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

To: SHUBLU who wrote (11974)	7/22/1998 9:39:00 PM
From: Zebra 365	Read Replies (2) \| Respond to of 23519

FDA Confirms 39 Viagra Deaths PLEASE READ BOTH OF THESE NEWS RELEASES...... .c The Associated Press WASHINGTON (AP) - The Food and Drug Administration has confirmed 39 deaths among American men using the popular impotence pill Viagra, but says it remains convinced Viagra is safe when used by the proper patients. The FDA updated Viagra information on its Internet site late Tuesday. The agency revealed that it also has received an additional 38 reports of possible deaths among Viagra users, but it has not been able to verify those reports' accuracy. Twenty-four were hearsay or media reports, eight failed to show whether the men actually took Viagra, and six involved foreign patients, the FDA said. Even the 39 verified reports, however, don't prove the drug was to blame, the FDA cautioned. Viagra carries safety warnings. Doctors must not prescribe it to men who take nitroglycerin or other nitrate-containing drugs because the mix can kill. The FDA also warns that the sudden exertion involved in resuming sexual activity may be too risky for men with heart conditions, and urges doctors to assess heart health before prescribing. The FDA's death reports show six Viagra users who died also took nitroglycerin or other nitrates. At least 24 deaths were deemed heart-related. Eighty-five percent involved men who had at least one risk factor for heart disease. Fourteen deaths are known to have occurred within two hours of sexual activity. Viagra has been prescribed some 2.7 million times since hitting the market in April. AP-NY-07-22-98 1441EDT ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ VIVUS Announces MUSE 18-Month Post-Marketing Safety Data; Over 1 Million Prescriptions and 600,000 Patients Treated, Resulting in Only One Death Reported To FDA MOUNTAIN VIEW, Calif.--(BW HealthWire)--July 22, 1998--VIVUS, Inc. (NASDAQ:VVUS) today announced data from an 18-month post-marketing safety review of MUSE(R) (alprostadil). The VIVUS post-marketing surveillance program tracks spontaneous adverse events reported from commercial sales of MUSE. Since FDA approval in November 1996, over 1 million prescriptions for MUSE have been filled, and approximately 600,000 patients have used MUSE. VIVUS is aware of only one death reported to the FDA from the post-marketing experience. The typical patient using MUSE is an older man, and most users have some degree of vascular disease. The extensive experience with MUSE would be expected to be sensitive to detect new and unexpected risks of treatment in these patients. No such risks have been identified. These results are consistent with the conclusion that there is no apparent increase in cardiovascular risk associated with the use of MUSE. MUSE Clinical Trial Data The clinical trials for MUSE suggested a favorable safety profile for the drug in the general population. In prospective, double-blind, placebo-controlled Phase III clinical trials, 1,156 patients with severe, organic erectile dysfunction were randomized to home treatment with either MUSE or placebo for a three-month period. In the 564 men receiving MUSE, five serious cardiovascular adverse events occurred during the three-month double-blind period. Only one of these events was "possibly" related to the use of MUSE. There were 2,875 occurrences of sexual intercourse. In the 592 men receiving placebo, 10 serious cardiovascular adverse events occurred during the three-month double-blind period. There were 500 occurrences of sexual intercourse. There were no deaths in either group. Three patients suffered myocardial infarction (heart attack); all three were in the placebo group, and these events were not related to sexual intercourse. These data are summarized in the following table: -0- T MUSE Phase III Clinical Trials MUSE Placebo Number of Patients 564 592 Deaths 0 0 Serious Cardiac Adverse Events 5 10 Myocardial Infarction 0 3 Occurrences of Sexual Intercourse 2,875 500 Serious Cardiac Adverse Events/1000 Occurrences of Sexual Intercourse 2 20 T -0- These data support the observation that renewed sexual intercourse with the use of MUSE in men with erectile dysfunction is not associated with an increase in serious cardiac adverse events. The relative risk of suffering a serious cardiac adverse event on MUSE versus placebo was 0.52 (95% confidence interval 0.15 to 1.67). A relative risk less than 1.0 suggests less risk in patients using MUSE compared to those using placebo. As with other medical decisions, VIVUS encourages physicians to review each patient's medical history, treat other remediable conditions, and discuss treatment options with the patient before initiating any therapy for erectile dysfunction. The data reflecting the experience with MUSE are supported by published medical literature showing that sexual activity poses little if any additional risk to the patient with cardiovascular disease. A full bibliography is available upon request. Founded in 1991, VIVUS, Inc. is a leader in the development of advanced therapeutic systems for the treatment of erectile dysfunction, commonly referred to as impotence. VIVUS has pioneered a novel therapy for erectile dysfunction known as MUSE(R) (alprostadil). This therapy consists of a proprietary, non-invasive drug delivery system that delivers pharmacological agents via the urethra. Note to Editors: MUSE is a registered trademark of VIVUS, Inc. Additional written materials, recent releases and Company information are available through a variety of sources, including the VIVUS home page (www.vivus.com) and the VIVUS Fax-On-Demand Service (1-888-329-5719). CONTACT: VIVUS Nina W. Ferrari/David Yntema, 650/934-5200 I thought these two articles should be placed side by side, interesting comparison. I guess it is the placebo effect of Viagra that makes it so dangerous. Zebra