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FDA Looking Into Blindness-Viagra Link
AP ^ | 5/27/2005 | LAURAN NEERGAARD

Posted on 05/27/2005 7:38:40 AM PDT by TX Bluebonnet

WASHINGTON - Federal health officials are examining rare reports of blindness among some men using the impotence drugs Viagra and Cialis, a disclosure that comes at a time when the drug industry can ill afford negative publicity about another class of blockbuster medicines.

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The Food and Drug Administration still is investigating, but has no evidence yet that the drug is to blame, said spokeswoman Susan Cruzan.

This type of blindness is called NAION, or non-arteritic anterior ischemic optic neuropathy. It can occur in men who are diabetic or have heart disease, the same conditions that can cause impotence and thus lead to Viagra use.

The FDA has 42 reports of the blindness, 38 among users of Viagra and four among users of Cialis. There were no cases reported among users of Levitra, the third impotence drug.

"We take this seriously," said FDA's Cruzan.

The FDA is in discussions about the reported cases with the manufacturers of the three drugs in case there is a problem with the class of medication and to see if changes need to be made to their labels.

Eli Lilly & Co., which manufactures Cialis, refers to vision problems as an uncommon side effect, including seeing a blue tinge or having difficulty telling the difference between blue and green. "These are not all the side effects of Cialis," it says on its Web site.

Viagra manufacturer Pfizer Inc. also refers on its Web site to some vision issues: "Less common are bluish or blurred vision, or being sensitive to light. These may occur for a short time." That language had been available before the current inquiry.

Pfizer spokesman Daniel Watts confirmed Friday that the drugmaker was in discussions with the FDA about adding a disclosure to Viagra's label to say that in rare cases, men taking Viagra had developed blindness. However, he said there is no proof that Viagra caused the blindness. He said that men who take Viagra often have high blood pressure and high cholesterol, which are also associated with the conditions that can cause blindness.

Levitra is sold in the United States by GlaxoSmithKline PLC and Bayer AG.

Viagra was approved by the government in 1998. It may aid in the treatment of enlarged hearts that can result from high blood pressure, tests on animals indicate.

Levitra was approved in August 2003, and Cialis in November of that year.

There have been no reports connecting Levitra to blindness, said Michael Flemming, a spokesman for GlaxoSmithKline PLC. "We are confident about the safety of our product," said Flemming.

Levitra, Cialis and Viagra all work in the same fashion, but Flemming said that doesn't mean they all have the same side effects. "Every drug is different. Every drug is unique," he said.

Analyst Jason Napodano of Zacks Investment Research Inc. said he doesn't think Viagra sales will stumble because of the new reports because the number of cases is so small. "It is too early to say that Viagra is causing this (the blindness) and look how small the numbers are," he said.

Viagra, approved to treat erectile dysfunction, should not be used by men with heart conditions whose doctors have warned them not to have sex. Also, patients taking drugs that contain nitrates have been warned not to take Viagra because of sudden, unsafe drops in blood pressure.

The drug's label also warns of erections lasting longer than four hours, painful erections lasting longer than six hours, headache, flushed skin and vision problems.

Pfizer Inc. said in its most recent quarterly filing with the Securities and Exchange Commission that sales of the drug rose 5 percent — to $438 million in the first quarter of the year. Pfizer also said at the time that Viagra had a 68 percent worldwide market share.

Viagra sales have been under pressure from new competitors Cialis and Levitra, with revenue sinking 11 percent last year to $1.68 billion from $1.88 billion. Pfizer shares fell in early trading on the New York Stock Exchange.

Doctors and patients have become increasingly wary of the downsides of prescription drugs after Merck & Co. yanked its pain reliever Vioxx from the market last year because of its potentially lethal side effects.

Merck potentially faces thousands of lawsuits over Vioxx and analysts have estimated its liability may reach $18 billion.

