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

To: Ibexx who wrote (3392)	6/9/1998 3:49:00 PM
From: Chris M.	Respond to of 9523

FDA-News on CBS: cbs.marketwatch.com Why do they mention 16 deaths? Is this a misprint?

To: Ibexx who wrote (3392)	6/9/1998 8:28:00 PM
From: R. K. (Chip) Constantian Jr.	Read Replies (1) \| Respond to of 9523

16 Deaths Among Viagra Users Tuesday June 9 6:06 PM EDT dailynews.yahoo.com LAURAN NEERGAARD AP Medical Writer WASHINGTON (AP) - Deaths among men who took the wildly popular impotence pill Viagra have climbed to 16, including seven men who reportedly died during or after sex, a reminder that sexual exertion in older men can be risky with or without a pill. The Food and Drug Administration said Tuesday there is no evidence that Viagra itself is dangerous, although the agency did repeat warnings that heart patients who take nitroglycerin should never take the impotence pill because the drug mix can be deadly. Three deaths suggest that mix happened. Doctors say if there is any risk, some men don't care. ''I've had a lot of patients say, 'If I have to go, that's the way I want to go out,''' said Dr. Ira Sharlip of San Francisco, an adviser on impotence to the American Urological Association. ''I've taken prescriptions out of two patients' hands who lied about (using) nitroglycerin'' because they wanted Viagra so badly, said Dr. William Steers, the University of Virginia's urology chairman. ''Men value sexuality over general health. ... They are going to have this regardless of the consequences.'' The FDA repeated that Viagra is safe and effective when used by appropriate patients. But in response to intense public interest, the FDA posted on its Internet site 16 deaths reported among Viagra users. Nine men already had heart disease, including previous heart attacks, atrial fibrillation, cardiomyopathy or high blood pressure. Because the FDA did not receive full medical information, there is no information about the medical history of six others, including four patients discovered through media reports. Ages ranged from 48 to 80; most were in their 60s and 70s. ''There's no direct link (to Viagra), but we are going to continue to monitor these reports'' in case a pattern suggesting a problem appears, said FDA spokeswoman Lorrie McHugh. ''The bottom line is, patients need to talk with their health care provider and read warning labels before taking this.'' The FDA will regularly update the Internet list as it learns of more deaths. That's considered inevitable because so many older men are flocking to the drug, the very population most at cardiac risk. The American Heart Association counts 418,000 new or recurrent heart attacks in men over 65 every year; about 116,000 die of a heart attack. Pfizer has counted 1.7 million new Viagra prescriptions since it was approved in March, 80 percent of them for men over age 50. The FDA and Pfizer have warned since Viagra began selling that men who take nitroglycerine or related nitrate-containing heart drugs should never take Viagra because the mix can cause large drops in blood pressure. Pfizer just mailed 750,000 doctors a reminder warning. But doctors are finding advice for men with heart disease who don't take the risky nitrate drugs a little tougher. ''I'd be very careful about prescribing it for patients with heart disease until I really understand what their level of risk might be,'' said former American Heart Association president Dr. Sidney Smith of the University of North Carolina, Chapel Hill. The FDA's death report, while not a link, ''certainly raises a red flag and makes everyone aware of the need for more information.'' But University of Virginia's Steers said reports of possible Viagra problems have been extraordinarily low considering how many men take it. He considers the Viagra cautions a good reminder for doctors to more closely examine impotent men for heart disease and get them treated. ''It's amazing how many men don't come in for health problems,'' but have appeared at doctors' doors for Viagra, Steers said. ''You need a complete medical history. ... Ask them about chest pain,'' because that symptom is so often treated with nitroglycerin. Sexual intercourse increases the heart rate about as much as suddenly running up two flights of stairs, Smith said. So Sharlip, who has prescribed Viagra almost 700 times, counsels potential Viagra patients over 60 and anyone with heart disease that there is a small risk of heart attack during sex. --- The FDA's Internet address is www.fda.gov.