Dozens blind after Viagra - FDA searches for possible connection

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Dozens blind after Viagra

FDA searches for possible connection

By VIRGINIA ANDERSON

The Atlanta Journal-Constitution

Published on: 05/28/05

The Food and Drug Administration is studying reports of blindness in

43 men who took Viagra and two other highly advertised drugs to treat

sexual impotence.

The federal agency is discussing with the manufacturers of Viagra,

Cialis and Levitra what labeling changes might be required. Pfizer

manufactures Viagra, Eli Lilly & Co. and ICOS Corp. make Cialis, and

Bayer makes Levitra.

Most of the reported cases of blindness occurred within hours after

taking the drugs. The FDA cautioned that it was impossible to know at

this time whether the drugs caused the vision loss or whether the

blindness could be due to other factors, such as diabetes or heart

disease.

The government also noted the number of men who became blind is small

compared to the millions who have taken the popular drugs.

Thirty-eight were taking Viagra, four were using Cialis, and one,

Levitra, the FDA reported.

" It's a very small number, and we have not been able to establish

cause and effect, " said FDA spokeswoman Kruzan. " At this point,

we want people to know so they can make informed decisions and talk

with their doctors. "

The popularity of the impotence drugs have made " ED, " as erectile

dysfunction is referred to in many television commercials, a

recognizable abbreviation.

An instant hit

Shortly after Viagra hit the market in 1998, it became woven into the

American social fabric unlike few other medicinal breakthroughs. It

quickly became not only a godsend for aging men but also fodder for

television sitcoms and stand-up comics, part of the dialogue in

movies and plays, and a heated topic on thousands of Internet sites.

Pfizer hired no less than Bob Dole, a former U.S. senator and

presidential candidate, to promote its " little blue pill. "

Embarrassment over the need to use the pharmaceutical sexual aid

seemed to vanish, and sales soared. Viagra accounted for $1.6 billion

in sales for Pfizer in 2004, a company spokesman said. More than 177

million prescriptions have been written worldwide for it.

Other drug makers followed Pfizer with their own versions, and the

market spread from aging men seeking help in achieving sexual

intimacy to younger men who use it recreationally for a boost in

sexual stamina and, in some cases, out of sheer curiosity.

" I don't know a guy who hasn't used it, " said Derrick , 40, of

Atlanta, as he sat with his wife and sister outside a restaurant

Friday in Virginia-Highland. " I've tried it. "

He said he now will view the drugs a little differently, but doubts

most users will be too worried.

Not a deterrent

Nick Ransom, 34, also of Atlanta, said he had never used Viagra but

the data reported Friday would not deter him should he need it in the

future.

" Given the nature of the product and what it does, you have to

remember that men have risked far more than their eyes, " he said.

Dr. Sternberg, chairman of ophthalmology at the Vanderbilt

University School of Medicine, said the reported blindness is mostly

irreversible.

The vision loss occurs when blood flow to the optic nerve is blocked.

Once the blood flow is blocked, vision cannot be regained in most

cases, Sternberg said. Doctors liken the condition — nonarteritic

anterior ischemic neuropathy — to a stroke in the eye.

Sternberg said that while the vision loss could be attributed to

other factors, the occurrence in 43 men using impotence

drugs " certainly is suspicious and warrants further investigation. "

Watts, a Pfizer spokesman, said: " There is no evidence that

this occurred in men taking Viagra more often than in men of similar

histories. Some of the risk factors for men who have ED are the same

for men who have vision loss. "

On Friday's news, Pfizer took a small hit on the stock market,

closing down by 55 cents at $28.35.

More side effects

All three of the drugs in question already come with strong warnings

for people who are using medicine containing nitrates not to take the

impotence drugs. They also include warnings about temporary vision

changes, including seeing blue, not being able to distinguish between

green and blue, or seeing halos.

Complicating the FDA's investigation is that the affliction to the

optic nerve is one of the most common causes of sudden vision loss.

Doctors advise that men talk to their doctors about any such concerns

until the FDA study is completed.

Kruzan, the FDA spokeswoman, said she did not know when that would be.