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Topic: Viagra Users Report Blindness (Read 334 times)

Rhune
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Viagra Users Report Blindness
« on: May 28^th, 2005, 3:19pm »

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By Lisa Richwine
Fri May 27, 2:24 PM ET

WASHINGTON (Reuters) - U.S. health regulators said on Friday they have received more than 40 reports of a type of blindness in men taking impotence drugs, mostly involving Pfizer Inc.'s Viagra, but have not determined if the medicines were responsible.

The U.S. Food and Drug Administration said it has received about 38 reports of the rare condition among Viagra users, four reports among users of Eli Lilly and Co.'s Cialis and one report in a man who took Levitra, made by GlaxoSmithKline Plc .

More than 23 million men worldwide have taken Viagra over the past seven years, Pfizer said. Reports are extremely rare of the condition known as non-arteritic anterior ischemic optic neuropathy (NAION), the company said. NAION can cause permanent vision loss.

" FDA is aware of these reports but has not determined there is a cause and effect due to use of Viagra ... We're working with the company to make sure this information is available to doctors and patients," FDA spokeswoman Susan Cruzan told Reuters.

New York-based Pfizer said it is weighing a change to the Viagra label. But it emphasized no proof exists that the blindness is linked to the drug, which was introduced in 1998 and had $1.68 billion in sales in 2004.

"While we expect the FDA to take these cases seriously, we do not believe they warrant concern with the product at this time," AG Edwards & Sons analyst Al Rauch said in a research note.

The news pushed shares of Pfizer, a component of the Dow Jones industrial average, down more than 2 percent, weighing on the broader market.

NO EVIDENCE OF LINK

Viagra's label currently lists the most common side effects as headache, facial flushing and upset stomach, and says less common events are bluish or blurred visions and sensitivity to light that may occur for a short time.

"There is no evidence showing that NAION occurred more frequently in men taking Viagra than men of similar age and health who did not take Viagra," Pfizer said in a statement.

Dr. Michael Berelowitz, Pfizer's vice president for worldwide medical, said in an interview he did not think the FDA would require a "black box" warning - the strongest for prescription drugs - about the NAION reports.

Pfizer contacted the FDA about the blindness cases in March, after a study in the Journal of Neuro-Ophthalmology reported seven cases of NAION in Viagra users, Berelowitz said. The study said the cases occurred within 36 hours after the men took Viagra.

All of the patients had high blood pressure, diabetes or elevated cholesterol - conditions that raise the risk of NAION, the study said. All of the men had some degree of blurred vision or vision loss in one eye. Only one developed the problem in both eyes.

"It's quite hard to see causality" between the vision loss and Viagra use, Pfizer's Berelowitz said.

The FDA said patients should contact a doctor if they have questions about the drugs or the condition.

Eli Lilly spokeswoman Kindra Strupp said the company changed its label on Cialis earlier this week to note the reports of NAION. Five million men have taken the drug, she said.

Officials at GlaxoSmithKline could not immediately be reached for comment. The FDA will talk with GlaxoSmithKline about the Levitra label, Cruzan said.

FDA critic Sidney Wolfe said the agency should mandate a black-box warning for all three impotence pills, even though the blindness problem appears rare.

"The trade-off between blindness and something that could remedied by some psychological counseling is a really bad trade-off," said Wolfe, director of Public Citizen's Health Research Group.

Pfizer shares fell 64 cents, or 2.2 percent, to $28.28 in afternoon trading. Shares of Eli Lilly were unchanged. GlaxoSmithKline shares gained 34 cents, or 0.7 percent, to $49.74. All three companies were trading on the New York Stock Exchange.

(additional reporting by Kim Dixon in Chicago)

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Superchic7777
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Re: Viagra Users Report Blindness
« Reply #1 on: May 28^th, 2005, 5:25pm »

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Hey, isn't Viagra some kind of birth control pill for men? Trust me, I wouldn't know.

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Congratulations to Kelly and Alec, winners of Dancing With The Stars!

yesteach
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Re: Viagra Users Report Blindness
« Reply #2 on: May 28^th, 2005, 5:32pm »

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on May 28^th, 2005, 5:25pm, Superchic7777 wrote:

Hey, isn't Viagra some kind of birth control pill for men? Trust me, I wouldn't know.

Thank you! I'm sure you have no idea why - but, thanks anyway... Grin

On the other hand, so many amusing yet inappropriate comments running through my mind about this... so many children here keeping me from posting them... Lips Sealed

« Last Edit: May 28^th, 2005, 5:34pm by yesteach »

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There are only 10 types of people in the world... those who understand binary, and those who don't.

Isle_be_back
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Re: Viagra Users Report Blindness
« Reply #3 on: May 29^th, 2005, 4:49am »

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Look at it this way...At least they won't need a cane. Grin

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lakelady
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Re: Viagra Users Report Blindness
« Reply #4 on: May 29^th, 2005, 10:49am »

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^^^

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luci
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Re: Viagra Users Report Blindness
« Reply #5 on: May 29^th, 2005, 1:17pm »

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We all have found something amusing to say about this recent
study!
As Mr L said, he can't think of a better way to loose his eyesight. Shocked

.......ooops, modified to add the rest of what he said,
"if and when he ever needs it!"
Whew, that gets me off the hook if he comes by and reads this post. Wink

« Last Edit: May 29^th, 2005, 1:39pm by luci »

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"A friend is someone who knows the song in your heart and
can sing it back to you when you have forgotten the words."

lakelady
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Re: Viagra Users Report Blindness
« Reply #6 on: May 29^th, 2005, 1:27pm »

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Good one Mr. L!

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luci
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Re: Viagra Users Report Blindness
« Reply #7 on: May 29^th, 2005, 1:34pm »

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That's my guy Grin

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"A friend is someone who knows the song in your heart and
can sing it back to you when you have forgotten the words."

rcs_mum
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Re: Viagra Users Report Blindness
« Reply #8 on: May 29^th, 2005, 1:37pm »

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I always thought one didn't need Viagra-or a partner to go blind. Lips Sealed

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luci
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Re: Viagra Users Report Blindness
« Reply #9 on: May 29^th, 2005, 1:41pm »

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that's what I've always heard also Lips Sealed

One day I'll tell ya'll the story of us on our honeymoon and the two whales that "didn't move" in the ocean for three days! We still get a chuckle from this one! Grin

Maybe in the Lacy Ladies Lounge Wink

« Last Edit: May 29^th, 2005, 5:26pm by luci »

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"A friend is someone who knows the song in your heart and
can sing it back to you when you have forgotten the words."