An update to the Bloomberg report at Post 6339 (with analyst comments):
Pfizer's Impotence Pill Viagra to Carry New
Warnings (Update1)
Bloomberg News
November 24, 1998, 5:31 p.m. ET
Pfizer's Impotence Pill Viagra to Carry New Warnings (Update1)
(Adds FDA and analyst comment, background.)
Washington, Nov. 24 (Bloomberg) -- Pfizer Inc.'s impotence
drug Viagra will carry new warnings to ensure its safe use, the
U.S. Food and Drug Administration said.
The move is just the latest in a series of additions to the
label of the impotence pill, which saw unprecedented demand in
its first three months on the market. As men rushed to pharmacies
to get Viagra, the FDA received reports of misuse and deaths
among people who had taken the drug.
The FDA said the new warnings come in response to reports of
''serious adverse events'' such as heart attacks, sudden cardiac
death and high blood pressure, in men who have taken the drug.
The new label warns that men who have a history of heart problems
should be careful about resuming sexual activity and instructs
doctors to be cautious when prescribing the drug to patients with
underlying health problems.
Shares of New York-based Pfizer fell 2 to 114 1/8.
The new labeling is ''minimally negative'' for Pfizer, said
Neil Sweig, an analyst with Southeast Research Partners. ''This
is really what (the FDA) has been saying for some time.''
As of mid-November, the FDA had received 130 reports of
deaths among U.S. patients who had taken Viagra, said Lisa
Rarick, director of the division that oversees reproductive and
urological products.
No Black Box
The FDA still can't be sure if there's a direct link between
Viagra and the heart problems and deaths reported to the agency,
Rarick said. If such a link were proved, the agency could place
its most dire warning -- a so-called black box -- on the drug's
label, she said.
''If we felt that the link was very clear at some point,
then yes, absolutely, a black box would be more appropriate,''
Rarick said.
''We're confident in continuing to say that this is a safe
and effective drug,'' Rarick said.
Pfizer said updating the labeling is ''a routine process''
for a new drug. The company said it would ''continue educating
health-care professionals'' about the risks of Viagra use by men
who are also taking heart medicines containing nitrates, such as
nitroglycerin prescribed for chest pain.
Sweig said Pfizer shares might fall again tomorrow as
investors cash in on recent gains in the stock. ''It has the
highest price-earnings valuation in the large cap drug stock
group -- there could be a (market) exaggeration of modestly
negative news,'' said Sweig, who has a neutral rating on Pfizer
because it passed his price target.
Problems have occurred only in a ''small fraction'' of the
more than 3 million patients who have taken Viagra, the FDA said,
and Rarick noted that label changes are a normal part of the
marketing of a new drug. In this case, label changes may seem
unusually frequent because of the drug's wide use, she said.
Household Word
Viagra became a household word after Pfizer won approval for
the drug in late March. It had the most successful drug
introduction in the U.S., with second-quarter sales of $411
million as wholesalers stocked up on the drug.
Since then, however, sales have dropped. The drug had third-
quarter sales of $141 million, below the $150 million to $200
million some analysts had expected.
The new labeling will specifically warn doctors about giving
Viagra to patients such as those who have suffered a stroke or
have very low blood pressure or an eye condition known as
retinitis pigmentosa. Those types of patients weren't studied by
Pfizer in its clinical trials for Viagra, the agency said.
The new label also warns about the possibility of a painful,
prolonged erection that can occur rarely in patients taking
Viagra. ''This is a serious condition that requires immediate
medical attention,'' the FDA said.
At least 16 of the 130 U.S. men who have died after taking
Viagra were also taking heart medicines containing nitrates,
Rarick said. Though the FDA has heard anecdotal reports that
women and men who aren't impotent have tried the drug, the FDA
isn't aware of any deaths among those people to date, she said.
--Kristin Jensen and Kristin Reed in the Washington newsroom |
