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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 (6339)	11/24/1998 5:54:00 PM
From: Anthony Wong	Respond to of 9523

Reuters: New warnings of heart risks added to Viagra label Tuesday November 24, 4:39 pm Eastern Time WASHINGTON, Nov 24 (Reuters) - New warnings about the possible heart risks of taking Viagra have been added to the drug's label, the U.S. Food and Drug Administration (FDA) said on Tuesday. The new label will say patients who have a history of heart attack or severely low blood pressure, or other kinds of heart disease, should be carefully examined before getting a prescription for the drug. The FDA said Viagra's maker, Pfizer, (NYSE:PFE - news) was changing the label to take account of reports of deaths and severe side-effects in some of the millions of men who have taken the blockbuster impotence drug since it went on the market in April. An estimated six million prescriptions have been written for the drug. ''The revised labeling addresses post-marketing reports of heart attacks, sudden cardiac deaths, and hypertension,'' the FDA said in a statement. It also said patients who have heart disease are at risk from sexual activity anyway and have to be especially careful if they use Viagra. Pfizer already issued warnings that people taking nitrate-based drugs for their heart disease must not use Viagra because the drug interaction can kill them. ''Revised in consultation with FDA, the new labeling is intended to help make sure that consumers and doctors are fully informed about the benefits and risks of using Viagra, know that consideration must be given to the cardiovascular status of patients prior to prescribing Viagra, and know how to safely use the drug,'' the FDA said. It stressed that it still feels Viagra, when prescribed as directed, is safe. biz.yahoo.com

To: Anthony Wong who wrote (6339)	11/24/1998 6:06:00 PM
From: Anthony Wong	Read Replies (1) \| Respond to of 9523

An update to the Bloomberg report at Post 6339 (with analyst comments): Pfizer's Impotence Pill Viagra to Carry New Warnings (Update1) Bloomberg News November 24, 1998, 5:31 p.m. ET Pfizer's Impotence Pill Viagra to Carry New Warnings (Update1) (Adds FDA and analyst comment, background.) Washington, Nov. 24 (Bloomberg) -- Pfizer Inc.'s impotence drug Viagra will carry new warnings to ensure its safe use, the U.S. Food and Drug Administration said. The move is just the latest in a series of additions to the label of the impotence pill, which saw unprecedented demand in its first three months on the market. As men rushed to pharmacies to get Viagra, the FDA received reports of misuse and deaths among people who had taken the drug. The FDA said the new warnings come in response to reports of ''serious adverse events'' such as heart attacks, sudden cardiac death and high blood pressure, in men who have taken the drug. The new label warns that men who have a history of heart problems should be careful about resuming sexual activity and instructs doctors to be cautious when prescribing the drug to patients with underlying health problems. Shares of New York-based Pfizer fell 2 to 114 1/8. The new labeling is ''minimally negative'' for Pfizer, said Neil Sweig, an analyst with Southeast Research Partners. ''This is really what (the FDA) has been saying for some time.'' As of mid-November, the FDA had received 130 reports of deaths among U.S. patients who had taken Viagra, said Lisa Rarick, director of the division that oversees reproductive and urological products. No Black Box The FDA still can't be sure if there's a direct link between Viagra and the heart problems and deaths reported to the agency, Rarick said. If such a link were proved, the agency could place its most dire warning -- a so-called black box -- on the drug's label, she said. ''If we felt that the link was very clear at some point, then yes, absolutely, a black box would be more appropriate,'' Rarick said. ''We're confident in continuing to say that this is a safe and effective drug,'' Rarick said. Pfizer said updating the labeling is ''a routine process'' for a new drug. The company said it would ''continue educating health-care professionals'' about the risks of Viagra use by men who are also taking heart medicines containing nitrates, such as nitroglycerin prescribed for chest pain. Sweig said Pfizer shares might fall again tomorrow as investors cash in on recent gains in the stock. ''It has the highest price-earnings valuation in the large cap drug stock group -- there could be a (market) exaggeration of modestly negative news,'' said Sweig, who has a neutral rating on Pfizer because it passed his price target. Problems have occurred only in a ''small fraction'' of the more than 3 million patients who have taken Viagra, the FDA said, and Rarick noted that label changes are a normal part of the marketing of a new drug. In this case, label changes may seem unusually frequent because of the drug's wide use, she said. Household Word Viagra became a household word after Pfizer won approval for the drug in late March. It had the most successful drug introduction in the U.S., with second-quarter sales of $411 million as wholesalers stocked up on the drug. Since then, however, sales have dropped. The drug had third- quarter sales of $141 million, below the $150 million to $200 million some analysts had expected. The new labeling will specifically warn doctors about giving Viagra to patients such as those who have suffered a stroke or have very low blood pressure or an eye condition known as retinitis pigmentosa. Those types of patients weren't studied by Pfizer in its clinical trials for Viagra, the agency said. The new label also warns about the possibility of a painful, prolonged erection that can occur rarely in patients taking Viagra. ''This is a serious condition that requires immediate medical attention,'' the FDA said. At least 16 of the 130 U.S. men who have died after taking Viagra were also taking heart medicines containing nitrates, Rarick said. Though the FDA has heard anecdotal reports that women and men who aren't impotent have tried the drug, the FDA isn't aware of any deaths among those people to date, she said. --Kristin Jensen and Kristin Reed in the Washington newsroom