more frequently in men taking Viagra than men of similar age and...

[Publius6961]

I wish they would cut that out.
Mother nature has a way of weeding out the undesireables.
And I don't mean the ones who genuinely need it for medical purposes.

[Rakkasan1]

Mr.Magoo meets Woody Woodpecker

[Yossarian]

Let's see, roughly 1.5 in a million odds, and it isn't clear if the drug had anything to do with it.....

.....and so the FDA is going to open the floodgates of ambulance-chasing lawyers on to Pfizer, making the drug more expensive, if not unavailable.

This after what - 4.5 years of complete Republican control? It's enough to make a grown man cry!

[Moonman62]

I assume the warning will be not to use it solo.

[bannie]

HA! It WILL make you go blind!

[WestVirginiaRebel]

I thought it was "Natural stimulation" that was supposed to make you go blind...

[bayourod]

Exactly what my mother warned me about. The warning on the bottle should state that before before taking, one should ask his wife or girlfriend, "Is you is or is you ain't."

[DB]

Actually I suspect adding that to the warning label reduces their liability not increase it.

[GRRRRR]

dp;di doie,ps
dleio eoi paoc,e a;appp!~

d

[OldEagle]

My guess is that it will sell a bunch os eyeglasses.

[TYVets]

When you are young it will make you go blind.

When you are old it will make you go blind.

What next ? The AMA will say when you are middle aged it will make you go blind.

[Ole Okie]

I thought it was "Natural stimulation" that was supposed to make you go blind...

Naw, "natural stimulation" grows hair in your palms.

[knarf]

Well, There's this doctor see, that attends the same church as I do, and about 2 years ago the ads offered free Viagra, just ask your doctor ... sooooo I leans offer during the offertory and ... pssst! ... yo, doc?
Ya?
Can y' get me some of that Viagra?
Sure
And sure enough, the next week, in a plain brown paper bag ... I kid you not ... a plain brown paper wrapper was three free samples of Viagra.

Well .... that night ..... heh, heh, heh ... me n' the kids' mother ... um ... fooled around.

Pretty good stuff.
Uneccesary (for me, at 57 (^8/ ... ) but ... um ... fun!

Now, I'm not the brightest bulb on the tree, but I figured if one dose was so good ... what would two do?

Not much more in the 'fun' department, but I had BLUE vision. It was like weaqring those different colored sunglasses.

I asked my doc the next week about that and all he said was, "That sometimes happens".

Never took the stuff again.

[knarf]

OOPS ... leans offer should be leans OVER.
No man LEANS offer .... (^8/

[Don Carlos]

I assume the warning will be not to use it solo.

There ya go. Cause and effect!

[org.whodat]

Really wanted to read this, can someone tell me how too make the letter's bigger???

[SandyB]

I would think that many more than 38 would go blind out of any group of 21 million old men, for any reason.

[ErnBatavia]

[neverdem]

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