Pfizer was asked to remove its pain reliever Bextra from the market because of its side effects and sales of its other arthritis drug Celebrex are falling. Vioxx, Celebrex and Bextra all fall into a category of drugs known as Cox-2 inhibitors.

Industry critics have been demanding that drug companies conduct more post-marketing studies in order to do a better job of discovering side effects once drugs hit the market.

For more than two decades, Americans have mostly pressed for quicker approval of what they hope can be lifesaving drugs for such diseases as AIDS and cancer. But many now are wondering if medicines — a $200 billion industry annually — are coming out too fast and doing too much harm.

Viagra also is at the center of controversy over Medicaid's payment for prescriptions of the drug to convicted sex offenders in New York and other states.


TOPICS: Business/Economy; Culture/Society; Extended News
KEYWORDS: blindness; viagra
I think the jokes can write themselves...
1 posted on 05/27/2005 7:38:40 AM PDT by TX Bluebonnet
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To: TX Bluebonnet

Viagra...blindness...um...no, I'm not going there.


2 posted on 05/27/2005 7:39:37 AM PDT by RockinRight (Conservatism is common sense, liberalism is just senseless.)
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To: RockinRight
When I heard this on Fox this morning, I thought some hacker was feeding them fake news and the next line would read, and hairy palms..
3 posted on 05/27/2005 7:40:23 AM PDT by mnehring (http://www.mlearningworld.com)
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To: TX Bluebonnet

Just wait till they discover it grows hair.


4 posted on 05/27/2005 7:40:41 AM PDT by Dallas59 (" I have a great team that is going to beat George W. Bush" John Kerry -2004)
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To: TX Bluebonnet

Mom told you that playing with it would make you go blind.


5 posted on 05/27/2005 7:41:10 AM PDT by Jersey Republican Biker Chick (People too weak to follow their own dreams, will always find a way to discourage yours.)
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To: RockinRight

If You Don't Stop, You'll Go Blind...cir 1975.


6 posted on 05/27/2005 7:41:33 AM PDT by Deguello
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To: TX Bluebonnet

I remember an old Sam Kinison routine..


7 posted on 05/27/2005 7:41:37 AM PDT by sheik yerbouty
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To: TX Bluebonnet
Here we go.

Tort lawyers, get in warmup position.

Bye-bye, Pfizer.

(steely)

8 posted on 05/27/2005 7:41:54 AM PDT by Steely Tom (Fortunately, the Bill of Rights doesn't include the word 'is'.)
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To: TX Bluebonnet

Kinda like Beer goggles


9 posted on 05/27/2005 7:41:56 AM PDT by Mikey_1962
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To: Dallas59
"Just wait till they discover it grows hair."

Only on your palms.

10 posted on 05/27/2005 7:42:05 AM PDT by Jersey Republican Biker Chick (People too weak to follow their own dreams, will always find a way to discourage yours.)
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To: TX Bluebonnet

Shucks! Didn't our mamas tell us all that boys would go blind having too much fun and that our teeth would fall out if we kissed boys when we were too young. Have there been any reports of women losing their vision with their version of these pills?


11 posted on 05/27/2005 7:43:03 AM PDT by Virginia Queen (Virginia Queen)
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To: TX Bluebonnet

Cheetos can make male "private parts" orange...I don't know that PERSONALLY...but I heard it somewhere.


12 posted on 05/27/2005 7:43:48 AM PDT by sierrahome (Colfax, CA; "A Small Drinking Town With A Rail Road Problem.")
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To: TX Bluebonnet

Confuscious say what make one see thing hard make one hard to see thang.


13 posted on 05/27/2005 7:44:09 AM PDT by DainBramage
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To: TX Bluebonnet

Can I just do it until I need glasses?


14 posted on 05/27/2005 7:44:40 AM PDT by Bon mots
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To: TX Bluebonnet

Just use it 'til you need these...........

15 posted on 05/27/2005 7:46:35 AM PDT by COUNTrecount
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To: TX Bluebonnet

I'm just surprised no one saw that coming.


