Pfizer's Impotence Pill Viagra to Carry New Warnings, FDA Says
Bloomberg News
November 24, 1998, 4:04 p.m. ET
Pfizer's Impotence Pill Viagra to Carry New Warnings, FDA Says
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 numerous 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'' in men who have taken the drug. These
include heart attacks, sudden cardiac deaths and high blood
pressure.
The labels warn that men who have a history of heart
problems should be careful about resuming sexual activity.
''The labeling notes that it is not possible at present to
determine whether the cardiovascular events are directly related
to Viagra, to sexual activity, to the patient's underlying
disease or to a combination of these factors,'' the FDA said.
The agency added that it ''continues to believe Viagra is
safe and effective if used according to the updated labeling.''
Shares of New York-based Pfizer fell 1 1/8 to 115.
Officials at Pfizer were not immediately available for
comment. In the past, the company has repeatedly said the drug is
safe when used properly.
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.
--Kristin Jensen and Kristin Reed in the Washington newsroom |
