FDA: DEATHS OF 16 VIAGRA USERS AREN'T EVIDENCE OF NEW DANGERS

WASHINGTON -- Deaths among men who took the wildly popular impotence pill
Viagra have climbed to 16, including seven men who reportedly died during
or after sex, a reminder that sexual exertion in older men can be risky
with or without a pill.

The fatalities ranged from the oldest man, an 80-year-old who collapsed
suddenly in the middle of having sex, to the youngest, a 48-year-old, who
experienced chest pains while having sex and later died in a hospital
emergency room.

The Food and Drug Administration, aware of growing public attention to
reports of men dying after using Viagra, released details on the 16 cases
Tuesday but said there is no known direct link between the drug and the
deaths. Most of the men who died had had underlying disease, including
heart disease, high blood pressure or diabetes, the FDA said.

Many of the deaths were attributed to heart disease, although some of the
men were taking -- or had been prescribed -- other medications known to be
dangerous when taken with Viagra.

The FDA said the deaths do not represent newly identified dangers related
to the drug.

``We continue to believe the drug is safe, and people should talk to their
health care providers about using it,'' said agency official Lorrie McHugh.
``We expect we will continue to get ongoing reports and we will monitor
them.''

At least 1.7 million prescriptions have been written for Viagra, sold by
prescription and made by New York-based Pfizer Pharmaceuticals, since it
received FDA approval in March. The drug works by relaxing muscles and
allowing increased blood flow to certain areas of the penis, leading to an
erection.

But Viagra can have life-threatening interactions with other drugs,
specifically heart medications containing nitrates, such as nitroglycerin.
Nine men died during the clinical trials of the drug.

Physicians and others have repeatedly pointed out that many of the men
seeking Viagra are middle-aged or older, whose impotence is often the
result of ailments such as heart disease and diabetes. Some doctors have
complained that men seeking Viagra have failed to disclose that they are
taking other medications.

More details of the deaths among Viagra users are listed on the FDA
Internet site: http://www.fda.gov

Checked-by: (Joel W. Johnson)