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

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To: E'Lane who wrote (7891)5/6/1998 10:28:00 PM
From: EyeDrMike  Read Replies (2) of 23519
 
Viagra's bad side may top forecasts

Problems with the anti-impotence drug are exceeding expectations. Misuse may be the cause.
By Marie McCullough and Michael Vitez
INQUIRER STAFF WRITERS

The latest on Viagra may leave a lot of men feeling blue.

The new anti-impotence drug that's flying off the shelves is causing some users to see blue. And to
have blurred vision and sensitivity to light.

And to have headaches, flushing and upset stomachs.

Worst of all, for an estimated 30 percent of users, Viagra is causing nothing.

"When the pill came out, I was elated," said Frank J. Mitros, 69, of Audubon, Pa. "I thought I
could throw away the needles. This would be so easy, like taking an aspirin. I'm bitterly
disappointed."

Those side effects of Viagra, made by Pfizer Inc., were predicted, but may be a bigger problem
than anticipated because of misuse. Viagra was approved only for men who are diagnosed as
impotent, but men seeking to boost their performance are also rushing to try it. Some are also
experimenting with high doses.
The potential for abuse, and uncertainties about long-term side effects, prompted the American
Academy of Ophthalmology to warn men yesterday to watch out for visual disturbances, especially
if they have eye problems such as macular degeneration or retinitis pigmentosa.

Drug labeling

Pfizer's studies found that, at recommended doses -- a pill of 25 mg to 100 mg once a day --
visual changes were mild, lasted only a few hours, and occurred in 3 percent to 11 percent of
users. The drug labeling advises patients with retinitis pigmentosa to use Viagra "with caution."

But eye doctors are already hearing that the bluish tinge to vision may be happening more
frequently at prescribed doses, and they're worried about patients taking higher doses, said
Academy spokesman Michael F. Marmor, a Stanford University ophthalmologist.

"This is the sort of drug [ where ] men tend to think: 'If one pill is good, then let's see what I can do
with four,' " Marmor said.

He conducted a study that showed a 200-mg dose of Viagra reduced retinal function by 30
percent to 50 percent for at least five hours.

Another concern, Marmor said, is whether the drug may cause cumulative or permanent changes in
vision. "We need to do some studies about the long-term effects of taking Viagra," he said.

The U.S. Food and Drug Administration has not required Pfizer to conduct any further studies, but
Viagra's warning labeling could be revised if new information about adverse effects becomes
available, FDA spokeswoman Susan Cruzan said.

Upset stomachs

At doses up to 100 mg, Viagra's most common side effects were minor in studies: Seven percent
got upset stomachs, 10 percent had flushing, and 7 percent got headaches. One area urologist said
yesterday he hasn't received enough feedback yet to draw conclusions.

"I've heard from a handful," said Leigh Bergmann, attending urologist with Bryn Mawr Hospital.
"Three said they were doing better, and two asked if they could increase the dose beyond FDA
recommendations." James Barada, an Albany, N.Y., urologist and spokesman for the American
Urological Association, said: "One patient left me a note. It says: 'It works. Gleefully, Jack.' The
other guy gives me his sample of Viagra back and says it gave him the worst headache, that
brought him to his knees, and didn't help him . . . . Are we meeting expectations? To some we are,
and to some we aren't."

Mitros is in the latter camp.

He tried twice last week. Both nights, he resorted to a second pill. All he got was an upset
stomach.

"My lady fiend and I went to her apartment, played some music, and got into the usual procedures
and all," Mitros said. "And she said to me: 'I don't see anything happening.' And I said: 'I don't feel
anything happening.' I was not going to waste the evening. One didn't work. Maybe I better try
two. Twelve o'clock came, and nothing happened." Same thing the next night.

"I spent $275," he lamented. "With all the advertisement, all the publicity, I thought: 'Gee, what a
wonderful thing.' I was willing to spend $275 for 30 pills. I thought it would be worth it."
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