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Biotech / Medical : VVUS: VIVUS INC. (NASDAQ)

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To: DR.TECH who wrote (8036)5/13/1998 12:56:00 AM
From: Milan  Read Replies (1) of 23519
 
Article.Viagra side effects.

News for VVUS

Some Viagra Users Report Troubling Side Effects
May 9 (The Record/KRTBN)--The impotence drug Viagra, apparently on its
way to becoming the best-selling drug in history after four weeks on
the market, has hit a hurdle: Some Viagra users are complaining about
troubling side effects, including abnormal vision, headaches,
indigestion, and nasal congestion.

As these side effects emerge, health-care experts are voicing concern
that many of the hundreds of thousands of men who've bought Viagra are
taking it for the wrong reasons.

Seventy-four-year-old James of Tenafly, one of the estimated 30
million American men who suffer from impotence, quickly switched from
penile injections to Viagra when it became available last month. He
took 100 milligram doses, which worked fine until he arose in the
middle of the night, walked into the bathroom, and turned on the light.

"Everything looked blue and white," said James, who, like all of the
other Viagra users interviewed, refused to have his last name
published. "It was like the color of fireworks on the Fourth of July.
The world seemed brighter and bluer. I became flush. My eyelids turned
yellow."

While many Viagra users say the little blue pills have helped them
achieve erections without complication, the drug does cause side
effects in a small percentage of patients and should not be used
recreationally by men who can have erections on their own, experts say.

"This is a medicine that should be used only by people who who have an
impotency problem," said Dr. Steven A. Katz, chief of urology at
Englewood Hospital And Medical Center, who has written 100 Viagra
prescriptions in the past two weeks.

"At this time, the treatment appears to be safe," he said. "But people
shouldn't used it recreationally. The side effects were already known,
but now that Viagra's used by millions of men, I'm sure we'll find
other side effects. It's important that men take Viagra under the
auspices of a doctor."

A 50-milligram dose of Viagra helped Peter, 55, of Garfield, have
"very strong and satisfying sex," he said. But after trying a
100-milligram dose, Peter woke up in the middle of the night with "a
tremendous feeling of indigestion and a milky medicine taste in my
mouth," he said.

After Peter cut a 100-milligram pill in half, the complications
disappeared.

James, of Tenafly, who was seeing blue after taking Viagra, also cut
his pills in half and hasn't had problems since. "I'm going to monitor
my condition," James said. "Sex is very nice, but I don't want to ruin
my health."

When Viagra was introduced last month, officials at New-York based
Pfizer warned consumers that the pills, which sell for $10 each, could
cause side effects such as headaches, facial flushing, indigestion,
abnormal vision, and nasal congestion. Pfizer also said Viagra should
be used only by people suffering from impotence, not people looking to
otherwise enhance their sex lives.

Doctors say Viagra has attracted patients who don't need it, or those
who are incorrectly taking high doses. "With all the publicity this
drug has had, I'm sure there are people using it who aren't impotent,"
said Katz, of Englewood Hospital.

"Patients are misguided if they feel that Viagra will help them if
they already have normal erections," said Dr. Howard Frey, director of
Urology at The Valley Hospital in Ridgewood.

The American Academy of Opthalmology in San Francisco, the world's
largest organization of eye doctors and surgeons, has warned that high
doses of Viagra could cause people to see "a bluish tinge" lasting for
at least five hours. "It's not known whether or not the drug causes any
permanent changes in vision," the group said in a prepared statement.

So far, most of the patients for whom Frey has written Viagra
prescriptions have been "happy" with the result. Only a few patients
have complained of headaches, flushing, and nasal congestion, he said.

Viagra, which Cowen & Co. of Boston, estimates could have global sales
of $2.5 billion by the year 2001, works by blocking an enzyme in the
body that thwarts erections.

Pfizer developed the drug as a treatment for angina, then discovered
it helped impotent patients have erections. In clinical trials, Viagra
was tested on 3,700 men with a broad range of medical conditions
associated with impotence, including high blood pressure, diabetes,
high cholesterol, and prostate surgery.

In the trials, it helped 70 percent of impotent men achieve erections,
but caused headaches in 16 percent of patients, flushing in 10 percent,
and abnormal vision in 3 percent of cases.

Viagra helped Frank, 64, of North Jersey, who became impotent four
years ago when he began taking high-blood pressure medication. Becoming
impotent "devastated my manhood," said Frank, who has not had any side
effects from the drug. "Viagra helped me maintain strong erections. I
feel like a man again. Psychologically, it's helped me regain something
I lost. Viagra works as advertised."

His only knock on the drug: "It takes away some of the spontanaety
because you have to take it an hour before having sex," said Frank,
whose health insurance company paid $130 of the $150 cost for 15 pills
he recently purchased. "There's a slight feeling of artificiality to
it. I don't like to operate that way."

However, Frank, said he would not overuse the drug. "I'm only going to
use Viagra every second or third time I have sex," Frank said. "I'm not
the kind of person who likes to use pills as a solution to problems. We
don't know what the long term effects of Viagra are."

When the drug became available, Andy, 58, of Bogota, was eager to use
the impotency pills because the injections he had used to stimulate
erections for the past eight years formed painful scars and
hard-to-control erections.

"The injections were painful because I had to go through scar tissue,"
said Andy, who paid an $8 co-payment for 30 pills of Viagra, valued at
$300. "My erections would last for hours. ... Viagra is much more
comfortable because my erections go down after sex."

Ease-of-use and comfort have helped Viagra sprint past rival impotency
products such as Vivus Inc.'s Muse, Pharmacia & Upjohn Inc.'s
Caverject, and Schwarz Pharma AG's Edex. For the week ending April 24,
Viagra had 97 percent of the 213,202 new prescriptions written for
impotency treatments in America, according to IMS America, a
pharmaceutical research group in Plymouth Meeting, Pa.

Before Viagra's launch, Muse controlled 74 percent of the
new-prescription market for impotency treatments, Caverject had 20
percent, and Edex had 4 percent, IMS said. Viagra's dominance has
boosted Pfizer's stock, which closed at 111 1/8 on Friday, a rise of 49
percent this year.

By Rafael Gerena-Morales
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