VIAGRA GETS EXPANDED HEALTH WARNINGS

Caution: FDA considers popular anti-impotence drug safe, but acts in wake of
130 deaths linked to medicine.

WASHINGTON -- The Food and Drug Administration is adding serious new health
warnings to the label on bottles of Viagra, the wildly popular
anti-impotence drug that has been prescribed for 3 million men since it was
approved for general use in April.

In expanded labels, the government warns doctors and patients that men with
heart problems and very high or very low blood pressure should be carefully
examined before getting a prescription for Viagra.

Patients with retinitis pigmentosa, an eye disease, also are at risk. And
the new description warns about the rare occurrence of priapism, a dangerous
condition involving painful, prolonged erections that can last more than
four hours.

The government still considers Viagra safe and effective, the Food and Drug
Administration said Tuesday. But it is sending a letter to doctors as well
as expanding the information printed on the labels by Pfizer, the drug
manufacturer.

The problem is not Viagra itself but the sexual activity it facilitates. Of
the 130 deaths reported to the FDA among men taking the drug, none has been
directly blamed on the drug. Instead, the FDA believes that many of those
who died -- whose average age was 64 -- had serious health problems that
were aggravated by sexual activity, resulting in heart attacks or strokes.

``The people who died had underlying cardiovascular problems,'' said Dr.
Lisa Rarick, director of the FDA division of reproductive and urologic drug
products.

She said the FDA is advising patients with serious heart problems to discuss
with their doctors whether sexual activity would be wise.

Many men with heart disease may be impotent because of their medical
condition. And the FDA is now emphasizing that sex for these patients
``carries a potential cardiac risk.''

If sex itself might be risky because of a patient's health problems, then
impotence treatments such as Viagra should be avoided, the FDA said in its
three-page announcement of the expanded warnings.

Viagra is prescribed for men who are unable to have erections. More than 6
million prescriptions have been written for 3 million men.

Currently, the Viagra label warns that the drug should not be used by people
taking heart medicine containing nitrates. The combination of nitrates and
Viagra can cause a dangerous, sometimes life-threatening drop in blood
pressure.

The new label will advise that Viagra be prescribed with caution in patients
who:

Had a heart attack, stroke, or a ``life-threatening arrhythmia'' (irregular
heartbeat) in the past six months.

Have a ``history of cardiac failure or coronary artery disease causing
unstable angina.''

Had ``significant'' low blood pressure or hypertension (high blood pressure
above 170/110).

Warning label and notifications are added as a drug increases in popularity
and more is learned about reactions. The changes are coming much faster
because of Viagra's explosive popularity. Usually, it would take a new drug
three to five years to reach Viagra's sales level, the FDA said.

One of Viagra's rare side effects, occurring in 3 percent of the men tested,
is visual disturbance. Its use is now suspected as a possible cause of a
plane crash Saturday that killed an actor, William Gardner Knight, who died
when his light plane crashed in Edgewater, Md. The Federal Aviation
Administration said the state medical examiner was asked to determine
whether Knight had been using Viagra.

Checked-by: Rolf Ernst