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

To: BigKNY3 who wrote (5236)	8/27/1998 12:07:00 AM
From: Anthony Wong	Read Replies (1) \| Respond to of 9523

This Reuters "deaths" report adds details on statistical significance of data 08/26 13:27 FDA says 69 deaths among U.S. Viagra patients (Adds details on statistical significance of data) By Jonathan Wright WASHINGTON, Aug 26 (Reuters) - At least 69 Americans who took the erection-enhancing drug Viagra died in the first four months it was on the market, the Food and Drug Administration (FDA) said in a new report. But the deaths, which have been mounting steadily over the months, may not indicate any special danger from the Pfizer Inc.<PFE.N> drug, given the age, health and large number of men who are taking it, specialists said. Doctors have written out 3.6 million prescriptions and millions of men have taken the drug, which was hailed on its release in March as the long-awaited wonder drug for many men who had difficulty getting an erection. "If there is a one in 100,000 chance of something happening that's pretty low ... What I tell my patients is that there is uncertainty. I think it's a safe drug but I think long-term studies are going to tell us how this works out," James Barada, a urologist in Albany, New York, told Reuters on Wednesday. The FDA, collating voluntary accounts from many sources, said 18 of the patients died during or immediately after sexual intercourse. Within a further five hours of taking the drug, seven others had begun to show whatever symptoms eventually led to death, said the the report that was posted on Monday on the agency's Internet site. Dr. David Flockhart, an expert in drug interactions at Georgetown University in Washington, said in a recent interview that it would be very hard to blame such deaths on Viagra. "I wonder what the baseline death rate is without Viagra," he said. "How many people die during the act anyway?" "If you age-index it for how many medical problems the individuals have and you take out those who took it inappropriately, I don't know of any huge disasters," William Steers of the University of Virginia said of earlier figures. The FDA noted that the link with Viagra was circumstantial and it did not know how comprehensive its data was. "An accumulation of adverse event reports does not necessarily indicate that the adverse event was caused by the drug. The event may be due to an underlying disease or some other factor or factors," the report said. "As with all approved medications, the FDA will continue to monitor the ... safety of Viagra by carefully reviewing reports of death and other serious adverse events and will continue to evaluate the need for regulatory action," it added. The FDA received reports of 123 patients dying after being prescribed Viagra, including 12 foreigners. In the case of 30, the reports were from unverifiable sources and another 12 people may not have taken the drug, despite having the prescription. Of the remaining 69 U.S. patients -- 66 identified as men and three of unidentified gender -- two had strokes and 46 had cardiovascular events. The cause of death was unknown or not mentioned in the other 21 cases. Reports to the FDA gave ages for 55 of the dead. They ranged from 29 to 87, with a median of 64, it said. Fifty-one of the 69 patients had one or more of the factors associated with cardiovascular diseases or cerebrovascular disease, such as hypertension, smoking or obesity. Twelve of the men who died had taken nitroglycerin or a nitrate medication, which can be fatal if taken in conjunction with Viagra. Viagra acts by enhancing the muscle relaxant effects of nitric oxide, a chemical that is normally released in response to sexual stimulation. This allows increased blood flow into certain areas of the penis, leading to an erection. The labeling warns patients not to mix it with nitrate-based heart drugs and advises a thorough medical examination before the drug is prescribed. "There is a degree of cardiac risk associated with sexual activity; therefore, physicians may wish to consider the cardiovascular status of their patients prior to initiating any treatments for erectile dysfunction," the labeling adds. But one consumer group, Public Citizen, said last week that the labeling was not strong enough. "The FDA, in their rush to approve this drug, never put this drug before an advisory committee," said Dr. Sidney Wolfe, director of Public Citizen's health research group. "There are a number of studies in different species showing damaged blood vessels with long-term use. This is not terribly surprising but there is no mention in the labeling," he added. The American College of Cardiology and the American Heart Association have expressed concern about the use of Viagra by patients with any kind of heart disease. Barada, who helped draw up erectile dysfunction guidelines for the American Urological Association, said he was concerned about the deaths because some people may have a special sensitivity to the drug and some doctors might be prescribing it to the wrong people. "There may be a population that is more sensitive to these drugs than we were able to pick up in the trials. It may be playing Russian roulette with a little blue pill," he said. moneynet.com@NEWS-P1&Index=0&HeadlineURL=../News/NewsHeadlines.asp&DISABLE_FORM=