This article appeared in the NY Times :
By THE ASSOCIATED PRESS
BETHESDA, Md., April 10 -- A tablet called Uprima may
soon be cutting into Viagra's impotence-drug market
after
government advisers recommended today that the tablet
be
approved for sale to the public despite some worrisome side
effects.
One in 30 men who tested the optimal dose of Uprima fainted or
suffered
seriously low blood pressure; a few fell and hit their heads,
and one
crashed his car into a fence, the Food and Drug Administration
said.
"There will be some people who will probably lose their lives
because
they pass out at the top of stairs or are operating a car"
when they faint,
warned Dr. Peter Kowey, one of the agency's scientific
advisers.
Still, because Uprima did help some men regain erections
strong enough
for sexual intercourse -- and because many of the nation's
estimated 30
million impotent men are not helped by other medications --
the panel
voted 9 to 3 today to recommend that Uprima could be sold as
long as
men and their doctors receive strong warnings.
The F.D.A. is not bound by the decisions of its advisers but
typically
follows them.
Uprima's manufacturer, TAP Pharmaceuticals, said men
desperately
needed alternative treatments.
But Mariann Caprino, a spokeswoman for Pfizer, the maker of
Viagra,
said that Viagra remained safer and more effective than
Uprima.
Viagra became a huge seller when it went on the market in 1998
as the
only oral impotence treatment. But Viagra has killed some men.
Viagra's
big risk is a deadly interaction when taken by men using
nitrate-containing
heart medicine.
TAP said that in studies of 3,000 patients, most lasting a
month, no one
died or had heart attacks. Still, the F.D.A.'s advisers could
not say
whether Uprima would be any safer for nitrate-using heart
patients.
But Uprima does work very differently than Viagra. Viagra
increases
blood flow in the penis. Uprima works in the brain.
"Your brain is your most important sexual organ," said Dr.
Timothy
Fagan of the University of Arizona, who helped test the drug
for TAP, a
joint venture between Abbott Laboratories and Takeda
Pharmaceuticals.
Uprima is not an aphrodisiac, Dr. Fagan said. It seems to
increase
dopamine -- a neurochemical that sends messages between cells
-- in a
region of the brain thought important for causing erections.
Also unlike Viagra, Uprima is not swallowed. The tablet is
dissolved
under the tongue, where it seeps into the bloodstream.
In studies, men who took 2 milligrams of Uprima had an
erection that
enabled intercourse about 47 percent of the time. Success
increased to
56 percent when men took 4 milligrams of Uprima.
But a sugar pill worked for these same men a third of the
time, the
F.D.A. cautioned.
Doses of Uprima higher than 4 milligrams were a little more
effective, but
caused so many more side effects that TAP decided not to sell
the higher
doses.
But even the optimal 4-milligram dose caused either low blood
pressure
or a brief fainting spell in one of every 30 men, agency
officials said.
In addition, about 5 percent of men suffered nausea, vomiting,
dizziness,
sweating or sleepiness.
Uprima is a new formulation of a chemical called apomorphine
once
used, at higher doses, to induce vomiting.
--
Cheers ,
Joao Paulo - Salvador,BA,Brazil
