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Viagra label unchanged
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May 29, 1998: 2:36 p.m. ET
Pfizer decides current warning suffices after discussions with the FDA
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NEW YORK (CNNfn) - Pfizer Inc. will make no change to the label on its popular impotence wonder drug Viagra, the company said, after reviewing the recent deaths of six men who were taking the drug and discussing the case with the Food and Drug Administration.
The pharmaceutical giant on Friday attributed the deaths to cardiovascular events associated with sexual activity in older men or a combination of Viagra and nitrates. Those risks, the company said, are already outlined on the current FDA-approved product label.
The company, which discussed the case with the FDA as a matter of routine practice, said it would report any new benefit or risk information related to the use of Viagra if it became available.
The FDA said "[the six deaths] do not seem to represent a trend or a signal or something worrisome to us at this point." But the organization said it will continue to monitor Viagra's use.
Pfizer also reiterated the appropriate use guidelines for Viagra, including the need for a medical examination and discussion with a physician prior to the initiation of any therapy for erectile dysfunction. Patients taking nitrates in any form should not take Viagra, the company said.
The company (PFE) noted that the male mortality rate from cardiovascular diseases is 185 to 275 cases per million on a monthly basis.
More than one million prescriptions for Viagra have been written since the drug's approval in March. More than 80 percent of prescriptions to date have been for men over the age of 50. 
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Pfizer
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