FDA: 16 MEN REPORTED TO HAVE DIED ON VIAGRA

WASHINGTON (Reuters) - The U.S. Food and Drug Administration (FDA) described
Tuesday the cases of 16 men reported to have died after taking the
blockbuster impotence drug Viagra.

The oldest was 80, the youngest 48, and seven of them died just after having
sex, according to the brief FDA descriptions.

The FDA stressed that there was no evidence the drug, sold by Pfizer, caused
the 16 deaths -- and some of the reports of deaths were unconfirmed. But
Viagra, known generically as sildenafil, is known to have dangerous
interactions with some other drugs.

Pfizer says 1.7 million prescriptions have been written for the drug since
it hit the market in April. The drug works to get more blood to the penis
during sexual arousal, allowing a man to have an erection.

Doctors point out that most of the men taking Viagra are middle-aged or
older, and that impotence is a symptom of underlying disease such as heart
disease or diabetes.

But reports earlier this month that six men had died after taking the drug
sent Pfizer's stocks down sharply. The stock again fell Tuesday just after
the FDA published its descriptions, but recovered, gaining four points to
112, when it became clear the agency was not sure whether the drug caused
any of the deaths.

``As of June 8, 1998, the FDA has received 16 unduplicated reports for
Viagra in which there was a fatal outcome,'' the FDA said in a statement
posted on its Internet web page at www.fda.gov.

``In some of these cases, the reported clinical data was incomplete, and
there is no way to determine that these drugs caused the reported
reactions,'' the statement added. ''Furthermore, a given reaction may
actually have been due to an underlying disease process or to another
coincidental factor.'' The FDA and Pfizer have said they consider Viagra to
be a safe and effective drug.

The statement, released as the result of a Freedom of Information request,
briefly describes each of the 16 cases. Three were based on media reports
and another one appeared to also be a secondhand report.

Viagra is known to interact with certain heart medications, notably those
containing nitrates, and doctors have been warned not to prescribe the drug
to such men. But three of the cases seem to have involved just such
interactions.

Some doctors have complained that men have lied to them about what drugs
they are taking. The drug is also available through the Internet -- a
Reuters reporter obtained the drug via a Canadian site.

Many of the 16 cases described involved older men who were taking heart
medications. The men whose deaths were listed all died of heart attacks or
heart disease.

Case number one involved a 63-year-old man who had a history of diabetes,
high blood pressure, high blood cholesterol and irregular heart beat.

``Approximately one hour after taking medication and engaging in sexual
activity, patient had a hemorrhagic stroke,'' the FDA said. ``Patient's
condition deteriorated in the hospital, and he expired. Cause of death was
not listed.''

Another man, aged 62, died of a heart attack, congestive heart failure and
high blood pressure half an hour to an hour after taking Viagra. He had not
had sex, according to the FDA.

The 80-year-old man, who collapsed suddenly during sexual activity, was
taking Hytrin, known generically as terazosin, for an enlarged prostate
gland. The drug can lower blood pressure. The man also had a history of
irregular heart beat.

A 48-year-old victim had chest pains during sex and was given nitroglycerin
in the ambulance -- something the FDA and Pfizer have warned against. ``He
died in the emergency room,'' the FDA said.

In May Pfizer wrote a letter to doctors, emergency room workers and other
health professionals warning them not to give nitroglycerin to men who had
recently taken Viagra.

Checked-by: Melodi Cornett