FDA POSTS WEB SITE ON VIAGRA DEATHS -- UP TO 16, BUT CAUSE
UNCLEAR

Bowing to a public fascination with all things Viagra, the Food and
Drug Administration has begun posting on the Internet regular updates
of deaths among patients who had taken the popular anti-impotence pill.

Sixteen deaths have now been reported to the FDA among men who have
taken the drug since it hit the market in April. The first six deaths
were reported May 21.

``We'll monitor these reports to see if they lead us to any trends,''
said FDA spokeswoman Lorrie McHugh.

Of the sixteen deaths, seven occurred among men who were having sex or
shortly after they had sex -- raising some concern that patients too
ill for the exertion of sexual activity were being tempted to try it
by the promise of the drug.

But now, as was the case in May, it is uncertain whether the
medication played any role in the deaths of the men who took it.
Scientifically, the anecdotes are almost meaningless. Three of the
cases were merely accounts of deaths reported in the media.

Both the FDA and Viagra's maker, Pfizer Inc., continue to voice their
confidence in the pill.

``It's a new drug. We're not going to pretend we're not going to see
things we didn't find in the trials. But in terms of overall safety,
we are reassured,'' said Pfizer spokesman Andrew McCormick.

Since its approval as the first effective pill to treat impotence,
more than 1.7 million prescriptions for Viagra have been filled,
making Viagra the most popular new drug ever sold.

Pfizer estimates that 85 percent of Viagra users are over age 50, many
of them with physical conditions such as high blood pressure or
diabetes that can cause impotence.

Of the 16 reported deaths, 10 were in men older than 60. The youngest
man to die was a 48-year-old with a history of diabetes who had chest
pains during sex and was given nitroglycerin by ambulance crews.
Nitroglycerin, like Viagra, dilates blood vessels, and in combination
can lead to a dangerous drop in blood pressure. Nitrate drugs are the
one class of medications that Viagra's label warns against mixing.

Nitroglycerin is routinely administered to patients suspected of
having a heart attack, and anecdotal accounts like this one led Pfizer
to warn emergency room personnel and paramedics to ask victims if they
have taken Viagra.

ON THE NET

The FDA is posting its Viagra case report updates at
http://www.fda.gov/cder/news/viagrapostmarket.htm

1998 San Francisco Chronicle - Page A7

Checked-by: (trikydik)