16 posted on 05/27/2005 7:47:55 AM PDT by theDentist (The Dems are putting all their eggs in one basket-case: Howard "Belltower" Dean.)
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To: theDentist
I'm just surprised no one saw that coming.

They were blind!

17 posted on 05/27/2005 7:50:54 AM PDT by TX Bluebonnet
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To: theDentist

This might qualify as a Friday Silliness thread if it keeps going...


18 posted on 05/27/2005 7:52:53 AM PDT by RockinRight (Conservatism is common sense, liberalism is just senseless.)
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To: TX Bluebonnet
"Can I just do it till I need glasses?!?"

/Robin Williams
19 posted on 05/27/2005 7:58:21 AM PDT by gopheraj
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To: TX Bluebonnet

I'm having a hard time reading this post.


20 posted on 05/27/2005 8:03:30 AM PDT by kempo
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To: kempo

LOL


21 posted on 05/27/2005 8:15:38 AM PDT by cajungirl ({no})
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To: Virginia Queen
Yes, the report says that women who have been studied, showed they were acting emotionally to problems, have compulsions to shop till they drop and go on frequent crying jags, Oh, wait, never mind.
22 posted on 05/27/2005 8:24:49 AM PDT by RetSignman
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To: TX Bluebonnet

Well...if you're gonna play......you're gonna pay.


23 posted on 05/27/2005 8:28:29 AM PDT by Pillows
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To: Bon mots
Can I just do it until I need glasses?

Are you typing with one hand?

24 posted on 05/27/2005 8:30:08 AM PDT by sportutegrl (Huh?)
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To: Virginia Queen

It messes with the chemical reactions that are also involved
in vision. Some patients had complained of a blue-green
color alteration in their vision.

The blindness linked to its use, may be related to other
factors. Such as the type of patient who usesit...I don't
know if the report said "permanent" blindness..One would
have to examine the eyes of the victims to see if they
have the pathological processes going on that normally
would cause blindness in someone with poor circulation,
or diabetes mellitus. Just don't be surprised when it
turns out these "meds" do a bit more than advertised by
the drug companies, the media, and hopeful scientists, and
researchers.

All in all, you know some of the songs they will not use
in their commercial jingles are:

"I can see clearly now"
"I can see for miles, and miles, and miles..."
"Blinded by the light"
"Green Eyed Lady"
"I'm Looking through you"

Bye.


25 posted on 05/27/2005 9:30:26 AM PDT by Getready ((...Fear not ...))
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To: Getready

Oops...I forgot another song:
can't remember the title, but the words went something, like
"...she blinded me with science...."..Thomas Dolby was
the artist.


26 posted on 05/27/2005 9:32:32 AM PDT by Getready ((...Fear not ...))
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To: Deguello

...and his response was, "Well, can I just keep doing it til I need glasses"?


27 posted on 05/27/2005 9:54:35 AM PDT by mlc9852
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To: TX Bluebonnet

Viagra also causes blisters of the palm too


28 posted on 05/27/2005 10:21:47 AM PDT by GianniV
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To: Getready

and
"My Eyes Adored You"
The radio news says these cases have involved "permanent blindness." However, the accuracy of those depends on their sources. I wonder if they have recorded instances of "fainting" at crucial times.


29 posted on 05/27/2005 11:10:09 AM PDT by Virginia Queen (Virginia Queen)
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To: Steely Tom

Warming up E-Trade
How does that old song go
" We like short shorts"


30 posted on 05/27/2005 11:25:39 AM PDT by international american (Tagline now flameproof....purchased from "Conspiracy Guy Custom Taglines"LLC)
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To: Darksheare; Lady Jag; Dead Corpse; King Prout; Monkey Face; NicknamedBob; Conspiracy Guy; ...

You just can't make this up........


31 posted on 05/27/2005 11:31:22 AM PDT by international american (Tagline now flameproof....purchased from "Conspiracy Guy Custom Taglines"LLC)
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