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Biotech / Medical : PFE (Pfizer) How high will it go? -- Ignore unavailable to you. Want to Upgrade?

To: Chris M. who wrote (3028)	5/29/1998 8:33:00 AM
From: John F. Dowd	Respond to of 9523

Current quotes (delayed 20 mins) PFE 106 5/8 0 (0.00%) NEW YORK, May 28 /PRNewswire/ -- Pfizer Inc. said today that it had reviewed the deaths of patients who had received Viagra (sildenafil citrate) and that as a matter of routine practice had discussed the cases with the U.S. Food and Drug Administration.Pfizer is making no changes to the Viagra product label. Pfizer believes that the information available in the cases does not suggest any risk to patients which is not already described in the product label or known for the population being treated with Viagra. From available information, it appears that these cases were attributed to either cardiovascular events associated with sexual activity in older men or a combination of Viagra and nitrates, which is contraindicated in the FDA-approved label.FDA reviews similar reports for all approved prescription pharmaceutical products. These reports are carefully reviewed to assure that the labeling for the product adequately expresses both the risks and benefits for the product. As with any new drug, if new benefit or risk information related to the use of Viagra becomes available, it will be communicated to the medical community.In placing the safety of Viagra in perspective, Pfizer noted that statistics from the National Center for Health Statistics show that the underlying rate of death from all causes in men over 45 is almost 1,600 deaths per million per month. The American Heart Association has estimated that the male mortality rate from cardiovascular disease is 185 to 275 cases per million on a monthly basis.More than 1 million prescriptions for Viagra have been written since the drug's approval on March 27 for the treatment of erectile dysfunction. Pfizer said that more than 80 percent of prescriptions to date have been for men over the age of 50 years.Pfizer said the safety and efficacy information reported since approval is consistent with the clinical trial experience that was the basis for FDA approval.