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

To: Anthony Wong who wrote (3006)	5/28/1998 7:59:00 PM
From: Anthony Wong	Respond to of 9523

Pfizer Statement on Reports of Six Deaths for Viagra Patients; No Change in Viagra Product Label Thursday May 28, 7:10 pm Eastern Time 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. Viagra was extensively tested in more than 21 clinical trials that assessed safety and efficacy in men with ED. ED is associated with medical conditions that include high blood pressure, heart disease, diabetes, depression and spinal cord injury. Pfizer has reiterated 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. As stated in Viagra's label, sexual intercourse, like other forms of physical exertion, increases the heart rate as well as the cardiac work load, and physicians may wish to assess their patients' cardiovascular status prior to initiating any treatment for ED. Pfizer again stated that patients taking nitrates in any form, including nitroglycerin and long-acting nitrates commonly used for chest pain, should not take Viagra. In addition, patients taking Viagra should not be administered nitrates. Large and sudden drops in blood pressure can occur with the co-administration of these two drugs. ''Viagra is an important therapeutic advance in the treatment of a medical condition that affects 30 million American men and their partners,'' said Joseph Feczko, M.D., senior vice president of Medical and Regulatory Operations for Pfizer Pharmaceuticals Group. ''Used appropriately, Viagra meets a major medical need that can profoundly affect the quality of life for couples.'' Pfizer Inc. is a research-based health care company with global operations. Pfizer reported revenues of $12.5 billion in 1997 and will invest approximately $2 billion in R&D in 1998. SOURCE: Pfizer Inc. biz.yahoo.com