To: chirodoc who wrote (1138 ) 11/24/1998 5:59:00 PM From: Anthony Wong Respond to of 1722
AP: FDA Issues New Viagra Warnings Tuesday November 24 5:44 PM ET By LAURAN NEERGAARD AP Medical Writer WASHINGTON (AP) - The Food and Drug Administration issued new warnings about the popular impotence drug Viagra on Tuesday, saying that doctors should be cautious about prescribing it to whole groups of men, including those who recently had heart attacks or have very high blood pressure. Some 130 Americans who took Viagra have died since the drug hit the market last spring, the majority from heart attacks, the FDA said. There's no proof Viagra caused the deaths, the FDA stressed. Heart disease kills hundreds of Americans daily, and manufacturer Pfizer Inc. (NYSE:PFE - news) estimates that 6 million prescriptions have been filled since April and that 3 million Americans use it. Still, the FDA notified doctors Tuesday that Pfizer was changing the drug's label to add more explicit warnings. ''We want to make sure people are aware there are some men (for whom) it's not advisable,'' said the FDA's Dr. Lisa Rarick. But if used by the right men, she said, ''we still believe it's safe and effective.'' Viagra's label already stressed that anyone who takes itrate-containing medicines, such as the heart drug nitroglycerin, should never take Viagra. The mix can cause a deadly drop in blood pressure. It also can cause vision problems. But added to Viagra's label were warnings that: -The FDA has received reports of heart attacks, sudden cardiac deaths and hypertension among Viagra users. -Doctors should be cautious about prescribing Viagra to men who had a heart attack, stroke or life-threatening arrhythmia in the last six months, or who have significantly low blood pressure, significantly high blood pressure - greater than 170/110, a history of cardiac failure or unstable angina or the eye disease retinitis pigmentosa. Viagra has never been studied in men with these conditions, so no one knows its safety. -Sexual activity itself is risky for certain men with cardiovascular disease; and for those men, Viagra obviously ''is inadvisable.'' -Doctors should consider whether temporary drops in blood pressure caused by Viagra, especially during sexual activity, would harm a heart patient before prescribing him the drug. -The FDA has received reports of men suffering painful, prolonged erections after taking Viagra. An erection that lasts longer than four hours requires prompt medical attention. Impotence often is a symptom of underlying heart disease or high blood pressure, or even a side effect from drugs used to treat those conditions. Thus, Pfizer stressed Tuesday that men seeking Viagra first need a full medical exam. But a consumer advocate long critical of Viagra called the warnings inadequate, saying Britain two months ago barred men who had had heart attacks or strokes from using Viagra while the FDA just urges cautious consideration of those men. ''FDA's dangerous collaboration with Pfizer, resulting in inadequate warnings, will help maintain sales of Viagra while jeopardizing the health of American men,'' said Dr. Sidney Wolfe of Public Citizen, who said there is no way to know how many men may have suffered side effects. ''This is a drug that affects blood vessels all over the body.'' The FDA has reports of 242 possible deaths among Viagra users, but only could verify that 130 occurred among Americans. The rest were foreign reports or hearsay, Rarick said. dailynews.yahoo.com