Pubdate: Fri, 22 May 1998
Source: San Francisco Chronicle (CA) 
Contact:  
Website: http://www.sfgate.com/chronicle/ 
Author: Sabin Russell, Chronicle Staff

DEATHS OF SIX VIAGRA USERS REPORTED BY DRUGMAKER

Six patients who had taken the wildly popular impotence pill Viagra have
died since the drug hit the market last month, the Food and Drug
Administration confirmed yesterday.

It remains uncertain, however, whether the medication played a role in the
deaths or if it was coincidental that victims had taken the pill. The fear
is that a combination of Viagra and the heart medication nitroglycerin, used
routinely to treat chest pain, can lead to a fatal drop in blood pressure.
It was a drug interaction that Viagra maker Pfizer Inc. had warned of, but
that patients might not have taken seriously in the giddy popular embrace of
the new treatment. ``I knew this was coming,'' said Dr. Myron Murdock,
director of the Impotence Institute of America, an organization of impotence
patients and their doctors, located in Bowie, Maryland.

Murdock said he hoped that the deaths -- if confirmed to be related to
Viagra -- will not lead the FDA to pull the drug from the market, because it
has proven itself so effective for its intended use. His clinic was involved
in the initial testing of Viagra, and it currently writes 50 prescriptions a
day for it.

Nationwide, an astonishing 570,000 prescriptions for Viagra were filled in
the month of April, turning the impotence pill into an instant pop culture
phenomenon, the object of intense curiosity as well as the subject of
potential abuse.

``The public has to realize that this is a serious drug,'' said Murdock.

FDA spokeswoman Lorrie McHugh told the Associated Press that the agency will
look into death reports to determine if added warnings are needed.

The reports are so recent that the FDA has not had time to determine whether
or not the deaths are related to Viagra use. Pfizer is required to report
any adverse affects to the FDA, whether or not they are thought to be
related to the medication.

The FDA has warned about Viagra's potential heart-medication interactions
since the drug's approval on March 27, and for now, the ``FDA continues to
believe the drug is safe and effective'' when used in the appropriate
patients, McHugh said.

Pfizer spokesman Brian McGlynn said yesterday that the company ``reports all
adverse events to the FDA on a timely basis.''

He observed that, during the clinical trial of the drug among 4,000 men,
there were eight deaths, none of which were attributable to the drug.

In the wake of the latest reports, however, ambulance crews and emergency
room doctors throughout the nation began revising their procedures. San
Francisco paramedics and city Emergency Department staffers will now ask
patients with heart pain -- both male and female -- if they have taken the
impotence pill within the past 24 hours.

In a press statement issued earlier in the day, Pfizer cautioned that the
drug has not been approved for women, and that clinical trials for women
have not yielded conclusive results.

``We routinely ask patients what medications they are on, but Viagra is a
medication that patients might not be forthcoming in telling a stranger they
are on it,'' said Dr. Marshal Isaacs, Emergency Medical Services director
for the San Francisco Fire Department.

Isaacs noted that nitroglycerine is routinely administered to patients
complaining of chest pain, who may be suffering from angina or a heart
attack. The drug dilates blood vessels, lowering blood pressure and easing
the workload of the heart.

The problem with Viagra is that it, too, dilates blood vessels, although the
activity is restricted primarily to the pelvic region. The drug was
originally tested as a medication to lower blood pressure, but it didn't
work for that.

©1998 San Francisco Chronicle Page A18

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Checked-by: Melodi Cornett