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Biotech / Medical : VVUS: VIVUS INC. (NASDAQ) -- Ignore unavailable to you. Want to Upgrade?


To: Tim Gardner who wrote (8347)5/22/1998 12:25:00 PM
From: OmertaSoldier  Read Replies (1) | Respond to of 23519
 
This is the news>

Friday May 22, 11:35 am Eastern Time

FDA reports deaths in men taking Viagra

WASHINGTON, May 22 (Reuters) - Six men have died after taking the blockbuster impotence
pill Viagra, but it is not clear whether any of the deaths were caused by the drug, the Food and
Drug Administration said on Friday.

The FDA said it and Pfizer, the makers of the drug, were investigating the causes of the deaths. But
Pfizer pointed out that more than a million men, most of them middle-aged, have taken the drug.

FDA spokeswoman Laurie McHugh said the six deaths had been reported by Pfizer (PFE - news)
as part of routine, required reporting procedures. ''They reported to us that they had learned of six
deaths of people taking Viagra,'' she said.

''We are going to look into these reports as we do all adverse reports,'' she said. ''We continue to
believe that the drug is safe and effective for its indications and the patient population.''

The drug's label clearly states that it should not be taken by men who are also taking nitroglycerin or
other nitrate drugs prescribed for heart disease, and Pfizer has made this clear in its advertising. On
Thursday Pfizer reiterated those warnings.

The FDA and Pfizer both said they did not yet know whether the deaths were a result of a drug
interaction, or were unrelated to the use of Viagra, the first pill to be cleared for use in treating
impotence.